Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2026-01-21 @ 11:46 AM
Study NCT ID:
NCT06541704
Status:
RECRUITING
Last Update Posted:
2025-12-18
First Post:
2024-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Investigating Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Adult Participants With Geographic Atrophy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D057092', 'term': 'Geographic Atrophy'}], 'ancestors': [{'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 975}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2032-05-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2024-08-02', 'studyFirstSubmitQcDate': '2024-08-02', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-11-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Growth rate (slope) of total GA lesion area (mm^2 /year) from baseline, measured by Fundus Autofluorescence (FAF)', 'timeFrame': 'To week 52'}], 'secondaryOutcomes': [{'measure': 'Loss of Best Corrected Visual Acuity (BCVA) ≥15 letters [Early Treatment Diabetic Retinopathy Study (ETDRS)] from baseline', 'timeFrame': 'At week 52 and week 104'}, {'measure': 'Change from baseline in Low-Contrast quantitative Visual Acuity (LC-qVA)', 'timeFrame': 'At week 52 and week 104'}, {'measure': 'Change from baseline in Low-Luminance Low-Contrast quantitative Visual Acuity (LL-LC-qVA)', 'timeFrame': 'At week 52 and week 104'}, {'measure': 'Change from baseline in quantitative Contrast Sensitivity Function (qCSF)', 'timeFrame': 'At week 52 and week 104'}, {'measure': 'Growth rate (slope) of total GA lesion area (mm^2 /year) from baseline measured by FAF', 'timeFrame': 'To week 104'}, {'measure': 'Concentrations of total pozelimab in serum', 'timeFrame': 'Through week 52 and through week 104'}, {'measure': 'Concentrations of total cemdisiran in plasma', 'timeFrame': 'Through week 52 and through week 104'}, {'measure': 'Change from baseline in concentration of total Complement component 5 (C5)', 'timeFrame': 'Through week 52 and through week 104'}, {'measure': 'Incidence of Antidrug antibody (ADA) to pozelimab', 'timeFrame': 'Through week 52 and through week 104'}, {'measure': 'Magnitude of ADA to pozelimab', 'timeFrame': 'Through week 52 and through week 104'}, {'measure': 'Incidence of ADA to cemdisiran', 'timeFrame': 'Through week 52 and through week 104'}, {'measure': 'Magnitude of ADA to cemdisiran', 'timeFrame': 'Through week 52 and through week 104'}, {'measure': 'Incidence of Neutralizing Antibody (NAb) to pozelimab', 'timeFrame': 'Through week 52 and through week 104'}, {'measure': 'Occurrence of Treatment-Emergent Adverse Events (TEAEs)', 'timeFrame': 'Through week 52, 104, 140 and week 296'}, {'measure': 'Severity of TEAEs', 'timeFrame': 'Through week 52, 104, 140 and week 296'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['GA secondary to AMD'], 'conditions': ['Age-related Macular Degeneration (AMD)', 'Geographic Atrophy (GA)']}, 'descriptionModule': {'briefSummary': 'This study is researching experimental (study) drugs called pozelimab and cemdisiran. The study is focused on participants who have Geographic Atrophy (GA) caused by Age-related Macular Degeneration (AMD). Geographic atrophy is a medical term that refers to later-stage cases of AMD which is an eye condition affecting central vision (what one sees straight ahead).\n\nThe purpose of this study is to evaluate the progression rate of Geographic Atrophy in eyes of patients treated with cemdisiran alone or in combination with pozelimab compared to those treated with placebo.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking the study drug(s)\n* How much study drug(s) are in the blood at different times\n* Whether the body makes antibodies against the study drug(s) (which could make the study drug(s) less effective or could lead to side effects)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n1. Study eye with diagnosis of GA of the macula secondary to AMD as described in the protocol\n2. Total GA area in the study eye measuring between ≥2.5 mm\\^2 and ≤17.5 mm\\^2 as described in the protocol\n3. BCVA of 55 letters or better using ETDRS charts (20/80 Snellen equivalent) in the study eye as described in the protocol\n4. Sufficiently clear ocular media, adequate pupillary dilation and fixation to permit quality fundus imaging in the study eye as described in the protocol\n5. Willing and able to comply with clinic visits and study-related procedures, including completion of the full series of meningococcal vaccinations and pneumococcal vaccination required per protocol\n\nKey Exclusion Criteria:\n\n1. GA in either eye due to causes other than AMD, such as Stargardt disease, cone rod dystrophy or toxic maculopathies like hydroxychloroquine maculopathy\n2. History or current evidence of Macular Neovascularization (MNV) and/or exudation or Peripapillary Choroidal Neovascularization (PPCNV) in either eye as described in the protocol\n3. Prior or current Intravitreal (IVT) treatment of any kind for any indication in study eye or fellow eye, except approved or investigational IVT complement inhibitor therapy or anti-VEGF therapy, as long as last dose was ≥6 months prior to randomization\n4. Prior intraocular surgery except cataract extraction or minimally invasive glaucoma surgery in study eye as long as date of these procedures was ≥3 months prior to randomization\n5. Comorbid progressive ocular