A Study Investigating the Efficacy and Safety of Intravitreal Injections of ANX007 in Patients With Geographic Atrophy
- Conditions
- Geographic Atrophy
- Registration Number
- NCT04656561
- Lead Sponsor
- Annexon, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Diagnosis of geographic atrophy of the macula secondary to age-related macular<br> degeneration as determined by the Investigator and confirmed by the Central Reading<br> Center.<br><br> - GA lesion must have the following characteristics as determined by the independent<br> Central Reading Center based on assessment of FAF imaging at screening:<br><br> 1. Well-demarcated GA with a total area (baseline lesion size) =2.5 millimeter<br> squared (mm^2) and =17.5 mm^2.<br><br> 2. If GA is multifocal, at least 1 focal lesion must measure =1.25 mm^2 with the<br> overall aggregate area of GA as specified above.<br><br> 3. Presence of hyper autofluorescence, any pattern, in the junctional zone of the<br> GA. Absence of hyper autofluorescence (that is, pattern = none) is<br> exclusionary.<br><br> 4. The entire GA lesion must be completely visualized on the macula centered image<br> and must be able to be imaged in its entirety and not contiguous with any<br> peripapillary atrophy.<br><br> - Normal luminance BCVA of 24 to 83 letters, inclusive, using ETDRS charts (20/25 to<br> 20/320 Snellen equivalent, inclusive).<br><br> - A female participant is eligible if she is not pregnant or breastfeeding and is a<br> woman of non-childbearing potential or is using a contraceptive method that is<br> highly effective, with a failure rate of <1% during the study intervention period<br> and for at least 30 days after the last dose of study intervention.<br><br>Exclusion Criteria:<br><br> - Geographic atrophy due to other causes than AMD such as Stargardt disease, cone-rod<br> dystrophy, pathologic myopia, or toxic maculopathies (for example, plaquenil<br> maculopathy) in either eye.<br><br> - Any evidence of choroidal neovascularization (CNV) in the study eye:<br><br> 1. Any history of CNV of any cause based on medical history.<br><br> 2. Evidence of prior or active CNV or related findings (for example, retinal<br> pigment epithelial rips or tears) based on FAF, Spectral Domain Optical<br> Coherence Tomography (SD-OCT) imaging, intravenous fluorescein angiography<br> (IVFA) and color fundus photo as assessed by the Central Reading Center.<br><br> - Spherical equivalent of -8.00 diopters (D) myopia or higher in the study eye.<br><br> - Uncontrolled glaucoma in the study eye (Intraocular pressure [IOP] >25 mmHg despite<br> treatment with anti- glaucoma medication) or history of neovascular glaucoma.<br><br> - History of glaucoma filtration surgery, minimally-invasive glaucoma surgery<br> involving an implant, or vitrectomy surgery, or other procedure in the study eye<br> that could affect drug distribution and/or clearance.<br><br> - Any current or prior ocular disease, other than geographic atrophy, that in the<br> opinion of the Investigator could interfere with the conduct of the study including,<br> but not limited to, insufficient pupil dilation, retinal or optic nerve disease,<br> media opacity, or aphakia in the study eye.<br><br> - History of any prior IVT treatment for any indication in the study eye.<br><br> - Any prior treatment for AMD in the study eye (for example, surgical, radiation,<br> thermotherapeutic, or laser intervention), except oral supplements or minerals.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method GA lesion growth rate
- Secondary Outcome Measures
Name Time Method Safety: Participants with treatment-emergent adverse events (TEAEs);Best corrected visual acuity (BCVA);Low-luminance BCVA (LL-BCVA);Low-luminance visual acuity deficit (LL-VD)