Macular Degeneration Clinical Trial
Official title:
A Phase 1, Multicenter, Open-label, Single-dose, Dose-escalation Study in Patients With Geographic Atrophy (GA) Secondary to Dry Age-related Macular Degeneration (AMD) to Evaluate the Safety, Tolerability, Pharmacodynamics, and Immunogenicity of Intravitreal Injections of GEM103
Verified date | February 2021 |
Source | Gemini Therapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 12 |
Est. completion date | October 21, 2020 |
Est. primary completion date | October 21, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility | Inclusion Criteria: 1. At least 50 years old at the time of signed informed consent 2. Able to cooperate sufficiently for adequate ophthalmic visual function testing and anatomic assessment and provide informed consent prior to initiation of any study procedure 3. Best corrected visual acuity (BCVA) in study eye between 5-45 letters 4. Confirmed diagnosis of central GA in the study eye and eligible total GA lesion size Exclusion Criteria: 1. 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) 2. 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 3. 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 4. Female subjects must not be pregnant or lactating 5. Current use of medications known to be toxic to the lens, retina, or optic nerve |
Country | Name | City | State |
---|---|---|---|
United States | Western Carolina Retinal Associates | Asheville | North Carolina |
United States | Southeast Retina Center | Augusta | Georgia |
United States | California Retina Consultants | Bakersfield | California |
United States | Retina Vitreous Associates | Beverly Hills | California |
United States | Pepose Vision Institute | Chesterfield | Missouri |
United States | Midwest Eye Institute | Indianapolis | Indiana |
United States | California Retina Consultants | Oxnard | California |
United States | Associated Retina Consultants | Phoenix | Arizona |
United States | Retinal Consultants of Arizona | Phoenix | Arizona |
United States | Sierra Eye Associates | Reno | Nevada |
United States | California Retina Consultants | Santa Barbara | California |
United States | California Retina Consultants | Santa Maria | California |
Lead Sponsor | Collaborator |
---|---|
Gemini Therapeutics, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change from baseline in aqueous humor biomarker levels (in ng/mL) of complement factors | Up to 8 Weeks | ||
Other | Change from baseline in clinical assessments including BCVA and LLVA scores as assessed by ETDRS Visual Acuity Score in number of letters | Up to 8 Weeks | ||
Other | Change from baseline in clinical assessments including area of GA in mm2 as assessed by fundus imaging | Up to 8 Weeks | ||
Other | Change in concentration of GEM103 in blood samples | Up to 8 Weeks | ||
Primary | Incidence and severity of AEs/SAEs following drug administration | Up to 8 Weeks | ||
Secondary | GEM103 concentrations in ocular fluids | Up to 8 Weeks | ||
Secondary | Changes in complement factor levels compared to baseline after drug administration | Up to 8 Weeks |
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