condition (eg, diabetic retinopathy, macular edema, uncontrolled glaucoma, full thickness macular hole) in study eye that could affect central vision and confound study\n6. Any ophthalmologic condition that reduces the clarity of the media and that, in the opinion of the investigator interferes with ophthalmologic examination of the study eye (e.g., advanced cataract or corneal abnormalities) as described in the protocol\n\n Systemic Exclusion criteria\n7. History or current use of systemic complement inhibitor therapy within 6 months prior to randomization as described in the protocol\n8. History of solid organ or bone marrow transplantation\n9. Use of chronic (\\>14 days) systemic corticosteroids (oral or parenteral, ≥20 mg oral prednisone or equivalent) within the previous 30 days prior to the first screening visit as described in the protocol\n10. Current or prior use of systemic immunosuppressive therapy other than corticosteroids within 12 months prior to randomization or the likelihood of treatment with any such agent during the study inclusive of the screening period as described in the protocol\n11. Not meeting meningococcal or pneumococcal vaccination requirements as described in the protocol\n12. Carrier of Neisseria meningitidis based on culture collected during screening\n13. Has a hemoglobin A1C ≥ 8.0% during screening as described in the protocol\n\nNOTE: Other protocol-defined Inclusion/ Exclusion Criteria apply'}, 'identificationModule': {'nctId': 'NCT06541704', 'acronym': 'SIENNA', 'briefTitle': 'A Study Investigating Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Adult Participants With Geographic Atrophy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Regeneron Pharmaceuticals'}, 'officialTitle': 'A Multicenter, Randomized, Double-Masked, Placebo-Controlled Phase 3 Study of the Efficacy, Safety, and Tolerability of Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration', 'orgStudyIdInfo': {'id': 'R3918-AMD-2326'}, 'secondaryIdInfos': [{'id': '2023-509547-27-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pozelimab + Cemdisiran treatment group', 'description': 'Randomized 1:1:1', 'interventionNames': ['Drug: Pozelimab', 'Drug: Cemdisiran']}, {'type': 'EXPERIMENTAL', 'label': 'Cemdisiran monotherapy treatment group', 'description': 'Randomized 1:1:1', 'interventionNames': ['Drug: Cemdisiran']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo treatment group', 'description': 'Randomized 1:1:1', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Pozelimab', 'type': 'DRUG', 'otherNames': ['REGN3918'], 'description': 'Subcutaneous (SC) injection', 'armGroupLabels': ['Pozelimab + Cemdisiran treatment group']}, {'name': 'Cemdisiran', 'type': 'DRUG', 'otherNames': ['ALN-CC5'], 'description': 'SC injection', 'armGroupLabels': ['Cemdisiran monotherapy treatment group', 'Pozelimab + Cemdisiran treatment group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'SC injection', 'armGroupLabels': ['Placebo treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85016', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Barnet Dulaney Perkins Eye Center', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85020', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Associated Retina Consultants', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85053', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Retinal Research Institute', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Retina Associates of Tuscan', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72764', 'city': 'Springdale', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Retina Partners of Northwest Arkansas, PLLC', 'geoPoint': {'lat': 36.18674, 'lon': -94.12881}}, {'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Retina Vitreous Associates Medical Group', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '91436', 'city': 'Encino', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'The Retina Partners', 'geoPoint': {'lat': 34.15917, 'lon': -118.50119}}, {'zip': '93720', 'city': 'Fresno', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Eye Medical Center of Fresno', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '92835', 'city': 'Fullerton', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Retina Consultants of Orange County', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'zip': '92647', 'city': 'Huntington Beach', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Salehi Retina Institute dba Retina Associates of Southern California', 'geoPoint': {'lat': 33.6603, 'lon': -117.99923}}, {'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of California San Diego, Jacobs Retina Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90807', 'city': 'Long Beach', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'South Coast Retina Center', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '90017', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'American Institute of Research', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95356', 'city': 'Modesto', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Retinal Consultants Medical Group Inc Modesto', 'geoPoint': {'lat': 37.6391, 'lon': -120.99688}}, {'zip': '94040', 'city': 'Mountain View', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Northern California Retina Vitreous Associates Medical Group, Inc.', 'geoPoint': {'lat': 