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TERMINATEDPHASE2

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

A Multicenter, Open-label, Multiple Dose Study in Patients With Geographic Atrophy Secondary to Dry Age-related Macular Degeneration to Evaluate the Safety, Tolerability, Pharmacodynamics, and Immunogenicity of Repeat Intravitreal Injections of GEM103

NCT04643886•Gemini Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

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

Detailed Description

This is a Phase 2a, multi-center, open-label, multiple dose study in subjects with geographic atrophy (GA) secondary to dry Age-related Macular Degeneration (dry AMD) to investigate the safety, PK/PD, biomarker and early clinical effect of GEM103 repeat IVT injections. Subjects will undergo clinical and ophthalmic assessments for determination of inclusion in the study. Subjects who participated in the Phase 1 Study (GEM-CL-10301) as well as treatment naïve subjects that did not participate in the GEM-CL-10301 Study and who meet all eligibility criteria will be enrolled.

Eligibility

Age

50 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. At least 50 years old at the time of signed informed consent.
•2. Must have one of the following genetic profiles:
•1. Genetic Profile A.
•2. Genetic Profile B.
•3. 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).
•4. 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.
•5. Sufficiently clear ocular media and able to cooperate with ophthalmic visual function testing and anatomic assessment in the study eye.
•6. 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.

Exclusion Criteria

•1. Presence of the following ocular conditions - in the study eye:
•1. Any history of exudative Age-related Macular Degeneration or choroidal neovascularization.
•2. Any active ocular disease or condition that could confound the assessment of the macula or be a contraindication to IVT injection.
•3. Any intraocular surgery, with the exception of stable intraocular lens replacement surgery more than 3 months prior to consent.
•4. Aphakia or complete absence of the posterior capsule.
•5. History of laser therapy to the macula or fundus or extensive laser to the retina.
•6. Prior corneal transplant.
•2. Presence of any of the following ocular conditions - in either eye:
•1. History of herpetic infection.
•2. Concurrent disease that could require medical or surgical intervention during the study period.
+8 more criteria

Locations (29)

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

Key Dates

Start Date

July 30, 2020

Primary Completion Date

February 18, 2022

Completion Date

March 21, 2022

Last Updated

September 23, 2022

Enrollment

ACTUAL participants

Conditions

Dry Age-related Macular DegenerationGeographic AtrophyMacular DegenerationRetinal DiseaseRetinal Degeneration

Interventions

GEM103

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 23, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Direct Discrimination of Quantum States by the Human Eye

Real-World Evaluation of AI Enabled Multi-Spectral Imaging (MSI) for AMD Biomarker Detection

A Study to Learn How Avacincaptad Pegol (Izervay™) is Used in Clinical Practice in People Who Have Geographic Atrophy

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