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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04246866
Other study ID # GEM-CL-10301
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date December 19, 2019
Est. completion date October 21, 2020

Study information

Verified date February 2021
Source Gemini Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

This is a Phase 1, multicenter, open-label, single-dose, dose-escalation study in subjects with GA secondary to dry AMD to investigate the safety, tolerability, pharmacodynamics (PD), and immunogenicity of IVT injections of GEM103 to a single eye. The study is designed to identify the MTD for IVT administration of GEM103. Safety and tolerability of a single dose of GEM103 will be assessed based on the occurrence of DLTs. Three escalating dose cohorts are planned. Subjects will undergo clinical and ophthalmic assessments for inclusion eligibility into the study. Enrolled subjects will receive GEM103 and be followed for safety, PK, clinical, and biomarker evaluations.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
GEM103
GEM103

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Gemini Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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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