37.38605, 'lon': -122.08385}}, {'zip': '93036', 'city': 'Oxnard', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'California Retina Consultants', 'geoPoint': {'lat': 34.1975, 'lon': -119.17705}}, {'zip': '91107', 'city': 'Pasadena', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'California Eye Specialists Medical Group Inc.', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'zip': '92064', 'city': 'Poway', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Retina Consultants San Diego', 'geoPoint': {'lat': 32.96282, 'lon': -117.03586}}, {'zip': '92373', 'city': 'Redlands', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'California Eye Specialists Medical Group, Inc.', 'geoPoint': {'lat': 34.05557, 'lon': -117.18254}}, {'zip': '95825', 'city': 'Sacramento', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Vrmg Inc', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '95841', 'city': 'Sacramento', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Retinal Consultants Medical Group (RCMG) - Greenback Lane Retina Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '94109', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'West Coast Retina Medical Group, Inc.', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '92705', 'city': 'Santa Ana', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Orange County Retina Medical Group', 'geoPoint': {'lat': 33.74557, 'lon': -117.86783}}, {'zip': '90503', 'city': 'Torrance', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Macula Retina Vitreous Research Institute', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Colorado', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80909', 'city': 'Colorado Springs', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Retina Consultants of Southern Colorado', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '81303', 'city': 'Durango', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Southwest Retina Research Center', 'geoPoint': {'lat': 37.27528, 'lon': -107.88007}}, {'zip': '80228', 'city': 'Lakewood', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Colorado Retina - Lakewood', 'geoPoint': {'lat': 39.70471, 'lon': -105.08137}}, {'zip': '80503', 'city': 'Longmont', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Eye care Center of Northern Colorado doing business as Advanced Vision Research Institute', 'geoPoint': {'lat': 40.16721, 'lon': -105.10193}}, {'zip': '06385', 'city': 'Waterford', 'state': 'Connecticut', 'status': 'TERMINATED', 'country': 'United States', 'facility': 'Retina Group of New England', 'geoPoint': {'lat': 41.3417, 'lon': -72.13597}}, {'zip': '33067', 'city': 'Coral Springs', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Advanced Research', 'geoPoint': {'lat': 26.27119, 'lon': -80.2706}}, {'zip': '33308', 'city': 'Fort Lauderdale', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Retina Group of Florida', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33912', 'city': 'Fort Myers', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'National Ophthalmic Research Institute', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '32216', 'city': 'Jacksonville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Florida Retina Institute, Jacksonville Perimeter Park- Ophthalmology', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33805', 'city': 'Lakeland', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Florida Retina Consultants', 'geoPoint': {'lat': 28.03947, 'lon': -81.9498}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Florida Retina Institute - Orlando', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33410', 'city': 'Palm Beach Gardens', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Retina Care Specialists', 'geoPoint': {'lat': 26.82339, 'lon': -80.13865}}, {'zip': '34232', 'city': 'Sarasota', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Retina Group of Florida, RAS-Sarasota Retina Center-Ophthalmology', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '33711', 'city': 'St. Petersburg', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Retina Vitreous Associates of Florida Saint Petersburg', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of South Florida Ophthalmology', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30909', 'city': 'Augusta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Southeast Retina Center', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '30060', 'city': 'Marietta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Georgia Retina - Marietta', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '60616', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Retinal Vitreal Consultants', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'The University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60439', 'city': 'Lemont', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University Retina and Macula Associates PC - Lemont', 'geoPoint': {'lat': 41.67364, 'lon': -88.00173}}, {'zip': '60304', 'city': 'Oak Park', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Illinois Retina Associates', 'geoPoint': {'lat': 41.88503, 'lon': -87.7845}}, {'zip': '62703', 'city': 'Springfield', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Springfield Clinic Main Campus East', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '66215', 'city': 'Lenexa', 'state': 