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

Gemini Therapeutics

Status and phase: Terminated; Phase 2

Conditions: Macular Degeneration; Retinal Degeneration; Neovascular Age-related Macular Degeneration; Retinal Disease

Treatments: Drug: Sham; Drug: Aflibercept; Biological: GEM103

Study type: Interventional

Funder types: Industry

Identifiers

NCT04684394

GEM-CL-10311

Details and patient eligibility

About

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

Full description

This is a Phase 2a, multi-center, multiple dose study in subjects with Neovascular Age-related Macular Degeneration (nAMD) to investigate the safety and tolerability of GEM103 IVT injection + standard of care vs. sham + standard of care.

Subjects will undergo clinical and ophthalmic assessments for determination of inclusion in the study and who meet all eligibility criteria will be enrolled.

Enrollment: 50 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

SoC + GEM103

Experimental group

Description:

Participants were administered SoC therapy defined as aflibercept (2 milligram \[mg\]/50 microliter \[mcL\]) first, followed by GEM103 (500 microgram \[mcg\]/50mcL) 15 minutes later. Administration occurred every other month (EOM) for a total of 6 doses during the 12-month study period.

Treatment:

Drug: Aflibercept

Biological: GEM103

SoC + Sham

Sham Comparator group

Description:

Participants were administered SoC therapy defined as aflibercept (2mg/50mcL) first, followed by the Sham injection 15 minutes later. Administration occurred EOM for a total of 6 doses during the 12-month study period.

Treatment:

Drug: Sham

Drug: Aflibercept