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

NCT ID: NCT04684394

Last Updated: 2022-10-31

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-29
• Study Completion Date: 2022-02-18

Brief Summary

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

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.

Conditions

Neovascular Age-related Macular Degeneration; Retinal Disease; Retinal Degeneration; Macular Degeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

SoC + GEM103

Participants were administered SoC therapy defined as aflibercept (2 milligram \[mg\]/50 microliter \[mcL\]) first, followed by GEM103 (500 microgram \[mcg\]/50mcL) 15 minutes later. Administration occurred every other month (EOM) for a total of 6 doses during the 12-month study period.

Group Type: EXPERIMENTAL

GEM103

Intervention Type: BIOLOGICAL

GEM103 500 mcg/50 mcL intravitreal injection

Aflibercept

Intervention Type: DRUG

Aflibercept 2 mg/50 mcL (SOC) intravitreal injection

Sham intravitreal injection

SoC + Sham

Participants were administered SoC therapy defined as aflibercept (2mg/50mcL) first, followed by the Sham injection 15 minutes later. Administration occurred EOM for a total of 6 doses during the 12-month study period.

Group Type: SHAM_COMPARATOR

Aflibercept

Intervention Type: DRUG

Aflibercept 2 mg/50 mcL (SOC) intravitreal injection

Sham intravitreal injection

Sham

Intervention Type: DRUG

Sham intravitreal injection

Interventions

GEM103

GEM103 500 mcg/50 mcL intravitreal injection

Intervention Type: BIOLOGICAL

Aflibercept

Aflibercept 2 mg/50 mcL (SOC) intravitreal injection

Sham intravitreal injection

Intervention Type: DRUG

Sham

Sham intravitreal injection

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

2. Choroidal neovascularization (CNV) related to nAMD with the following features, as determined by the Image Reading Center

1. Maximum CNV lesion size of 12 disc areas

2. Subretinal hemorrhage less than or equal to (<=) 50% of lesion size

3. On aflibercept treatment prior to Day 1

4. Best Corrected Visual Acuity (BCVA) in the study eye between 24 to 75 letters using EDTRS

Exclusion Criteria

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

1. Any active ocular disease or condition that impact the subject to participate in the study or be a contraindication of IVT injections

2. Any intraocular surgery

3. Aphakia or complete absence of the posterior capsule

4. Prior corneal transplant

5. Scar or fibrosis greater than or equal to (>=) 50% of CNV lesion or involving center of fovea

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

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

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

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

4. History of idiopathic or autoimmune-associated uveitis

3. Any prior or ongoing medical condition 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. Has experienced a cardiovascular or cerebrovascular event within 12 months of informed consent

5. Females must not be pregnant or lactating

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

7. Use of any investigational new drug or other experimental treatment in the last 6 months prior to Day 1, and/or receipt of any prior gene therapy or ocular device implantation

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gemini Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Gemini Clinical Trial Site 16

Phoenix, Arizona, United States

Gemini Clinical Trial Site 11

Campbell, California, United States

Gemini Clinical Trial Site 9

Encino, California, United States

Gemini Clinical Trial Site 17

Huntington Beach, California, United States

Gemini Clinical Trial Site 12

Pasadena, California, United States

Gemini Clinical Trial Site 5

Miami, Florida, United States

Gemini Clinical Trial Site 7

Pinellas Park, Florida, United States

Gemini Clinical Trial Site 20

Sarasota, Florida, United States

Gemini Clinical Trial Site 8

Stuart, Florida, United States

Gemini Clinical Trial Site 18

Winter Haven, Florida, United States

Gemini Clinical Trial Site 19

Indianapolis, Indiana, United States

Gemini Clinical Trial Site 4

Hagerstown, Maryland, United States

Gemini Clinical Trial Site 23

Worcester, Massachusetts, United States

Gemini Clinical Trial Site 22

Royal Oak, Michigan, United States

Gemini Clinical Trial Site 1

Reno, Nevada, United States

Gemini Clinical Trial Site 2

Asheville, North Carolina, United States

Gemini Clinical Trial Site 15

Charlotte, North Carolina, United States

Gemini Clinical Trial Site 6

Cincinnati, Ohio, United States

Gemini Clinical Trial Site 10

Eugene, Oregon, United States

Gemini Clinical Trial Site 13

Beaufort, South Carolina, United States

Gemini Clinical Trial Site 3

Dallas, Texas, United States

Gemini Clinical Trial Site 21

San Antonio, Texas, United States

Gemini Clinical Trial Site 14

San Antonio, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

GEM-CL-10311

Identifier Type: -

Identifier Source: org_study_id