'Kansas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Retina Associates, LLC', 'geoPoint': {'lat': 38.95362, 'lon': -94.73357}}, {'zip': '70006', 'city': 'Metairie', 'state': 'Louisiana', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Retina Associates New Orleans', 'geoPoint': {'lat': 29.98409, 'lon': -90.15285}}, {'zip': '70006', 'city': 'Metairie', 'state': 'Louisiana', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Ross Davis Retina', 'geoPoint': {'lat': 29.98409, 'lon': -90.15285}}, {'zip': '71291', 'city': 'West Monroe', 'state': 'Louisiana', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Eye Assoc. of NE LA dba Haik Humble Eye Ctr', 'geoPoint': {'lat': 32.51848, 'lon': -92.14764}}, {'zip': '71291', 'city': 'West Monroe', 'state': 'Louisiana', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Eye Associates of Northeast Louisiana dba Haik Humble Eye Center', 'geoPoint': {'lat': 32.51848, 'lon': -92.14764}}, {'zip': '21209', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'The Retina Care Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21740', 'city': 'Hagerstown', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Cumberland Valley Retina Consultants-Ophthalmology', 'geoPoint': {'lat': 39.64176, 'lon': -77.71999}}, {'zip': '21740', 'city': 'Hagerstown', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Mid Atlantic Retina Specialist', 'geoPoint': {'lat': 39.64176, 'lon': -77.71999}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Opthalmic Consultants of Boston', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '01107', 'city': 'Springfield', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'New England Retina Consultants, PC', 'geoPoint': {'lat': 42.10148, 'lon': -72.58981}}, {'zip': '39110', 'city': 'Madison', 'state': 'Mississippi', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Mississippi Retina Associates', 'geoPoint': {'lat': 32.46181, 'lon': -90.11536}}, {'zip': '38671', 'city': 'Southaven', 'state': 'Mississippi', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Deep Blue Retina Clinical Research PLLC', 'geoPoint': {'lat': 34.98898, 'lon': -90.01259}}, {'zip': '63144', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Retina Research Institute, LLC', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '08034', 'city': 'Cherry Hill', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Mid Atlantic Retina - Cherry Hill', 'geoPoint': {'lat': 39.93484, 'lon': -75.03073}}, {'zip': '08755', 'city': 'Toms River', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'New Jersey Retina', 'geoPoint': {'lat': 39.95373, 'lon': -74.19792}}, {'zip': '11717', 'city': 'Brentwood', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Sight MD', 'geoPoint': {'lat': 40.78121, 'lon': -73.24623}}, {'zip': '13088', 'city': 'Liverpool', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Retina Vitreous Surgeons of Central New York, PC', 'geoPoint': {'lat': 43.10646, 'lon': -76.2177}}, {'zip': '28803', 'city': 'Asheville', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Western Carolina Retinal Associates', 'geoPoint': {'lat': 35.60095, 'lon': -82.55402}}, {'zip': '28602', 'city': 'Hickory', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Graystone Eye', 'geoPoint': {'lat': 35.73319, 'lon': -81.3412}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Piedmont Retina Specialist', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '45242', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Cincinnati Eye Institute', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43212', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'The Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '43016', 'city': 'Dublin', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Midwest Retina, Inc', 'geoPoint': {'lat': 40.09923, 'lon': -83.11408}}, {'zip': '73013', 'city': 'Edmond', 'state': 'Oklahoma', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Retina Vitreous Center - Edmond', 'geoPoint': {'lat': 35.65283, 'lon': -97.4781}}, {'zip': '74114', 'city': 'Tulsa', 'state': 'Oklahoma', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Tulsa Retina Consultants', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'zip': '97401', 'city': 'Eugene', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Verum Research LLC', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}, {'zip': '97221', 'city': 'Portland', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Retina Northwest, The Highlands Building', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '97225', 'city': 'Portland', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'EyeHealth Northwest', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '97477', 'city': 'Springfield', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Cascade Medical Research Institute LLC', 'geoPoint': {'lat': 44.04624, 'lon': -123.02203}}, {'zip': '18017', 'city': 'Bethlehem', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Mid Atlantic Retina', 'geoPoint': {'lat': 40.62593, 'lon': -75.37046}}, {'zip': '16507', 'city': 'Erie', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Erie Retinal Surgery & Erie Retina Research', 'geoPoint': {'lat': 42.12922, 'lon': -80.08506}}, {'zip': '15143', 'city': 'Sewickley', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Sewickley Eye Group', 'geoPoint': {'lat': 40.53646, 'lon': -80.1845}}, {'zip': '29605', 'city': 