Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-24 @ 11:28 PM
Study NCT ID:
NCT04108156
Status:
RECRUITING
Last Update Posted:
2025-12-17
First Post:
2019-09-26
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate Efficacy, Safety & Pharmacokinetics of the Port Delivery System (PDS) With Ranibizumab in Participants With Diabetic Macular Edema (DME) Compared With Intravitreal Ranibizumab; A Substudy to Evaluate the Safety of Re-implanting the PDS With Ranibizumab in Participants With DME
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069579', 'term': 'Ranibizumab'}, {'id': 'D007267', 'term': 'Injections'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The substudy is a non-randomized, open-label study.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 634}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2025-12', 'dispFirstSubmitDate': '2023-09-07', 'completionDateStruct': {'date': '2027-11-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2019-09-26', 'studyFirstSubmitQcDate': '2019-09-26', 'dispFirstPostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-11-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in BCVA Score From Baseline Averaged Over Weeks 60 and 64 as Measured Using the ETDRS Chart in the Efficacy Population Using a Treatment Policy Strategy for all Intercurrent Events', 'timeFrame': 'Baseline to Week 64', 'description': 'BCVA = Best-Corrected Visual Acuity\n\nETDRS = Early Treatment Diabetic Retinopathy Study\n\nA vision score of 20/20 vision is considered normal. A score of 20/200 is considered being legally blind.'}, {'measure': 'Substudy: Number of Participants With Ocular and Systemic (Non-ocular) Adverse Events (AEs) and Severity of Ocular and Systemic AEs', 'timeFrame': 'Baseline to Week 72'}, {'measure': 'Substudy: Number of Participants With Adverse Events of Special Interests (AESIs) and Severity of AESIs', 'timeFrame': 'Baseline to Week 72'}, {'measure': 'Substudy: Duration of AESIs', 'timeFrame': 'Baseline to Week 72'}, {'measure': 'Substudy: Number of Participants With Ocular AESIs and Severity of Ocular AESIs During the Post-operative Period', 'timeFrame': 'Up to Day 37 post re-implantation'}, {'measure': 'Substudy: Number of Participants With Ocular AESIs and Severity of Ocular AESIs During the Follow-up Period', 'timeFrame': '> 37 days post-implantation (up to approximately 72 weeks)'}, {'measure': 'Substudy: Duration of Ocular AESIs During the Post-operative Period', 'timeFrame': 'Up to Day 37 post re-implantation'}, {'measure': 'Substudy: Duration of Ocular AESIs During the Follow-up Period', 'timeFrame': '> 37 days post-implantation (up to approximately 72 weeks)'}, {'measure': 'Substudy: Number of Participants With Adverse Device Effects (ADEs) and Severity of ADEs', 'timeFrame': 'Baseline to Week 72'}, {'measure': 'Substudy: Number of Participants With Anticipated Serious ADEs', 'timeFrame': 'Baseline to Week 72'}, {'measure': 'Substudy: Duration of Serious ADEs', 'timeFrame': 'Baseline to Week 72'}, {'measure': 'Substudy: Number of Device Deficiencies', 'timeFrame': 'Baseline to Week 72'}], 'secondaryOutcomes': [{'measure': 'Change in BCVA Score From Baseline Averaged Over Weeks 60 and 64 as Measured With Use of the ETDRS Chart in the Modified Intent-to-treat (mITT) Population Using a Treatment Policy Strategy for All Intercurrent Events', 'timeFrame': 'Baseline to Week 64', 'description': 'ETDRS-DRSS = ETDRS Diabetic Retinopathy Severity Scale'}, {'measure': 'Change in BCVA Score From Baseline Averaged Over Weeks 60 and 64 as Measured With Use of the ETDRS Chart in the mITT Population Using a Hypothetical Strategy for All Intercurrent Events', 'timeFrame': 'Baseline to Week 64'}, {'measure': 'Percentage of Participants With a ≥2-step Improvement From Baseline on the ETDRS-DRSS at Week 64 in the Efficacy Population', 'timeFrame': 'Baseline to Week 64'}, {'measure': 'Percentage