A Multiple Dose Study of Repeat Intravitreal Injections of GEM103 in Neovascular Age-related Macular Degeneration
Condition: Neovascular Age-related Macular Degeneration; Retinal Disease; Retinal Degeneration; Macular Degeneration
MeSH terms: Macular Degeneration; Wet Macular Degeneration; Retinal Diseases; Retinal Degeneration
Intervention: GEM103; Aflibercept; Sham
Intervention description: GEM103 500 mcg/50 mcL intravitreal injection; Aflibercept 2 mg/50 mcL (SOC) intravitreal injection
Sham intravitreal injection; Sham intravitreal injection
Intervention MeSH terms: Aflibercept
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 50.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

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

Eligibility criteria:

        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