Protocol Number: AVD-104-C01
Primary Investigator: Thomas Aaberg Jr., M.D.
Aviceda Therapeutics, Inc. has begun a study to 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.
Part 1 of the trial will be a multi-center, open label safety and dose escalation study with a potential enrollment of 24 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 sham in a 1:1:1 ratio. They will receive monthly injections of study drug for 12 months. The primary endpoint will be the difference in the rate of growth of the GA area between treated participants versus sham as measured by fundus autofluorescence.
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