Ignite Creation Date:
2025-12-24 @ 11:50 AM
Ignite Modification Date:
2026-01-08 @ 8:27 AM
Study NCT ID:
NCT04656561
Status:
COMPLETED
Last Update Posted:
2024-08-21
First Post:
2020-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Investigating the Efficacy and Safety of Intravitreal Injections of ANX007 in Patients With Geographic Atrophy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057092', 'term': 'Geographic Atrophy'}], 'ancestors': [{'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 270}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-20', 'studyFirstSubmitDate': '2020-12-01', 'studyFirstSubmitQcDate': '2020-12-01', 'lastUpdatePostDateStruct': {'date': '2024-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'GA lesion growth rate', 'timeFrame': 'Baseline to Month 12', 'description': 'Change in GA lesion area as assessed by fundus autofluorescence (FAF)'}], 'secondaryOutcomes': [{'measure': 'Safety: Participants with treatment-emergent adverse events (TEAEs)', 'timeFrame': 'Baseline to Month 18', 'description': 'Number of participants with TEAEs'}, {'measure': 'Best corrected visual acuity (BCVA)', 'timeFrame': 'Baseline to Month 18', 'description': 'Change from baseline in BCVA as assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) test chart'}, {'measure': 'Low-luminance BCVA (LL-BCVA)', 'timeFrame': 'Baseline to Month 18', 'description': 'Change from baseline in LL-BCVA'}, {'measure': 'Low-luminance visual acuity deficit (LL-VD)', 'timeFrame': 'Baseline to Month 18', 'description': 'Change from baseline in LL-VD'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Geographic Atrophy']}, 'referencesModule': {'references': [{'pmid': '37314061', 'type': 'DERIVED', 'citation': 'Tzoumas N, Riding G, Williams MA, Steel DH. Complement inhibitors for age-related macular degeneration. Cochrane Database Syst Rev. 2023 Jun 14;6(6):CD009300. doi: 10.1002/14651858.CD009300.pub3.'}]}, 'descriptionModule': {'briefSummary': 'This study is being conducted in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) to determine if intravitreal (IVT) injections of ANX007 reduce GA lesion growth rate. The results will be used to guide further development of ANX007 in participants with geographic atrophy. The total duration of participation is expected to be approximately 19 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of geographic atrophy of the macula secondary to age-related macular degeneration as determined by the Investigator and confirmed by the Central Reading Center.\n* GA lesion must have the following characteristics as determined by the independent Central Reading Center based on assessment of FAF imaging at screening:\n\n 1. Well-demarcated GA with a total area (baseline lesion size) ≥2.5 millimeter squared (mm\\^2) and ≤17.5 mm\\^2.\n 2. If GA is multifocal, at least 1 focal lesion must measure ≥1.25 mm\\^2 with the overall aggregate area of GA as specified above.\n 3. Presence of hyper autofluorescence, any pattern, in the junctional zone of the GA. Absence of hyper autofluorescence (that is, pattern = none) is exclusionary.\n 4. The entire GA lesion must be completely visualized on the macula centered image and must be able to be imaged in its entirety and not contiguous with any peripapillary atrophy.\n* Normal luminance BCVA of 24 to 83 letters, inclusive, using ETDRS charts (20/25 to 20/320 Snellen equivalent, inclusive).\n* A female participant is eligible if she is not pregnant or breastfeeding and is a woman of non-childbearing potential or is using a contraceptive method that is highly effective, with a failure rate of \\<1% during the study intervention period and for at least 30 days after the last dose of study intervention.\n\nExclusion Criteria:\n\n* Geographic atrophy due to other causes than AMD such as Stargardt disease, cone-rod dystrophy, pathologic myopia, or toxic maculopathies (for example, plaquenil maculopathy) in either eye.\n* Any evidence of choroidal neovascularization (CNV) in the study eye:\n\n 1. Any history of CNV of any cause based on medical history.\n 2. Evidence of prior or active CNV or related findings (for example, retinal pigment epithelial rips or tears) based on FAF, Spectral Domain Optical Coherence Tomography (SD-OCT) imaging, intravenous fluorescein angiography (IVFA) and color fundus photo as assessed by the Central Reading Center.\n* Spherical equivalent of -8.00 diopters (D) myopia or higher in the study eye.\n* Uncontrolled glaucoma in the study eye (Intraocular pressure \\[IOP\\] \\>25 mmHg despite treatment with anti- glaucoma medication) or history of neovascular glaucoma.\n* History of glaucoma filtration surgery, minimally-invasive glaucoma surgery involving an implant, or vitrectomy surgery, or other procedure in the study eye that could affect drug distribution and/or clearance.\n* Any current or prior ocular disease, other than geographic atrophy, that in the opinion of the Investigator could interfere with the conduct of the study including, but not limited to, insufficient pupil dilation, retinal or optic nerve disease, media opacity, or aphakia in the study eye.\n* History of any prior IVT treatment for any indication in the study eye.\n* Any prior treatment for AMD in the study eye (for example, surgical, radiation, thermotherapeutic, or laser intervention), except oral supplements or minerals.'}, 'identificationModule': {'nctId': 'NCT04656561', 'acronym': 'ARCHER', 'briefTitle': 'A Study Investigating the Efficacy and Safety of Intravitreal Injections of ANX007 in Patients With Geographic Atrophy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Annexon, Inc.'}, 'officialTitle': 'A Phase 2, Multicenter, Randomized, Parallel-Group, Double-Masked, 4-Arm, Sham-Controlled Study of the Efficacy, Safety, and Tolerability of ANX007 Administered by Intravitreal Injection in Patients With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD) - The ARCHER Study', 'orgStudyIdInfo': {'id': 'ANX007-GA-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ANX007 Group 1', 'description': 'ANX007 administered every month', 'interventionNames': ['Drug: ANX007']}, {'type': 'EXPERIMENTAL', 'label': 'ANX007 Group 2', 'description': 'ANX007 administered every other month', 'interventionNames': ['Drug: ANX007']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Group 3', 'description': 'Sham injection administered every month', 'interventionNames': ['Other: Sham comparator']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Group 4', 'description': 'Sham injection administered every other month', 'interventionNames': ['Other: Sham comparator']}], 'interventions': [{'name': 'ANX007', 'type': 'DRUG', 'description': 'Form: solution for injection; Route of Administration: IVT', 'armGroupLabels': ['ANX007 Group 1', 'ANX007 Group 2']}, {'name': 'Sham comparator', 'type': 'OTHER', 'description': 'Form and Route of Administration: pressure to mimic IVT injection', 'armGroupLabels': ['Sham Group 3', 'Sham Group 4']}]}, 'contactsLocationsModule': 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