A Multiple Dose Study of AVD-104 for Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD) (SIGLEC)
Geographic Atrophy of the Macula, Macular Degeneration
About this trial
This is an interventional treatment trial for Geographic Atrophy of the Macula focused on measuring Age-related Macular Degeneration, Geographic Atrophy, Dry AMD
Eligibility Criteria
Inclusion Criteria: Part 1: BCVA in the study eye using ETDRS Chart Visual Acuity Scale (VAS) of 5 to 55 letters (equivalent to Snellen VA of approximately 20/800 - 20/80) If GA is multifocal, at least one focal lesion must be ≥ 1.25 mm2 (0.5 DA) GA may be center involved. Part 2: BCVA in the study eye using ETDRS Chart VAS of 24 letters or better (equivalent to Snellen VA of 20/320 or better) Confirmed diagnosis of AMD that is non-center involving (i.e., non-sub-foveal) GA in 75% of participants. Center involvement allowed in 25% of participants. 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 areas of peripapillary atrophy. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: Part 1 and 2 - Presence of the following ocular conditions - in the Study Eye: Exudative AMD or choroidal neovascularization (CNV), including any evidence of retinal pigment epithelium rips or evidence of neovascularization anywhere based on spectral domain optical coherence tomography (SD-OCT) imaging and/or fluorescein angiography as assessed by the Reading Center. Any ocular condition other than GA secondary to AMD that may require surgery or medical intervention during the study period or, in the opinion of the Investigator, could compromise visual function during the study period.
Sites / Locations
- Retina Vitreous Associates of FloridaRecruiting
- Midwest Eye InstituteRecruiting
- Cumberland Valley Retina ConsultantsRecruiting
- Retina Research Institute of TexasRecruiting
- Texas Retina AssociatesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Active Comparator
Active Comparator
Sham Comparator
Active Comparator
Part 1
Part 2: High dose AVD-104
Part 2: Low dose AVD-104
Part 2: Sham
Part 2: Avacincaptad
Participants will receive a single intravitreal injection of AVD-104 at one of 4 escalating doses. All participants will be followed up for safety until Month 3. Participants from Part 1 will be offered the opportunity to receive monthly injections of high dose AVD-104 once the 6-month timepoint has been reached for 50% of the participants in Part 2. These participants will be followed for safety only.
82 participants will be randomized and treated with bimonthly intravitreal injections of high-dose AVD-104 for the first 12 months. They will continue monthly injections for months 13-24.
82 participants will be randomized and treated with monthly intravitreal injections of low dose AVD-104 for 24 months.
82 participants will be randomized to receive sham injections monthly for 24 months
41 participants will be randomized to receive monthly injections of avacincaptad (2 mg. intravitreal)