A Multiple Dose Study of Repeat Intravitreal Injections of GEM103 in Dry Age-related Macular Degeneration

Exclusion Criteria

• •1. Presence of the following ocular conditions - in the study eye:
• •1. Any history of exudative Age-related Macular Degeneration or choroidal neovascularization.
• •2. Any active ocular disease or condition that could confound the assessment of the macula or be a contraindication to IVT injection.
• •3. Any intraocular surgery, with the exception of stable intraocular lens replacement surgery more than 3 months prior to consent.
• •4. Aphakia or complete absence of the posterior capsule.
• •5. History of laser therapy to the macula or fundus or extensive laser to the retina.
• •6. Prior corneal transplant.
• •2. Presence of any of the following ocular conditions - in either eye:
• •1. History of herpetic infection.
• •2. Concurrent disease that could require medical or surgical intervention during the study period.
• •3. Active uveitis and/or vitritis (grade: trace or above).
• •4. History of idiopathic or autoimmune-associated uveitis.
• •5. Active blepharitis, conjunctivitis, keratitis, episcleritis, scleritis, or endophthalmitis.
• •6. Any ophthalmologic condition that reduces the clarity of the media and that, in the opinion of the Investigator, interferes with ophthalmologic examination.
• •3. In the opinion of the Investigator, the subject has any prior or ongoing medical condition (e.g., ocular other than dry AMD, systemic, psychiatric) or clinically significant screening laboratory value that may present a safety risk, interfere with study compliance or study follow-up, or confound data interpretation throughout the follow-up period.
• •4. Female subjects must not be pregnant or lactating, nor plan to become pregnant during the study.
• •5. Current use of medications known to be toxic to the lens, retina, or optic nerve.
• •6. Use of any investigational new drug or other experimental treatment in the last 6 months, and/or receipt of any prior gene therapy (e.g., AAV) or ocular device implantation (other than PCIOL placement following cataract surgery)