First in Human Study to Evaluate the Safety and Tolerability of GEM103 in Geographic Atrophy Secondary to Dry Age Related Macular Degeneration

Completed · Phase 1

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

In brief

The study is designed to identify the maximum tolerated dose (MTD) for intravitreal (IVT) administration of GEM103 in subjects with geographic atrophy (GA) secondary to dry AMD. Safety and tolerability of a single dose of GEM103 will be assessed based on the occurrence of dose-limiting toxicities (DLTs). Each subject will be followed for safety, pharmacokinetic (PK), clinical, and biomarker evaluations. Three escalating dose cohorts are planned.

Key facts

Study ID

NCT04246866

Run by

Gemini Therapeutics, Inc.

People needed

12

Starts

2019-12-19

Expected to finish

2020-10-21

Last updated by the study team

2021-02-11

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
• Able to cooperate sufficiently for adequate ophthalmic visual function testing and anatomic assessment and provide informed consent prior to initiation of any study procedure
• Best corrected visual acuity (BCVA) in study eye between 5-45 letters
• Confirmed diagnosis of central GA in the study eye and eligible total GA lesion size

You may not qualify if…

• Presence of the following ocular conditions - in the study eye:
• Exudative AMD or choroidal neovascularization (CNV)
• Any ocular disease or condition that could impact the subject's ability to participate in the study or be a contraindication to IVT injection
• Any intraocular surgery (with the exception of intraocular lens replacement surgery more than 3 months prior to consent)
• Presence of any of the following ocular conditions - in either eye:
• History of herpetic infection
• Ongoing treatment with antiangiogenic therapies in the fellow eye or completed treatment in the study eye
• 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, interfere with consistent study follow-up, or confound data interpretation throughout the longitudinal follow-up period
• Female subjects must not be pregnant or lactating
• Current use of medications known to be toxic to the lens, retina, or optic nerve

Where it is running

• Associated Retina Consultants — Phoenix, Arizona, United States
• Retinal Consultants of Arizona — Phoenix, Arizona, United States
• California Retina Consultants — Bakersfield, California, United States
• Retina Vitreous Associates — Beverly Hills, California, United States
• California Retina Consultants — Oxnard, California, United States
• California Retina Consultants — Santa Barbara, California, United States
• California Retina Consultants — Santa Maria, California, United States
• Southeast Retina Center — Augusta, Georgia, United States
• Midwest Eye Institute — Indianapolis, Indiana, United States
• Pepose Vision Institute — Chesterfield, Missouri, United States
• Sierra Eye Associates — Reno, Nevada, United States
• Western Carolina Retinal Associates — Asheville, North Carolina, United States

Full record on ClinicalTrials.gov

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