'Greenville', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Retina Consultants of Carolina', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '29456', 'city': 'Ladson', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Charleston Neuroscience Institute LLC', 'geoPoint': {'lat': 32.98573, 'lon': -80.10981}}, {'zip': '29464', 'city': 'Mt. Pleasant', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Charleston Neuroscience Institute, LLC', 'geoPoint': {'lat': 32.79407, 'lon': -79.86259}}, {'zip': '29169', 'city': 'West Columbia', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Palmetto Retina Center', 'geoPoint': {'lat': 33.99349, 'lon': -81.07398}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Tennessee Retina, PC', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Austin Research Center for Retina', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Austin Retina Associates', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77401', 'city': 'Bellaire', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Retina Consultants Texas', 'geoPoint': {'lat': 29.70579, 'lon': -95.45883}}, {'zip': '76028', 'city': 'Burleson', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Star Retina PLLC', 'geoPoint': {'lat': 32.54208, 'lon': -97.32085}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Retina Foundation of the Southwest', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Texas Retina Associates', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77494', 'city': 'Katy', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Retina Consultants of Texas', 'geoPoint': {'lat': 29.78579, 'lon': -95.8244}}, {'zip': '78503', 'city': 'McAllen', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Valley Retina Institute, P.A.', 'geoPoint': {'lat': 26.20341, 'lon': -98.23001}}, {'zip': '75024', 'city': 'Plano', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Red River Research Partners (Formerly AXIS Clinical)', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}, {'zip': '78681', 'city': 'Round Rock', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Austin Retina Associates', 'geoPoint': {'lat': 30.50826, 'lon': -97.6789}}, {'zip': '78240', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Medical Center Ophthalmology Associates', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78240', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Retina Associates of South Texas', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78240', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Retina Consultants of Texas', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78251', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Retina Consultants of Texas Brown Retina Institute', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '76092', 'city': 'Southlake', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Retina Center of Texas', 'geoPoint': {'lat': 32.94124, 'lon': -97.13418}}, {'zip': '77384', 'city': 'The Woodlands', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Retina Consultants Texas', 'geoPoint': {'lat': 30.15799, 'lon': -95.48938}}, {'zip': '84107', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Retina Associates Of Utah Retina Specialist', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '24502', 'city': 'Lynchburg', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Piedmont Eye Center', 'geoPoint': {'lat': 37.41375, 'lon': -79.14225}}, {'zip': '23226', 'city': 'Richmond', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Virginia Eye Institute', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '23235', 'city': 'Richmond', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Retina Institute of Virginia', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '8036', 'city': 'Graz', 'state': 'Styria', 'status': 'RECRUITING', 'country': 'Austria', 'facility': 'Medical University Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': '1090', 'city': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'facility': 'Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '1140', 'city': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'facility': 'VIROS - Vienna Institute for Research in Ocular Surgery', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': 'K2B 7E9', 'city': 'Ottawa', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'Retina Centre of Ottawa - Department of Ophthalmology', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': '94010', 'city': 'Créteil', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Centre Hospitalier Intercommunal de Creteil', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '13008', 'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Centre Monticelli Paradis', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '12203', 'city': 'Berlin', 'state': 'Brandenburg', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Charite - Universitaetsmedizin Berlin'}, {'zip': '35043', 'city': 'Marburg', 'state': 'Hesse', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Universitaetsklinikum Marburg, Klinik fuer Augenheilkunde', 'geoPoint': {'lat': 50.80904, 'lon': 8.77069}}, {'zip': '17036', 'city': 'Neubrandenburg', 'state': 'Mecklenburg-Vorpommern', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Dietrich Bonhoeffer Klinikum', 'geoPoint': {'lat': 53.55735, 'lon': 13.26105}}, {'zip': '40225', 'city': 'Düsseldorf', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Klinik