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

• Sponsor: Gemini Therapeutics, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04684394
• Collaborator: (none)
• Enrollment: 50
• Locations: 23
• Arms: 2
• Actual Duration (Months): 12.1
• Patients Per Site: 2.2
• Patients Per Site Per Month: 0.2

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
Neovascular Age-related Macular Degeneration; Retinal Disease; Retinal Degeneration; Macular Degeneration	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: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• 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

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

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

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.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gemini Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT04684394
• 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: 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; Wet Macular Degeneration; Retinal Diseases; Retinal Degeneration

Study Results

No Results Posted as of Mar 23, 2022