Clinical trial NCT04684394: A Multiple Dose Study of Repeat Intravitreal Injections of GEM103 in Neovascular Age-related Macular Degeneration
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Neovascular Age-related Macular Degeneration
Retinal Disease
Retinal Degeneration
Macular Degeneration
Lead sponsor: Gemini Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2020-12-24
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Participants With Ocular Treatment-emergent Adverse Events (TEAEs)
timeFrame: Baseline up to Week 48
measure: Number of Participants With Non-ocular TEAEs
timeFrame: Baseline up to Week 48
measure: Number of Participants With Abnormal Ophthalmic Examination Findings
timeFrame: Baseline up to Week 48
measure: Percentage of Participants With Greater Than or Equal to (>=)15, >=10, >=5 Letters From the Baseline in Best Corrected Visual Acuity (BCVA)
timeFrame: Baseline up to Week 48
measure: Percentage of Participants With Greater Than or Equal to (>=)15, >=10, >=5 Letters From the Baseline in Low Luminance Visual Acuity (LLVA)
timeFrame: Baseline up to Week 48
measure: Mean Change From Baseline in Minnesota Low-vision Reading (MNRead) Test at Week 48
timeFrame: Baseline, Week 48
Secondary outcomes:
measure: Change From Baseline in Total Complement Factor H (CFH) Concentration in Aqueous Humor
timeFrame: Baseline, Week 32
measure: Mean Change From Baseline in Early Treatment of Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) at Week 48
timeFrame: Baseline, Week 48
measure: Mean Change From Baseline in Macular Atrophy (MA) Assessed by Fundus Autofluorescence (FAF)
timeFrame: Baseline up to Week 48
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Gemini Clinical Trial Site 16
state: Arizona
city: Campbell
country: United States
facility: Gemini Clinical Trial Site 11
state: California
city: Encino
country: United States
facility: Gemini Clinical Trial Site 9
state: California
city: Huntington Beach
country: United States
facility: Gemini Clinical Trial Site 17
state: California
city: Pasadena
country: United States
facility: Gemini Clinical Trial Site 12
state: California
city: Miami
country: United States
facility: Gemini Clinical Trial Site 5
state: Florida
city: Pinellas Park
country: United States
facility: Gemini Clinical Trial Site 7
state: Florida
city: Sarasota
country: United States
facility: Gemini Clinical Trial Site 20
state: Florida
city: Stuart
country: United States
facility: Gemini Clinical Trial Site 8
state: Florida
city: Winter Haven
country: United States
facility: Gemini Clinical Trial Site 18
state: Florida
city: Indianapolis
country: United States
facility: Gemini Clinical Trial Site 19
state: Indiana
city: Hagerstown
country: United States
facility: Gemini Clinical Trial Site 4
state: Maryland
city: Worcester
country: United States
facility: Gemini Clinical Trial Site 23
state: Massachusetts
city: Royal Oak
country: United States
facility: Gemini Clinical Trial Site 22
state: Michigan
city: Reno
country: United States
facility: Gemini Clinical Trial Site 1
state: Nevada
city: Asheville
country: United States
facility: Gemini Clinical Trial Site 2
state: North Carolina
city: Charlotte
country: United States
facility: Gemini Clinical Trial Site 15
state: North Carolina
city: Cincinnati
country: United States
facility: Gemini Clinical Trial Site 6
state: Ohio
city: Eugene
country: United States
facility: Gemini Clinical Trial Site 10
state: Oregon
city: Beaufort
country: United States
facility: Gemini Clinical Trial Site 13
state: South Carolina
city: Dallas
country: United States
facility: Gemini Clinical Trial Site 3
state: Texas
city: San Antonio
country: United States
facility: Gemini Clinical Trial Site 21
state: Texas
city: San Antonio
country: United States
facility: Gemini Clinical Trial Site 14
state: Texas
Study officials:
References: