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

Sponsor
Gemini Therapeutics, Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT04643886
Collaborator
(none)
62
Enrollment
29
Locations
2
Arms
19.7
Actual Duration (Months)
2.1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
62 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Jul 30, 2020
Actual Primary Completion Date :
Feb 18, 2022
Actual Study Completion Date :
Mar 21, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort with Genetic Profile A

Subjects will have Genetic Profile A. Intervention: Biological: GEM103.

Drug: GEM103
Biological
Experimental: Cohort with Genetic Profile B

Subjects will have Genetic Profile B. Intervention: Biological: GEM103

Drug: GEM103
Biological

Outcome Measures

Primary Outcome Measures

  1. Safety of intravitreal (IVT) injections of GEM103, as measured by number of subjects with ocular adverse events. [18 months]

Secondary Outcome Measures

  1. 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]

  2. To evaluate the total CFH levels in aqueous humor after GEM103 IVT injection, whenever possible. [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. At least 50 years old at the time of signed informed consent.

  2. Must have one of the following genetic profiles:

  3. Genetic Profile A.

  4. Genetic Profile B.

  5. 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).

  6. 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.

  7. Sufficiently clear ocular media and able to cooperate with ophthalmic visual function testing and anatomic assessment in the study eye.

  8. 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:

  2. Any history of exudative Age-related Macular Degeneration or choroidal neovascularization.

  3. Any active ocular disease or condition that could confound the assessment of the macula or be a contraindication to IVT injection.

  4. Any intraocular surgery, with the exception of stable intraocular lens replacement surgery more than 3 months prior to consent.

  5. Aphakia or complete absence of the posterior capsule.

  6. History of laser therapy to the macula or fundus or extensive laser to the retina.

  7. Prior corneal transplant.

  8. Presence of any of the following ocular conditions - in either eye:

  9. History of herpetic infection.

  10. Concurrent disease that could require medical or surgical intervention during the study period.

  11. Active uveitis and/or vitritis (grade: trace or above).

  12. History of idiopathic or autoimmune-associated uveitis.

  13. Active blepharitis, conjunctivitis, keratitis, episcleritis, scleritis, or endophthalmitis.

  14. Any ophthalmologic condition that reduces the clarity of the media and that, in the opinion of the Investigator, interferes with ophthalmologic examination.

  15. 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.

  16. Female subjects must not be pregnant or lactating, nor plan to become pregnant during the study.

  17. Current use of medications known to be toxic to the lens, retina, or optic nerve.

  18. Use of any investigational new drug or other experimental treatment in the last 6 months, and/or receipt of any prior gene therapy (e.g., AAV) or ocular device implantation (other than PCIOL placement following cataract surgery)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Associated Retina Consultants Phoenix Arizona United States 85020
2 California Retina Consultants Bakersfield California United States 93309
3 Retina Vitreous Associates Beverly Hills California United States 90211
4 California Retina Consultants Oxnard California United States 93036
5 Retina Consultants of San Diego Poway California United States 92064
6 California Retina Consultants Santa Barbara California United States 93103
7 California Retina Consultants Santa Maria California United States 93454
8 Colorado Retina Associates Golden Colorado United States 80401
9 Retina Group of New England New London Connecticut United States 06320
10 Retina Care Specialists Palm Beach Gardens Florida United States 33410
11 Retina Vitreous Associates of Florida Saint Petersburg Florida United States 33711
12 Southern Vitreoretinal Associates Tallahassee Florida United States 32308
13 Center For Retina and Macular Disease Winter Haven Florida United States 33880
14 Southeast Retina Center Augusta Georgia United States 30909
15 Georgia Retina PC Marietta Georgia United States 30060
16 Illinois Retina Associates SC Oak Park Illinois United States 60304
17 Raj K Maturi MD PC Indianapolis Indiana United States 46290
18 Midwest Vision Research Foundation Chesterfield Missouri United States 63017
19 Retina Research Institute, LLC Saint Louis Missouri United States 63144
20 Sierra Eye Associates Reno Nevada United States 89502
21 The Retina Center of New Jersey Bloomfield New Jersey United States 07003
22 Western Carolina Retinal Associates Asheville North Carolina United States 28803
23 Charlotte Eye Ear Nose and Throat Associates PA Charlotte North Carolina United States 28210
24 Sterling Vision Eugene Oregon United States 97401
25 Black Hills Regional Eye Institute Rapid City South Dakota United States 57701
26 Retina Research Institute of Texas Abilene Texas United States 79606
27 Texas Retina Associates Dallas Texas United States 75231
28 Retina Consultants of Houston The Woodlands Texas United States 77384
29 Wagner Macula and Retina Center Virginia Beach Virginia United States 23454

Sponsors and Collaborators

  • Gemini Therapeutics, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gemini Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT04643886
Other Study ID Numbers:
  • GEM-CL-10302
  • REGATTA
First Posted:
Nov 25, 2020
Last Update Posted:
Apr 4, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Macular Degeneration
Geographic Atrophy
Retinal Diseases
Retinal Degeneration
Atrophy

Study Results

No Results Posted as of Apr 4, 2022