of Participants With a ≥2-step Improvement From Baseline on the ETDRS-DRSS at Week 64 in the mITT population', 'timeFrame': 'Baseline to Week 64'}, {'measure': 'Change from Baseline in BCVA as Measured on the ETDRS Chart Over Time', 'timeFrame': 'Baseline up to Week 120'}, {'measure': 'Percentage of Participants Who Lose <15, <10, and <5 letters in BCVA From Baseline Over Time', 'timeFrame': 'Baseline up to Week 120'}, {'measure': 'Percentage of Participants Who Gain ≥15, ≥10, ≥5, ≥0 Letters in BCVA From Baseline Over Time', 'timeFrame': 'Baseline up to Week 120'}, {'measure': 'Percentage of Participants With a BCVA Snellen Equivalent of 20/40 or Better Over Time', 'timeFrame': 'Baseline up to Week 120'}, {'measure': 'Percentage of Participants With a BCVA Snellen Equivalent of 20/200 or Worse Over Time', 'timeFrame': 'Baseline up to Week 120'}, {'measure': 'Percentage of Participants With a ≥2-step Improvement From Baseline on the ETDRS-DRSS Over Time', 'timeFrame': 'Baseline up to Week 120'}, {'measure': 'Percentage of Participants With a ≥3-step Improvement From Baseline on the ETDRS-DRSS Over Time', 'timeFrame': 'Baseline up to Week 120'}, {'measure': 'Time to ≥2-step Worsening From Baseline on the ETDRS-DRSS', 'timeFrame': 'Baseline up to Week 120'}, {'measure': 'Time to ≥3-step Worsening From Baseline on the ETDRS-DRSS', 'timeFrame': 'Baseline up to Week 120'}, {'measure': 'Change From Baseline in ETDRS-DRSS Score Over Time', 'timeFrame': 'Baseline up to Week 120'}, {'measure': 'Change From Baseline in Central Subfield Thickness (CST) as Measured on Spectral Domain Optical Coherence Tomography (SD-OCT) Over Time', 'timeFrame': 'Baseline up to Week 120'}, {'measure': 'Change From Baseline in Total Macular Volume as Measured on SD-OCT Over Time', 'timeFrame': 'Baseline up to Week 120'}, {'measure': 'Percentage of Participants With Absence of Intraretinal Fluid (IRF) Over Time (IRF as Measured in the Central 1 mm Subfield)', 'timeFrame': 'Baseline up to Week 120'}, {'measure': 'Percentage of Participants With Absence of Subretinal Fluid (SRF) Over Time (SRF as Measured in the Central 1 mm Subfield)', 'timeFrame': 'Baseline up to Week 120'}, {'measure': 'Percentage of Participants With Absence of IRF and SRF Over Time', 'timeFrame': 'Baseline up to Week 120'}, {'measure': 'Percentage of Participants With Absence DME (Defined as CST ≥325 μm on SD-OCT) Over Time', 'timeFrame': 'Baseline up to Week 120', 'description': 'DME = diabetic macular edema'}, {'measure': 'Time to PDR (Defined as a Score ≥60 on the ETDRS-DRSS)', 'timeFrame': 'Baseline up to Week 120', 'description': 'PDR = proliferative diabetic retinopathy'}, {'measure': 'Percentage of Participants Who do not Undergo Supplemental Treatment With IVT Ranibizumab Within Each Refill-exchange Interval', 'timeFrame': 'Baseline up to Week 120'}, {'measure': 'Percentage of Participants Who Report Preferring PDS Treatment Compared With IVT Ranibizumab Treatment', 'timeFrame': 'Baseline to Week 64', 'description': 'As measured by the PDS patient preference questionnaire (PPPQ) at Week 64 among participants in the PDS arm efficacy population, mITT population'}, {'measure': 'Percentage of Participants Who Report Preferring PDS Treatment Compared With IVT Ranibizumab Treatment, as Measured by the PPPQ at Week 64', 'timeFrame': 'Baseline to Week 64', 'description': 'Participants in a subset of patients with bilateral disease who are simultaneously receiving ranibizumab via study eye PDS implant and fellow eye IVT injection.'