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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.
Full 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.
Enrollment
Sex
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Inclusion criteria
Part 1:
Part 2:
Exclusion criteria
Participants are excluded from the study if any of the following criteria apply:
Part 1 and 2
Primary purpose
Allocation
Interventional model
Masking
300 participants in 4 patient groups
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Central trial contact
David Callanan, MD; Keri Marchitto, MA
Data sourced from clinicaltrials.gov
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