First in Human Study to Evaluate the Safety and Tolerability of GEM103 in Geographic Atrophy Secondary to Dry Age Related Macular Degeneration
NCT ID: NCT04246866
Last Updated: 2021-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
12 participants
INTERVENTIONAL
2019-12-19
2020-10-21
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose 1
A single dose of GEM103 will be administered via intravitreal injection. This arm will be the lowest dose of GEM103
GEM103
GEM103
Dose 2
A single dose of GEM103 will be administered via intravitreal injection. This arm will be the medium dose of GEM103
GEM103
GEM103
Dose 3
A single dose of GEM103 will be administered via intravitreal injection. This arm will be a higher dose of GEM103
GEM103
GEM103
Dose 4
A single dose of GEM103 will be administered via intravitreal injection. This arm will be the highest (extension) dose of GEM103
GEM103
GEM103
Interventions
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GEM103
GEM103
Eligibility Criteria
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Inclusion Criteria
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
* 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
50 Years
ALL
No
Sponsors
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Gemini Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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References
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Khanani AM, Maturi RK, Bagheri N, Bakall B, Boyer DS, Couvillion SS, Dhoot DS, Holekamp NM, Jamal KN, Marcus DM, Pieramici D, Aziz AA, Patki KC, Bridges WZ Jr, Barone SB. A Phase I, Single Ascending Dose Study of GEM103 (Recombinant Human Complement Factor H) in Patients with Geographic Atrophy. Ophthalmol Sci. 2022 Apr 11;2(2):100154. doi: 10.1016/j.xops.2022.100154. eCollection 2022 Jun.
Other Identifiers
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GEM-CL-10301
Identifier Type: -
Identifier Source: org_study_id
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