Geographic Atrophy of the Macula, Macular Degeneration
Conditions
Keywords
Age-related Macular Degeneration, Geographic Atrophy, Dry AMD
Brief summary
Investigate the Safety, Pharmacokinetics, and Treatment effects of Single and Multi-dose of Intravitreal AVD-104 in participants with geographic atrophy secondary to age-related macular degeneration.
Detailed description
Part 1 of the trial will be a multi-center, open label safety and dose escalation study with a potential enrollment of 30 participants having geographic atrophy (GA) secondary to macular degeneration. They will receive a single intravitreal injection of study drug (AVD-104) and will be followed for 3 months for safety observation. They will have both aqueous humor and peripheral blood drawn for pharmacokinetic and pharmacodynamic evaluations. Part 2 will be a multi-center, double masked, randomized trial to evaluate the treatment effect of AVD-104 on participants with geographic atrophy secondary to macular degeneration. Participants will be randomized to high dose AVD-104, low dose AVD-104, or active comparator (avacincaptad). The primary endpoint will be the difference in the rate of growth of the GA area as measured by fundus autofluorescence.
Interventions
DRUGAVD-104
Intravitreal injection
DRUGAvacincaptad
Intravitreal injection of 2 mg avacincaptad
Sponsors
Aviceda Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Part 2 - Double Masked, Randomized, Multi-Center
Intervention model description
Part 1 - Open Label, Multi-Center, Dose Escalation
Eligibility
Sex/Gender
ALL
Age
55 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
Part 1: 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) 2. If GA is multifocal, at least one focal lesion must be ≥ 1.25 mm2 (0.5 DA) 3. GA may be center involved. Part 2: 1. BCVA in the study eye using ETDRS Chart VAS of 24 letters or better (equivalent to Snellen VA of 20/320 or better) 2. Confirmed diagnosis of AMD that is non-center involving (i.e., non-sub-foveal) GA in 50% of participants. Center involvement allowed in 50% of participants. 3. 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: 1. 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. 2. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Dose Limiting Toxicity in Part 1 | 3 months | The number of participants experiencing a dose limiting toxicity corresponding to a category of 3 or greater on the National Cancer Institute Common Terminology Criteria for Adverse Events |
| The Rate of Change in Area of Geographic Atrophy at Month 12 in Participants in Part 2 | 12 months | The rate of change from baseline in area of GA as measured by fundus autofluorescence at month 12. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prevention of Vision Loss from Baseline in Participants in Part 2 | 12 months | Proportion of participants with 15 or greater letter loss in best corrected visual acuity (BCVA) (assessed with the Early Treatment Diabetic Retinopathy Study \[ETDRS\] visual acuity). |
Countries
United States
Contacts
STUDY_DIRECTORDavid Callanan, MD
Aviceda Therapeutics
Outcome results
None listed