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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Neovascular Age-related Macular Degeneration, Retinal Disease, Retinal Degeneration, Macular Degeneration

In brief

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

Key facts

Study ID

NCT04684394

Run by

Gemini Therapeutics, Inc.

People needed

50

Starts

2020-12-29

Expected to finish

2022-02-18

Last updated by the study team

2022-10-31

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• At least 50 years old at the time of signed informed consent
• Choroidal neovascularization (CNV) related to nAMD with the following features, as determined by the Image Reading Center
• Maximum CNV lesion size of 12 disc areas
• Subretinal hemorrhage less than or equal to (<=) 50% of lesion size
• On aflibercept treatment prior to Day 1
• Best Corrected Visual Acuity (BCVA) in the study eye between 24 to 75 letters using EDTRS

You may not qualify if…

• Presence of the following ocular conditions in the study eye:
• Any active ocular disease or condition that impact the subject to participate in the study or be a contraindication of IVT injections
• Any intraocular surgery
• Aphakia or complete absence of the posterior capsule
• Prior corneal transplant
• Scar or fibrosis greater than or equal to (>=) 50% of CNV lesion or involving center of fovea
• Presence of any of the following ocular conditions in either eye:
• History of herpetic infection, idiopathic polypoidal choroidal vasculopathy (PCV), pathologic myopia, central serous chorioretinopathy (CSCR), adult onset foveal pattern dystrophy
• Concurrent disease that could require medical or surgical intervention during the study period
• Active/suspected ocular/periocular infection or active intraocular inflammation
• History of idiopathic or autoimmune-associated uveitis
• 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
• Has experienced a cardiovascular or cerebrovascular event within 12 months of informed consent
• Females must not be pregnant or lactating
• Current use of medications known to be toxic to the lens, retina or optic nerve
• 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

Where it is running

• Gemini Clinical Trial Site 16 — Phoenix, Arizona, United States
• Gemini Clinical Trial Site 11 — Campbell, California, United States
• Gemini Clinical Trial Site 9 — Encino, California, United States
• Gemini Clinical Trial Site 17 — Huntington Beach, California, United States
• Gemini Clinical Trial Site 12 — Pasadena, California, United States
• Gemini Clinical Trial Site 5 — Miami, Florida, United States
• Gemini Clinical Trial Site 7 — Pinellas Park, Florida, United States
• Gemini Clinical Trial Site 20 — Sarasota, Florida, United States
• Gemini Clinical Trial Site 8 — Stuart, Florida, United States
• Gemini Clinical Trial Site 18 — Winter Haven, Florida, United States
• Gemini Clinical Trial Site 19 — Indianapolis, Indiana, United States
• Gemini Clinical Trial Site 4 — Hagerstown, Maryland, United States
• Gemini Clinical Trial Site 23 — Worcester, Massachusetts, United States
• Gemini Clinical Trial Site 22 — Royal Oak, Michigan, United States
• Gemini Clinical Trial Site 1 — Reno, Nevada, United States
• Gemini Clinical Trial Site 2 — Asheville, North Carolina, United States
• Gemini Clinical Trial Site 15 — Charlotte, North Carolina, United States
• Gemini Clinical Trial Site 6 — Cincinnati, Ohio, United States
• Gemini Clinical Trial Site 10 — Eugene, Oregon, United States
• Gemini Clinical Trial Site 13 — Beaufort, South Carolina, United States
• Gemini Clinical Trial Site 3 — Dallas, Texas, United States
• Gemini Clinical Trial Site 21 — San Antonio, Texas, United States
• Gemini Clinical Trial Site 14 — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.