}, {'measure': 'Participant-reported Vision-related Functioning and Health-Related Quality of Life (HRQoL) Among Participants in Both Treatment Arms, as Measured by Changes From Baseline', 'timeFrame': ', Baseline Week 48, Week 96', 'description': 'As measured by in the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) composite score and Near Activities, Distance Activities, and Driving subscale scores'}, {'measure': 'Participant-reported Vision-related Functioning and HRQoL, as Measured by the Proportion of Participants With a ≥ 4-Point Improvement From Baseline in the NEI VFQ-25 Composite Score at Weeks 48 and 96 Among Participants in Both Treatment Arms', 'timeFrame': 'Baseline, Week 48, Week 96'}, {'measure': 'Incidence and Severity of Ocular AEs', 'timeFrame': 'Baseline to Week 120'}, {'measure': 'Incidence and Severity of Non-ocular AEs', 'timeFrame': 'Baseline up to Week 120'}, {'measure': 'Incidence, Severity, and Duration of AEs of Special Interest', 'timeFrame': 'Baseline up to Week 120'}, {'measure': 'Serum Concentration of Ranibizumab Observed Over Time', 'timeFrame': 'Baseline up to Week 120'}, {'measure': 'PK Parameter: Value Area Under the Concentration- Time Curve Over 24 weeks (AUC24W)', 'timeFrame': 'Baseline to Week 24'}, {'measure': 'PK Parameter: Maximum Serum Concentration (Cmax)', 'timeFrame': 'Baseline up to Week 120'}, {'measure': 'PK Parameter: Minimum Serum Concentration (Cmin)', 'timeFrame': 'Baseline up to Week 120'}, {'measure': 'Time of Maximum Observed Serum Concentration (Tmax) After PDS Implant Insertion', 'timeFrame': 'Baseline up to Week 120'}, {'measure': 'Prevalence of Anti-drug Antibodies (ADAs) at Baseline and Incidence of ADAs During the Study', 'timeFrame': 'Baseline up to Week 120'}, {'measure': 'Prevalence of Neutralizing Antibodies at Baseline and Incidence of Neutralizing Antibodies During the Study', 'timeFrame': 'Baseline up to Week 120'}, {'measure': 'Reported Incidence of Device Deficiencies', 'timeFrame': 'Baseline up to Week 120'}, {'measure': 'Incidence and Severity of Ocular AEs', 'timeFrame': 'Baseline up to Week 120'}, {'measure': 'Incidence, Severity, and Duration of AESIs', 'timeFrame': 'Baseline up to Week 120'}, {'measure': 'Incidence, Severity, and Duration of Ocular AESIs During the Postoperative Period (up to 37 Days After Initial Implantation) and Follow-up Period (> 37 days After Implantation Surgery)', 'timeFrame': 'Baseline up to Week 120'}, {'measure': 'Incidence and Severity of ADEs', 'timeFrame': 'Baseline up to Week 120'}, {'measure': 'Incidence, Causality, Severity, and Duration of Anticipated Serious ADEs', 'timeFrame': 'Baseline up to Week 120'}, {'measure': 'Substudy: Number of Participants With Ocular AESIs and Severity of Ocular AESIs After Refill-exchange Procedure', 'timeFrame': 'Up to approximately 72 weeks'}, {'measure': 'Substudy: Duration of AESIs After Refill-exchange Procedure', 'timeFrame': 'Up to approximately 72 weeks'}, {'measure': 'Substudy: Number of Participants With ADEs and Severity of ADEs After Refill-exchange Procedure', 'timeFrame': 'Up to approximately 72 weeks'}, {'measure': 'Substudy: Number of Participants With Anticipated Serious ADEs After Refill-exchange Procedure', 'timeFrame': 'Up to approximately 72 weeks'}, {'measure': 'Substudy: Duration of Serious ADEs After Refill-exchange Procedure', 'timeFrame': 'Up to approximately 72 weeks'}, {'measure': 'Substudy: Number of Device Deficiencies After Refill-exchange Procedure', 'timeFrame': 'Up to approximately 72 weeks'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Port Delivery System'], 'conditions': ['Diabetic Macular Edema']}, 'referencesModule': {'references': [{'pmid': '40048197', 'type': 'DERIVED', 'citation': 'Khanani AM, Campochiaro PA, Graff JM, Marcus DM, Miller D, Mittra RA, Regillo C, Sheth VS, Bobbala A, Gune S, Lin S, Quezada-Ruiz C, Malhotra V. Continuous Ranibizumab via Port Delivery System vs Monthly Ranibizumab for Treatment of Diabetic Macular Edema: The Pagoda Randomized Clinical Trial. JAMA Ophthalmol. 2025 Apr 1;143(4):326-335. doi: 10.1001/jamaophthalmol.2025.0006.'