- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04684394
A Multiple Dose Study of Repeat Intravitreal Injections of GEM103 in Neovascular Age-related Macular Degeneration
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 Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Arizona
-
Phoenix, Arizona, United States, 85021
- Gemini Clinical Trial Site 16
-
-
California
-
Campbell, California, United States, 95008
- Gemini Clinical Trial Site 11
-
Encino, California, United States, 91436
- Gemini Clinical Trial Site 9
-
Huntington Beach, California, United States, 92647
- Gemini Clinical Trial Site 17
-
Pasadena, California, United States, 91107
- Gemini Clinical Trial Site 12
-
-
Florida
-
Miami, Florida, United States, 33143
- Gemini Clinical Trial Site 5
-
Pinellas Park, Florida, United States, 33782
- Gemini Clinical Trial Site 7
-
Sarasota, Florida, United States, 34239
- Gemini Clinical Trial Site 20
-
Stuart, Florida, United States, 34994
- Gemini Clinical Trial Site 8
-
Winter Haven, Florida, United States, 33880
- Gemini Clinical Trial Site 18
-
-
Indiana
-
Indianapolis, Indiana, United States, 46290
- Gemini Clinical Trial Site 19
-
-
Maryland
-
Hagerstown, Maryland, United States, 21740
- Gemini Clinical Trial Site 4
-
-
Massachusetts
-
Worcester, Massachusetts, United States, 01605
- Gemini Clinical Trial Site 23
-
-
Michigan
-
Royal Oak, Michigan, United States, 48073
- Gemini Clinical Trial Site 22
-
-
Nevada
-
Reno, Nevada, United States, 89502
- Gemini Clinical Trial Site 1
-
-
North Carolina
-
Asheville, North Carolina, United States, 28803
- Gemini Clinical Trial Site 2
-
Charlotte, North Carolina, United States, 28210
- Gemini Clinical Trial Site 15
-
-
Ohio
-
Cincinnati, Ohio, United States, 45219
- Gemini Clinical Trial Site 6
-
-
Oregon
-
Eugene, Oregon, United States, 97401
- Gemini Clinical Trial Site 10
-
-
South Carolina
-
Beaufort, South Carolina, United States, 29902
- Gemini Clinical Trial Site 13
-
-
Texas
-
Dallas, Texas, United States, 75231
- Gemini Clinical Trial Site 3
-
San Antonio, Texas, United States, 78240
- Gemini Clinical Trial Site 21
-
San Antonio, Texas, United States, 78247
- Gemini Clinical Trial Site 14
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- At least 50 years old at the time of signed informed consent
Choroidal neovascularization (CNV) related to nAMD with the following features, as determined by the Image Reading Center
- Maximum CNV lesion size of 12 disc areas
- Subretinal hemorrhage less than or equal to (<=) 50% of lesion size
- On aflibercept treatment prior to Day 1
- Best Corrected Visual Acuity (BCVA) in the study eye between 24 to 75 letters using EDTRS
Exclusion Criteria:
Presence of the following ocular conditions in the study eye:
- Any active ocular disease or condition that impact the subject to participate in the study or be a contraindication of IVT injections
- Any intraocular surgery
- Aphakia or complete absence of the posterior capsule
- Prior corneal transplant
- Scar or fibrosis greater than or equal to (>=) 50% of CNV lesion or involving center of fovea
Presence of any of the following ocular conditions in either eye:
- History of herpetic infection, idiopathic polypoidal choroidal vasculopathy (PCV), pathologic myopia, central serous chorioretinopathy (CSCR), adult onset foveal pattern dystrophy
- Concurrent disease that could require medical or surgical intervention during the study period
- Active/suspected ocular/periocular infection or active intraocular inflammation
- History of idiopathic or autoimmune-associated uveitis
- 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
- Has experienced a cardiovascular or cerebrovascular event within 12 months of informed consent
- Females must not be pregnant or lactating
- Current use of medications known to be toxic to the lens, retina or optic nerve
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
GEM103 500 mcg/50 mcL intravitreal injection
Aflibercept 2 mg/50 mcL (SOC) intravitreal injection Sham intravitreal injection |
Sham Comparator: 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.
|
Aflibercept 2 mg/50 mcL (SOC) intravitreal injection Sham intravitreal injection
Sham intravitreal injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Ocular Treatment-emergent Adverse Events (TEAEs)
Time Frame: Baseline up to Week 48
|
An adverse event (AE) was defined as any untoward medical occurrence or worsening of a pre-existing condition in a participant administered a pharmaceutical product during the study, whether related or not to the study medication.
TEAEs were defined as AE that occurred on or after the date and time of study drug administration or those that first occurred pre-dose but worsened by increase in occurrence or severity after study drug administration.
Number of participants with ocular TEAEs in study eye and fellow eye were reported.
|
Baseline up to Week 48
|
Number of Participants With Non-ocular TEAEs
Time Frame: Baseline up to Week 48
|
An adverse event (AE) was defined as any untoward medical occurrence or worsening of a pre-existing condition in a participant administered a pharmaceutical product during the study, whether related or not to the study medication.
TEAEs were defined as AE that occurred on or after the date and time of study drug administration or those that first occurred pre-dose but worsened by increase in occurrence or severity after study drug administration.
Number of participants with non-ocular TEAEs were reported.
|
Baseline up to Week 48
|
Number of Participants With Abnormal Ophthalmic Examination Findings
Time Frame: Baseline up to Week 48
|
Ophthalmoscopy examination was performed in each eye with findings reported for Vitreous, Optic Nerve, Macula, Retina Periphery.
