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

Stopped early · Phase 2

Conditions studied: Dry Age-related Macular Degeneration, Geographic Atrophy, Macular Degeneration, Retinal Disease, Retinal Degeneration

In brief

This study is designed to investigate the safety, PK/PD, biomarker and early clinical effects of repeat GEM103 IVT injections.

Key facts

Study ID

NCT04643886

Run by

Gemini Therapeutics, Inc.

People needed

62

Starts

2020-07-30

Expected to finish

2022-03-21

Last updated by the study team

2022-09-23

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.
• Must have one of the following genetic profiles:
• Genetic Profile A.
• Genetic Profile B.
• BCVA in the study eye of 24 to 83 letters using ETDRS Chart Visual Acuity (VA) Scale (approximately equivalent to Snellen VA of 20/25 to 20/320).
• Confirmed diagnosis of GA in the study eye where total size of all GA lesions in the study eye must be within 0.5 to 15.01- and 7- disc areas.
• Sufficiently clear ocular media and able to cooperate with ophthalmic visual function testing and anatomic assessment in the study eye.
• Understands the full nature and purpose of the study and provides informed consent prior to initiation of any study procedure; all subjects with a reproductive potential must agree to use effective contraceptive methods through the end of study (EOS) Visit.

You may not qualify if…

• Presence of the following ocular conditions - in the study eye:
• Any history of exudative Age-related Macular Degeneration or choroidal neovascularization.
• Any active ocular disease or condition that could confound the assessment of the macula or be a contraindication to IVT injection.
• Any intraocular surgery, with the exception of stable intraocular lens replacement surgery more than 3 months prior to consent.
• Aphakia or complete absence of the posterior capsule.
• History of laser therapy to the macula or fundus or extensive laser to the retina.
• Prior corneal transplant.
• Presence of any of the following ocular conditions - in either eye:
• History of herpetic infection.
• Concurrent disease that could require medical or surgical intervention during the study period.
• Active uveitis and/or vitritis (grade: trace or above).
• History of idiopathic or autoimmune-associated uveitis.
• Active blepharitis, conjunctivitis, keratitis, episcleritis, scleritis, or endophthalmitis.
• Any ophthalmologic condition that reduces the clarity of the media and that, in the opinion of the Investigator, interferes with ophthalmologic examination.
• In the opinion of the Investigator, the subject has any prior or ongoing medical condition (e.g., ocular other than dry AMD, systemic, psychiatric) or clinically significant screening laboratory value that may present a safety risk, interfere with study compliance or study follow-up, or confound data interpretation throughout the follow-up period.
• Female subjects must not be pregnant or lactating, nor plan to become pregnant during the study.
• 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, and/or receipt of any prior gene therapy (e.g., AAV) or ocular device implantation (other than PCIOL placement following cataract surgery)

Where it is running

• Gemini Clinical Trial Site — Phoenix, Arizona, United States
• Gemini Clinical Trial Site — Bakersfield, California, United States
• Gemini Clinical Trial Site — Beverly Hills, California, United States
• Gemini Clinical Trial Site — Oxnard, California, United States
• Gemini Clinical Trial Site — Poway, California, United States
• Gemini Clinical Trial Site — Santa Barbara, California, United States
• Gemini Clinical Trial Site — Santa Maria, California, United States
• Gemini Clinical Trial Site — Golden, Colorado, United States
• Gemini Clinical Trial Site — New London, Connecticut, United States
• Gemini Clinical Trial Site — Palm Beach Gardens, Florida, United States
• Gemini Clinical Trial Site — St. Petersburg, Florida, United States
• Gemini Clinical Trial Site — Tallahassee, Florida, United States
• Gemini Clinical Trial Site — Winter Haven, Florida, United States
• Gemini Clinical Trial Site — Augusta, Georgia, United States
• Gemini Clinical Trial Site — Marietta, Georgia, United States
• Gemini Clinical Trial Site — Oak Park, Illinois, United States
• Gemini Clinical Trial Site — Indianapolis, Indiana, United States
• Gemini Clinical Trial Site — Chesterfield, Missouri, United States
• Gemini Clinical Trial Site — St Louis, Missouri, United States
• Gemini Clinical Trial Site — Reno, Nevada, United States
• Gemini Clinical Trial Site — Bloomfield, New Jersey, United States
• Gemini Clinical Trial Site — Asheville, North Carolina, United States
• Gemini Clinical Trial Site — Charlotte, North Carolina, United States
• Gemini Clinical Trial Site — Eugene, Oregon, United States
• Gemini Clinical Trial Site — Rapid City, South Dakota, United States

Full record on ClinicalTrials.gov

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