}, {'pmid': '37585454', 'type': 'DERIVED', 'citation': 'Stockwell AD, Chang MC, Mahajan A, Forrest W, Anegondi N, Pendergrass RK, Selvaraj S, Reeder J, Wei E, Iglesias VA, Creps NM, Macri L, Neeranjan AN, van der Brug MP, Scales SJ, McCarthy MI, Yaspan BL. Multi-ancestry GWAS analysis identifies two novel loci associated with diabetic eye disease and highlights APOL1 as a high risk locus in patients with diabetic macular edema. PLoS Genet. 2023 Aug 16;19(8):e1010609. doi: 10.1371/journal.pgen.1010609. eCollection 2023 Aug.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the efficacy, safety, and Pharmacokinetics (PK) of the PDS with ranibizumab in participants with DME when treated every 24 weeks (Q24W) compared with intravitreal (IVT) ranibizumab 0.5 milligrams (mg) every 4 weeks (Q4W).\n\nThe substudy will evaluate safety of re-implanting the updated PDS with ranibizumab and the refill-exchange procedures following re-implantation in participants with DME who were previously enrolled in the main study, GR40550. Up to 100 participants from the main study will be enrolled and followed for a maximum of 72 weeks post-re-implantation in the substudy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥18 years at time of signing informed consent form (ICF)\n* Documented diagnosis of diabetes mellitus (Type 1 or Type 2)\n* Glycated haemoglobin (HbA1c) level of ≤10% within 2 months prior to screening or at screening\n\nStudy eye\n\n* Macular thickening secondary to DME involving the center of the fovea with CST ≥325 micrometer (µm) on SD-OCT at screening\n* BCVA score of 78 to 25 letters (20/32 to 20/320 approximate Snellen equivalent)\n\nExclusion Criteria:\n\n* High-risk PDR\n* Active intraocular inflammation (grade trace or above)\n* Suspected or active ocular or periocular infection of either eye\n* Uncontrolled ocular hypertension or glaucoma and any such condition the investigator determines may require a glaucoma-filtering surgery during a patient's participation in the study\n* Cerebrovascular accident or myocardial infarction within 6 months prior to randomization\n* Atrial fibrillation diagnosis or worsening within 6 months prior to randomization\n* Uncontrolled blood pressure\n\nSubstudy:\n\nInclusion Criteria:\n\n* Having experienced a septum dislodgement in the original implant while in the main study or after exiting the main study\n* Sufficiently clear ocular media and adequate pupillary dilation to allow for analysis and grading by central reading center\n\nExclusion Criteria (Cohort 1 Only):\n\n* Recent history (in the last 3 months prior to enrollment) of other disease, other non-diabetic metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a condition that contraindicates the use of ranibizumab or surgical placement of the PDS implant; that might affect interpretation of the results of the study; or that renders the participant at high risk for treatment complications\n* Active cancer within the last 12 months, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or prostate cancer\n* Current systemic treatment for a confirmed active systemic infection\n* Participation in an investigational trial that involves treatment with any drug or device (with the exception of vitamins and minerals or enrollment in Study GR40550) within 6 months prior to enrollment\n* Use of antimitotic or antimetabolite therapy within 30 days\n\nOcular Exclusion Criteria for Study Eye:\n\n* Any ocular condition that may render the participant at high risk for surgical or treatment complications\n* Intraocular surgery (including cataract surgery) within 1 month preceding the enrollment visit\n* Any use of medicated intraocular implants (other than the PDS implant), at any time prior to enrollment\n* History of rhegmatogenous retinal tears or peripheral retinal breaks within 3 months prior to the enrollment visit\n* Any concurrent ocular condition that would require surgical intervention during the study to prevent or treat visual loss\n* Concurrent conjunctival, tenon's capsule, and/or scleral condition in the supero-temporal quadrant