Study Stopped
no further benefit
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
2 other identifiers
interventional
62
1 country
29
Brief Summary
This study is designed to investigate the safety, PK/PD, biomarker and early clinical effects of repeat GEM103 IVT injections.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2020
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 30, 2020
CompletedFirst Submitted
Initial submission to the registry
November 16, 2020
CompletedFirst Posted
Study publicly available on registry
November 25, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 18, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 21, 2022
CompletedSeptember 23, 2022
September 1, 2022
1.6 years
November 16, 2020
September 22, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Safety of intravitreal (IVT) injections of GEM103, as measured by number of subjects with ocular adverse events.
18 months
Secondary Outcomes (2)
To describe the clinical effect of GEM103 IVT injection, as the change from baseline in best corrected visual acuity (BCVA) scores as assessed by ETDRS scale.
6 months
To evaluate the total CFH levels in aqueous humor after GEM103 IVT injection, whenever possible.
6 months
Study Arms (2)
Cohort with Genetic Profile A
EXPERIMENTALSubjects will have Genetic Profile A. Intervention: Biological: GEM103.
Cohort with Genetic Profile B
EXPERIMENTALSubjects will have Genetic Profile B. Intervention: Biological: GEM103
Interventions
Eligibility Criteria
You may qualify if:
- At least 50 years old at the time of signed informed consent.
- Must have one of the following genetic profiles:
- Genetic Profile A.
- Genetic Profile B.
- 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).
- 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.
- Sufficiently clear ocular media and able to cooperate with ophthalmic visual function testing and anatomic assessment in the study eye.
- 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.
You may not qualify if:
- Presence of the following ocular conditions - in the study eye:
- Any history of exudative Age-related Macular Degeneration or choroidal neovascularization.
- Any active ocular disease or condition that could confound the assessment of the macula or be a contraindication to IVT injection.
- Any intraocular surgery, with the exception of stable intraocular lens replacement surgery more than 3 months prior to consent.
- Aphakia or complete absence of the posterior capsule.
- History of laser therapy to the macula or fundus or extensive laser to the retina.
- Prior corneal transplant.
- Presence of any of the following ocular conditions - in either eye:
- History of herpetic infection.
- Concurrent disease that could require medical or surgical intervention during the study period.
- Active uveitis and/or vitritis (grade: trace or above).
- History of idiopathic or autoimmune-associated uveitis.
- Active blepharitis, conjunctivitis, keratitis, episcleritis, scleritis, or endophthalmitis.
- Any ophthalmologic condition that reduces the clarity of the media and that, in the opinion of the Investigator, interferes with ophthalmologic examination.
- In the opinion of the Investigator, the subject has 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 or study follow-up, or confound data interpretation throughout the follow-up period.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
Gemini Clinical Trial Site
Phoenix, Arizona, 85020, United States
Gemini Clinical Trial Site
Bakersfield, California, 93309, United States
Gemini Clinical Trial Site
Beverly Hills, California, 90211, United States
Gemini Clinical Trial Site
Oxnard, California, 93036, United States
Gemini Clinical Trial Site
Poway, California, 92064, United States
Gemini Clinical Trial Site
Santa Barbara, California, 93103, United States
Gemini Clinical Trial Site
Santa Maria, California, 93454, United States
Gemini Clinical Trial Site
Golden, Colorado, 80401, United States
Gemini Clinical Trial Site
New London, Connecticut, 06320, United States
Gemini Clinical Trial Site
Palm Beach Gardens, Florida, 33410, United States
Gemini Clinical Trial Site
St. Petersburg, Florida, 33711, United States
Gemini Clinical Trial Site
Tallahassee, Florida, 32308, United States
Gemini Clinical Trial Site
Winter Haven, Florida, 33880, United States
Gemini Clinical Trial Site
Augusta, Georgia, 30909, United States
Gemini Clinical Trial Site
Marietta, Georgia, 30060, United States
Gemini Clinical Trial Site
Oak Park, Illinois, 60304, United States
Gemini Clinical Trial Site
Indianapolis, Indiana, 46290, United States
Gemini Clinical Trial Site
Chesterfield, Missouri, 63017, United States
Gemini Clinical Trial Site
St Louis, Missouri, 63144, United States
Gemini Clinical Trial Site
Reno, Nevada, 89502, United States
Gemini Clinical Trial Site
Bloomfield, New Jersey, 07003, United States
Gemini Clinical Trial Site
Asheville, North Carolina, 28803, United States
Gemini Clinical Trial Site
Charlotte, North Carolina, 28210, United States
Gemini Clinical Trial Site
Eugene, Oregon, 97401, United States
Gemini Clinical Trial Site
Rapid City, South Dakota, 57701, United States
Gemini Clinical Trial Site
Abilene, Texas, 79606, United States
Gemini Clinical Trial Site
Dallas, Texas, 75231, United States
Gemini Clinical Trial Site
The Woodlands, Texas, 77384, United States
Gemini Clinical Trial Site
Virginia Beach, Virginia, 23454, United States
Related Publications (1)
Tzoumas N, Riding G, Williams MA, Steel DH. Complement inhibitors for age-related macular degeneration. Cochrane Database Syst Rev. 2023 Jun 14;6(6):CD009300. doi: 10.1002/14651858.CD009300.pub3.
PMID: 37314061DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 16, 2020
First Posted
November 25, 2020
Study Start
July 30, 2020
Primary Completion
February 18, 2022
Study Completion
March 21, 2022
Last Updated
September 23, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share