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

• Status: Active, not recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to investigate the safety and tolerability of GEM103 IVT injection + standard of care vs. sham + standard of care.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gemini Therapeutics, Inc.

Criteria

Inclusion Criteria:

1. At least 50 years old at the time of signed informed consent

a. CNV related to nAMD, with maximum CNV lesion size is 12 disc area and subretinal hemorrhage ≤50% of lesion size

2. On aflibercept treatment at enrollment

3. BCVA in the study eye of 24 to 75 letters using the ETDRS Chart VA Scale (approximately equivalent to Snellen VA of between 20/32 and 20/320)

Exclusion Criteria:

1. Presence of the following ocular conditions in the study eye:

1. Any active ocular disease or condition that could confound the assessment of the macula or be a contraindication to IVT injection, severe glaucoma, ocular infection of any nature, diabetic retinopathy graded as moderate nonproliferative diabetic retinopathy or worse (with or without diabetic macular edema)

2. Any intraocular surgery,

3. Aphakia or complete absence of the posterior capsule

4. Prior corneal transplant

5. Scar or fibrosis ≥50% of lesion or involving center of fovea

2. Presence of any of the following ocular conditions - in either eye:

1. History of herpetic infection, idiopathic polypoidal choroidal vasculopathy (PCV), pathologic myopia, central serous chorioretinopathy (CSCR), adult onset foveal pattern dystrophy

2. Concurrent disease that could require medical or surgical intervention during the study period

3. Active/suspected ocular/periocular infection or active intraocular inflammation

4. History of idiopathic or autoimmune-associated uveitis

3. Subject has experienced a cardiovascular or cerebrovascular event within 12 months of informed consent

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. Adeno- associated virus) or ocular device implantation (other than posterior chamber intraocular lens placement after cataract surgery)