fur Augenheilkunde Universitatsklinikum Dusseldorf', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': '48149', 'city': 'Münster', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Universitaetsklinikum Muenster', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'zip': '66421', 'city': 'Homburg', 'state': 'Saarland', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Saarland University Medical Center', 'geoPoint': {'lat': 49.32637, 'lon': 7.33867}}, {'zip': '66280', 'city': 'Sulzbach', 'state': 'Saarland', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Knappschaftsklinikum Saar GmbH- Eye Clnic Sulzbach', 'geoPoint': {'lat': 49.29882, 'lon': 7.05696}}, {'zip': '48145', 'city': 'Münster', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'St. Franziskus-Hospital', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'zip': '7621', 'city': 'Pécs', 'state': 'Baranya', 'status': 'RECRUITING', 'country': 'Hungary', 'facility': 'Ganglion Medical Center', 'geoPoint': {'lat': 46.07617, 'lon': 18.22814}}, {'zip': '6720', 'city': 'Szeged', 'state': 'Csongrad-Csanad', 'status': 'RECRUITING', 'country': 'Hungary', 'facility': 'University Of Szeged', 'geoPoint': {'lat': 46.253, 'lon': 20.14824}}, {'zip': '4032', 'city': 'Debrecen', 'state': 'Hajdú-Bihar', 'status': 'RECRUITING', 'country': 'Hungary', 'facility': 'University Of Debrecen, Hungary', 'geoPoint': {'lat': 47.53167, 'lon': 21.62444}}, {'zip': '1133', 'city': 'Budapest', 'status': 'RECRUITING', 'country': 'Hungary', 'facility': 'Budapest Retina Associates', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '00168', 'city': 'Rome', 'state': 'Lazio', 'status': 'RECRUITING', 'country': 'Italy', 'facility': 'Fondazione Policlinico Gemelli', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '20123', 'city': 'Milan', 'state': 'Lombardy', 'status': 'RECRUITING', 'country': 'Italy', 'facility': 'IRCCS MultiMedica', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '50134', 'city': 'Florence', 'state': 'Tuscany', 'status': 'RECRUITING', 'country': 'Italy', 'facility': 'Azienda Ospedaliero Universitaria Careggi', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': '20157', 'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'facility': 'Universita degli Studi di Milano', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '85-631', 'city': 'Bydgoszcz', 'state': 'Kuyavian-Pomeranian Voivodeship', 'status': 'RECRUITING', 'country': 'Poland', 'facility': 'Oftalmika Sp. z o.o.', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}, {'zip': '10-424', 'city': 'Olsztyn', 'state': 'Warmian-Masurian Voivodeship', 'status': 'RECRUITING', 'country': 'Poland', 'facility': 'Centrum Diagnostyki I Mikrochirurgii Oka Lens Sp zoo', 'geoPoint': {'lat': 53.78376, 'lon': 20.49272}}, {'zip': '14012', 'city': 'Córdoba', 'state': 'Andalusia', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Arruzafa', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}, {'zip': '8907', 'city': "L'Hospitalet de Llobregat", 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Bellvitge University Hospital', 'geoPoint': {'lat': 41.35967, 'lon': 2.10028}}, {'zip': '08227', 'city': 'Terrassa', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital de Terrassa (Consorci Sanitari de Terrassa)', 'geoPoint': {'lat': 41.56667, 'lon': 2.01667}}, {'zip': '46100', 'city': 'Burjassot', 'state': 'Valencia', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Oftalvist Clinic. IMED Hospital', 'geoPoint': {'lat': 39.50984, 'lon': -0.41327}}, {'zip': '08021', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Centro de Oftalmologia Barraquer', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08035', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Instituto de Microcirugia Ocular', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '8022', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Institut Catala De Retina S.L.', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '41009', 'city': 'Seville', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen Macarena Unidad Coronaria 1 planta', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': 'YP31 8HE', 'city': 'York', 'state': 'North Yorkshire', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'York and Scarborough Teaching Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 53.95763, 'lon': -1.08271}}, {'zip': 'BS1 2LX', 'city': 'Bristol', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'University Hospitals Bristol NHS Foundation Trust', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}], 'centralContacts': [{'name': 'Clinical Trials Administrator', 'role': 'CONTACT', 'email': 'clinicaltrials@regeneron.com', 'phone': '844-734-6643'}], 'overallOfficials': [{'name': 'Clinical Trial Management', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Regeneron Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'When Regeneron has:\n\n* received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development\n* made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)\n* the legal authority to share the data, and\n* ensured the ability to protect participant privacy.', 'ipdSharing': 'YES', 'description': 'All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.', 'accessCriteria': "Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regeneron Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}