of the eye (e.g., scarring, thinning, mass) that may affect the refill-exchange procedure of the PDS implant\n* Ongoing ocular complications that might affect participant safety Ocular Exclusion Criteria for Either Eye\n* Suspected or active ocular or periocular infection (e.g., infectious conjunctivitis or endophthalmitis)\n* Any history of uveitis\n* Active blepharitis"}, 'identificationModule': {'nctId': 'NCT04108156', 'acronym': 'Pagoda', 'briefTitle': 'A Study to Evaluate Efficacy, Safety & Pharmacokinetics of the Port Delivery System (PDS) With Ranibizumab in Participants With Diabetic Macular Edema (DME) Compared With Intravitreal Ranibizumab; A Substudy to Evaluate the Safety of Re-implanting the PDS With Ranibizumab in Participants With DME', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Phase III, Multicenter, Randomized, Visual Assessor-Masked, Active-comparator Study of the Efficacy, Safety, and Pharmacokinetics of the Port Delivery System With Ranibizumab in Patients With Diabetic Macular Edema (Pagoda)', 'orgStudyIdInfo': {'id': 'GR40550'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PDS Arm', 'description': 'Participants randomized to the PDS arm will receive IVT ranibizumab injection Q4W (loading phase) and will then have the PDS implant (pre-filled with ranibizumab) surgically inserted. PDS implant refill-exchange procedures will be performed on a fixed interval Q24W thereafter.', 'interventionNames': ['Drug: PDS Implant Pre-Filled with 100 mg/mL Ranibizumab', 'Drug: Ranibizumab refill exchange']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intravitreal Arm', 'description': 'Participants randomized to the intravitreal arm will receive IVT ranibizumab injection Q4W until they receive the PDS implant (pre-filled with ranibizumab). PDS implant refill-exchange procedures will be performed on a fixed interval Q24W thereafter.', 'interventionNames': ['Drug: Intravitreal Ranibizumab 0.5 mg Injection', 'Drug: Ranibizumab refill exchange']}, {'type': 'EXPERIMENTAL', 'label': 'Substudy: Cohort 1', 'description': 'Participants will undergo re-implantation with the updated PDS implant (pre-filled with ranibizumab 100 milligrams per milliliter \\[mg/mL\\]) on Day 1 (or enrollment visit) and then will have two refill-exchanges (ranibizumab 100 mg/mL) Q24W up to 48 weeks.', 'interventionNames': ['Drug: PDS Implant Pre-Filled with 100 mg/mL Ranibizumab', 'Drug: Ranibizumab refill exchange']}, {'type': 'EXPERIMENTAL', 'label': 'Substudy: Cohort 2a', 'description': 'Participants who received an updated PDS implant, have \\< 24 weeks post-re-implantation follow-up and no scheduled refill-exchange visit in the main study, will undergo two refill-exchange procedures (ranibizumab 100 mg/mL) Q24W, post main study re-implantation visit.', 'interventionNames': ['Drug: Ranibizumab refill exchange']}, {'type': 'EXPERIMENTAL', 'label': 'Substudy: Cohort 2b', 'description': 'Participants who received an updated PDS implant, have \\< 48 weeks post-re-implantation follow-up and one refill exchange visit in the main study, regardless of whether the refill exchange was administered or the visit was missed, will undergo one refill-exchange procedure (ranibizumab 100 mg/mL) Q24W, post main study re-implantation visit.', 'interventionNames': ['Drug: Ranibizumab refill exchange']}], 'interventions': [{'name': 'PDS Implant Pre-Filled with 100 mg/mL Ranibizumab', 'type': 'DRUG', 'description': 'Will be administered as per the schedule described in individual arm.', 'armGroupLabels': ['PDS Arm', 'Substudy: Cohort 1']}, {'name': 'Intravitreal Ranibizumab 0.5 mg Injection', 'type': 'DRUG', 'description': 'Will be administered as per the schedule described in individual arm.', 'armGroupLabels': ['Intravitreal Arm']}, {'name': 'Ranibizumab refill exchange', 'type': 'DRUG', 'description': 'Will be administered as per the schedule described in individual