Lens Status and Opacification (Phakic and Pseudophakic) was also performed.
Nuclear Cataract, Cortical Cataract, and Posterior Subcapsular Cataract categories was further summarized by severity grade.
Ocular biomicroscopic examination was performed with findings reported for Lids/Lashes, Conjunctiva, Cornea, Anterior Chamber, and Iris/Pupil.
|
Baseline up to Week 48
|
Percentage of Participants With Greater Than or Equal to (>=)15, >=10, >=5 Letters From the Baseline in Best Corrected Visual Acuity (BCVA)
Time Frame: Baseline up to Week 48
|
Visual function assessments included BCVA assessment in each eye by Early Treatment Diabetic Retinopathy Study (ETDRS) letters.
BCVA was measured on the ETDRS chart at a starting distance of 4 meters.
The letter score ranges from 0 (worse score) to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity.
For each participant, an average value was calculated across the three visits, and this averaged value was used to determine if the endpoint was met.
The results were summarized as the percentage of participants with increase in BCVA with greater than or equal to (>=)15, >=10, >=5 letters from the baseline per treatment arm who met the endpoint.
|
Baseline up to Week 48
|
Percentage of Participants With Greater Than or Equal to (>=)15, >=10, >=5 Letters From the Baseline in Low Luminance Visual Acuity (LLVA)
Time Frame: Baseline up to Week 48
|
Visual function assessments included LLVA assessment in each eye by ETDRS letters.
LLVA was measured on the ETDRS chart at a starting distance of 4 meters.
The letter score ranges from 0 (worse score) to 100 (best score), and a gain in LLVA from baseline indicates an improvement in visual acuity.
For each participant, an average value was calculated across the three visits, and this averaged value was used to determine if the endpoint was met.
The results were summarized as the percentage of participants with increase in LLVA with >=15, >=10, >=5 letters from the baseline per treatment arm who met the endpoint.
|
Baseline up to Week 48
|
Mean Change From Baseline in Minnesota Low-vision Reading (MNRead) Test at Week 48
Time Frame: Baseline, Week 48
|
The MNRead acuity cards are continuous-text reading acuity cards suitable for measuring the reading acuity and reading speed of normal and low-vision participants.
Formula for reading speed words per minute (wpm): reading speed is equal to 60*(10 - errors)/ (time in seconds).
A negative change from baseline indicates a decrease in the reading speed; disease worsening.
|
Baseline, Week 48
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Total Complement Factor H (CFH) Concentration in Aqueous Humor
Time Frame: Baseline, Week 32
|
Observed continuous total CFH concentration level in aqueous humor (ng/mL) was analyzed in study eye only by type of biological matrix by treatment group using descriptive statistics.
Change from baseline in total CFH Concentration in aqueous humor at Week 32 was reported.
|
Baseline, Week 32
|
Mean Change From Baseline in Early Treatment of Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) at Week 48
Time Frame: Baseline, Week 48
|
BCVA was measured on the ETDRS chart at a starting distance of 4 meters in each eye.
The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity.
For each participant, an average BCVA value was calculated across the three visits, and this averaged value was used to determine if the endpoint was met.
All items were transformed on to total score ranges from 0 to 100 (best score).
A negative change indicates no improvement in the condition.
|
Baseline, Week 48
|
Mean Change From Baseline in Macular Atrophy (MA) Assessed by Fundus Autofluorescence (FAF)
Time Frame: Baseline up to Week 48
|
MA lesion area was measured in millimeters squared (mm^2) by FAF in each eye.
The change in MA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center.
A positive change from baseline indicates an increase in size of MA lesion area (worsening; disease progression).
|
Baseline up to Week 48
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GEM-CL-10311
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Macular Degeneration
-
Novartis PharmaceuticalsCompletedNeovascular Age-Related Macular DegenerationChina
-
Hoffmann-La RocheWithdrawnNeovascular Age-Related Macular DegenerationDenmark, Argentina, Hong Kong, Thailand, Portugal, Greece, Spain
-
Novartis PharmaceuticalsCompletedNeovascular Age-Related Macular DegenerationSpain, Italy, Germany, Canada, Ireland
-
Novartis PharmaceuticalsTerminatedNeovascular Age-Related Macular Degeneration
-
Regeneron PharmaceuticalsCompletedNeovascular Age Related Macular DegenerationUnited States
-
Hoffmann-La RocheNot yet recruitingNeovascular Age Related Macular Degeneration | nAMDChina
-
Centre Hospitalier Intercommunal CreteilCompletedMacular Degeneration Exudative Eye Left | Macular Degeneration Exudative Eye RightFrance
-
Shanghai Refreshgene Technology Co., Ltd.RecruitingNeovascular Age-related Macular DegenerationChina
-
PharmAbcineC&R Research, Inc.RecruitingNeovascular Age-related Macular DegenerationKorea, Republic of
-
AsclepiX Therapeutics, Inc.RecruitingNeovascular Age-related Macular DegenerationUnited States
Clinical Trials on GEM103
-
Gemini Therapeutics, Inc.TerminatedMacular Degeneration | Retinal Degeneration | Geographic Atrophy | Dry Age-related Macular Degeneration | Retinal DiseaseUnited States
-
Gemini Therapeutics, Inc.CompletedMacular Degeneration | Retinal Degeneration | Geographic Atrophy | Dry Age-related Macular Degeneration | Retinal DiseaseUnited States