A Multicenter, Multiple-Dose Study in Neovascular Age-related Macular Degeneration (nAMD) to Evaluate the Safety, Tolerability, Pharmacodynamics, Immunogenicity, and Clinical Effect of Repeat Intravitreal (IVT) Injections of GEM103 as an Adjunct to Standard of Care Aflibercept Therapy

GEM-CL-10311

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

2020-12-29

2022-01-10

2022-02-18

Terminated

Early phase I

50

Inclusion Criteria: 1. At least 50 years old at the time of signed informed consent 2. Choroidal neovascularization (CNV) related to nAMD with the following features, as determined by the Image Reading Center 1. Maximum CNV lesion size of 12 disc areas 2. Subretinal hemorrhage less than or equal to (\<=) 50% of lesion size 3. On aflibercept treatment prior to Day 1 4. Best Corrected Visual Acuity (BCVA) in the study eye between 24 to 75 letters using EDTRS Exclusion Criteria: 1. Presence of the following ocular conditions in the study eye: 1. Any active ocular disease or condition that impact the subject to participate in the study or be a contraindication of IVT injections 2. Any intraocular surgery 3. Aphakia or complete absence of the posterior capsule 4. Prior corneal transplant 5. Scar or fibrosis greater than or equal to (\>=) 50% of CNV 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. Any prior or ongoing medical condition or clinically significant screening laboratory value that may present a safety risk, interfere with study compliance, interfere with consistent study follow-up, or confound data interpretation throughout the longitudinal follow-up period 4. Has experienced a cardiovascular or cerebrovascular event within 12 months of informed consent 5. Females must not be pregnant or lactating 6. Current use of medications known to be toxic to the lens, retina or optic nerve 7. Use of any investigational new drug or other experimental treatment in the last 6 months prior to Day 1, and/or receipt of any prior gene therapy or ocular device implantation

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 50, 'type': 'ACTUAL'}}

2022-10-31