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

Gemini Therapeutics, Inc. (Industry)
Overall Status
CT.gov ID

Study Details

Study Description

Brief Summary

This study is designed to investigate the safety and tolerability of GEM103 IVT injection + standard of care vs. sham + standard of care.

Condition or Disease Intervention/Treatment Phase
  • Biological: GEM103
  • Drug: sham + SoC
Phase 2

Detailed Description

This is a Phase 2a, multi-center, multiple dose study in subjects with Neovascular Age-related Macular Degeneration (nAMD) to investigate the safety and tolerability of GEM103 IVT injection + standard of care vs. sham + standard of care.

Subjects will undergo clinical and ophthalmic assessments for determination of inclusion in the study and who meet all eligibility criteria will be enrolled.

Study Design

Study Type:
Actual Enrollment :
50 participants
Intervention Model:
Parallel Assignment
Single (Participant)
Primary Purpose:
Official Title:
A Multicenter, Multiple-Dose Study in Neovascular Age-related Macular Degeneration (nAMD) to Evaluate the Safety, Tolerability, Pharmacodynamics, Immunogenicity, and Clinical Effect of Repeat Intravitreal (IVT) Injections of GEM103 as an Adjunct to Standard of Care Aflibercept Therapy
Actual Study Start Date :
Dec 29, 2020
Actual Primary Completion Date :
Sep 30, 2021
Actual Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: GEM103 + SoC

Biological: GEM103
Drug: GEM103 Biological

Sham Comparator: Sham+SoC

Drug: sham + SoC
SoC defined as 2 mg aflibercept EOM

Outcome Measures

Primary Outcome Measures

  1. Safety of GEM103 as measured by treatment-related intraocular AEs [6 months]

Secondary Outcome Measures

  1. 2. Pharmacokinetics, as measured by total CFH in aqueous humor after GEM103 IVT injection, whenever possible. [12 months]

  2. Describe the effect on vision, as measured by mean change in BCVA from baseline in ETDRS letters. [12 months]

  3. 4. Describe the effect on macular atrophy size as measured by mean change from baseline, evaluated by FAF. [12 months]

Eligibility Criteria


Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Inclusion Criteria:
  1. At least 50 years old at the time of signed informed consent
  1. CNV related to nAMD, with maximum CNV lesion size is 12 disc area and subretinal hemorrhage ≤50% of lesion size
  1. On aflibercept treatment at enrollment

  2. BCVA in the study eye of 24 to 75 letters using the ETDRS Chart VA Scale (approximately equivalent to Snellen VA of between 20/32 and 20/320)

Exclusion Criteria:
  1. Presence of the following ocular conditions in the study eye:

  2. Any active ocular disease or condition that could confound the assessment of the macula or be a contraindication to IVT injection, severe glaucoma, ocular infection of any nature, diabetic retinopathy graded as moderate nonproliferative diabetic retinopathy or worse (with or without diabetic macular edema)

  3. Any intraocular surgery,

  4. Aphakia or complete absence of the posterior capsule

  5. Prior corneal transplant

  6. Scar or fibrosis ≥50% of lesion or involving center of fovea

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

  8. History of herpetic infection, idiopathic polypoidal choroidal vasculopathy (PCV), pathologic myopia, central serous chorioretinopathy (CSCR), adult onset foveal pattern dystrophy

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

  10. Active/suspected ocular/periocular infection or active intraocular inflammation

  11. History of idiopathic or autoimmune-associated uveitis

  12. Subject has experienced a cardiovascular or cerebrovascular event within 12 months of informed consent

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

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

  15. 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. Adeno- associated virus) or ocular device implantation (other than posterior chamber intraocular lens placement after cataract surgery)

Contacts and Locations


Site City State Country Postal Code
1 Arizona Retina and Vitreous Consultant Phoenix Arizona United States 85021
2 Retinal Diagnostic Center of Northern California Campbell California United States 95008
3 The Retina Partners Encino California United States 91436
4 Salehi Retina Institute Huntington Beach California United States 92647
5 California Eye Specialists Medical Group Pasadena California United States 91107
6 MedEye Associates Miami Florida United States 33143
7 Eye Associates of Pinellas Pinellas Park Florida United States 33782
8 Sarasota Retina Institute Sarasota Florida United States 34239
9 East Florida Eye Institute Stuart Florida United States 34994
10 Center for Retina and Macular Disease Winter Haven Florida United States 33880
11 Midwest Eye Institute Indianapolis Indiana United States 46290
12 Mid Atlantic Retina Specialists Hagerstown Maryland United States 21740
13 Vitreo-Retinal Asociates, Pc Worcester Massachusetts United States 01605
14 Beaumont Neuroscience Center Building Royal Oak Michigan United States 48073
15 Sierra Eye Associates Reno Nevada United States 89502
16 Western Carolina Retinal Associates Asheville North Carolina United States 28803
17 Charlotte Eye Ear Nose and Throat Associates PA Charlotte North Carolina United States 28210
18 Sterling Research Group Cincinnati Ohio United States 45219
19 Oregon Retina LLP Eugene Oregon United States 97401
20 Retina Research of Beaufort Beaufort South Carolina United States 29902
21 Texas Retina Associates Dallas Texas United States 75231
22 Retinal Consultants of San Antonio San Antonio Texas United States 78240
23 Medical Center Ophthalmology Associates San Antonio Texas United States 78247

Sponsors and Collaborators

  • Gemini Therapeutics, Inc.


None specified.

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Gemini Therapeutics, Inc.
ClinicalTrials.gov Identifier:
Other Study ID Numbers:
  • GEM-CL-10311
First Posted:
Dec 24, 2020
Last Update Posted:
Mar 23, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 23, 2022