arm.', 'armGroupLabels': ['Intravitreal Arm', 'PDS Arm', 'Substudy: Cohort 1', 'Substudy: Cohort 2a', 'Substudy: Cohort 2b']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85206', 'city': 'Mesa', 'state': 'Arizona', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Barnet Dulaney Perkins Eye Center', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '85014', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Retinal Consultants of Arizona;Opthalmology', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85016', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Arizona Retina and Vitreous Consultants', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85020', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Associated Retina Consultants', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '93309', 'city': 'Bakersfield', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'California Retina Consultants', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Retina-Vitreous Associates Medical Group', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '91436', 'city': 'Encino', 'state': 'California', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'The Retina Partners', 'geoPoint': {'lat': 34.15917, 'lon': -118.50119}}, {'zip': '92835', 'city': 'Fullerton', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Retina Consultants of Orange County;Clinical Research', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Jules Stein Eye Institute/ UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94040', 'city': 'Mountain View', 'state': 'California', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Northern California Retina-Vitreous Associates', 'geoPoint': {'lat': 37.38605, 'lon': -122.08385}}, {'zip': '94609', 'city': 'Oakland', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'East Bay Retina Consultants', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '91105', 'city': 'Pasadena', 'state': 'California', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Doheny Eye Institute', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'zip': '91107', 'city': 'Pasadena', 'state': 'California', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'California Eye Specialists Medical Group', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'zip': '95841', 'city': 'Sacramento', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Retina Consultants Medical Group', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '94110', 'city': 'San Francisco', 'state': 'California', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Zuckerberg San Francisco General Hospital and Trauma Center', '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': '93103', 'city': 'Santa Barbara', 'state': 'California', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'California Retina Consultants;Research Department', 'geoPoint': {'lat': 34.42083, 'lon': -119.69819}}, {'zip': '80528', 'city': 'Fort Collins', 'state': 'Colorado', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Eye Center of Northern Colorado', 'geoPoint': {'lat': 40.58526, 'lon': -105.08442}}, {'zip': '80228', 'city': 'Lakewood', 'state': 'Colorado', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Colorado Clinical Research', 'geoPoint': {'lat': 39.70471, 'lon': -105.08137}}, {'zip': '06385', 'city': 'Waterford', 'state': 'Connecticut', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Retina Group of New England', 'geoPoint': {'lat': 41.3417, 'lon': -72.13597}}, {'zip': '33308', 'city': 'Fort Lauderdale', 'state': 'Florida', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Retina Group of Florida', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33912', 'city': 'Fort Myers', 'state': 'Florida', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'National Ophthalmic Research Institute', 'geoPoint': {'lat': 26.62168, 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