Neovascular Age-related Macular DegenerationPhase 2NCT04684394
A Multiple Dose Study of Repeat Intravitreal Injections of GEM103 in Neovascular Age-related Macular Degeneration
A Phase 2 study testing GEM103 and Aflibercept in people with Neovascular Age-related Macular Degeneration and Retinal Disease, run by Gemini Therapeutics, Inc. at 23 sites in United States.
Trial summary
This study is designed to investigate the safety and tolerability of GEM103 IVT injection + standard of care vs. sham + standard of care. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Neovascular Age-related Macular Degeneration, Retinal Disease, Retinal Degeneration
- What is being tested?
- GEM103 and Aflibercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 23 sitesUnited States
- Study dates
- 29 Dec 2020to 18 Feb 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Gemini Clinical Trial Site 2
Asheville, North Carolina, 28803
Gemini Clinical Trial Site 13
Beaufort, South Carolina, 29902
Gemini Clinical Trial Site 11
Campbell, California, 95008
Gemini Clinical Trial Site 15
Charlotte, North Carolina, 28210
Gemini Clinical Trial Site 6
Cincinnati, Ohio, 45219
Gemini Clinical Trial Site 3
Dallas, Texas, 75231
Gemini Clinical Trial Site 9
Encino, California, 91436
Gemini Clinical Trial Site 10
Eugene, Oregon, 97401
Gemini Clinical Trial Site 4
Hagerstown, Maryland, 21740
Gemini Clinical Trial Site 17
Huntington Beach, California, 92647
Gemini Clinical Trial Site 19
Indianapolis, Indiana, 46290
Gemini Clinical Trial Site 5
Miami, Florida, 33143
Gemini Clinical Trial Site 12
Pasadena, California, 91107
Gemini Clinical Trial Site 16
Phoenix, Arizona, 85021
Gemini Clinical Trial Site 7
Pinellas Park, Florida, 33782
Gemini Clinical Trial Site 1
Reno, Nevada, 89502
Gemini Clinical Trial Site 22
Royal Oak, Michigan, 48073
Gemini Clinical Trial Site 21
San Antonio, Texas, 78240
Gemini Clinical Trial Site 14
San Antonio, Texas, 78247
Gemini Clinical Trial Site 20
Sarasota, Florida, 34239
Gemini Clinical Trial Site 8
Stuart, Florida, 34994
Gemini Clinical Trial Site 18
Winter Haven, Florida, 33880
Gemini Clinical Trial Site 23
Worcester, Massachusetts, 01605
About this study
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
This study is designed to investigate the safety and tolerability of GEM103 IVT injection + standard of care vs. sham + standard of care.
Read the 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
- Being tested
- GEM103, Aflibercept, Sham
- Medical subject headings
- Retinal Diseases, Retinal Degeneration, Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GEM103Biological
GEM103 500 mcg/50 mcL intravitreal injection
AfliberceptDrug
Aflibercept 2 mg/50 mcL (SOC) intravitreal injection
Sham intravitreal injection
ShamDrug
Sham intravitreal injection
| Study group | Role | What they receive |
|---|---|---|
| SoC + GEM103 | Experimental | 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. Receives: Biological: GEM103; Drug: Aflibercept |
| SoC + Sham | Sham comparator | 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. Receives: Drug: Aflibercept; Drug: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Ocular Treatment-emergent Adverse Events (TEAEs)
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.
Measured: Baseline up to Week 48
Number of Participants With Non-ocular TEAEs
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.
Measured: Baseline up to Week 48
Number of Participants With Abnormal Ophthalmic Examination Findings
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: Baseline up to Week 48
Mean Change From Baseline in Minnesota Low-vision Reading (MNRead) Test at 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.
Measured: Baseline, Week 48
Secondary outcomes (3)
Change From Baseline in Total Complement Factor H (CFH) Concentration in Aqueous Humor
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.
Measured: Baseline, Week 32
Mean Change From Baseline in Early Treatment of Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) at 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.
Measured: Baseline, Week 48
Mean Change From Baseline in Macular Atrophy (MA) Assessed by Fundus Autofluorescence (FAF)
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).
Measured: Baseline up to Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start29 Dec 2020
- Primary completion10 Jan 2022
- Study completion18 Feb 2022
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Neovascular Age-related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gemini Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04684394
- Sponsor's protocol ID
- GEM-CL-10311
- Status last verified
- Mar 2022
- First submitted
- 21 Dec 2020
- Last updated
- 31 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04684394
- Acronym / sponsor ID
- GEM-CL-10311
- Conditions
- Neovascular Age-related Macular Degeneration, Retinal Disease, Retinal Degeneration, Macular Degeneration
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Gemini Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Dec 2020 (actual)
- Primary completion
- 10 Jan 2022 (actual)
- Study completion
- 18 Feb 2022 (actual)
- First posted
- 24 Dec 2020 (actual)
- Results
- Posted 31 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SoC + GEM103 | Experimental | Biological: GEM103, Drug: AfliberceptParticipants 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. |
| SoC + Sham | Sham comparator | Drug: Aflibercept, Drug: ShamParticipants 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
- On aflibercept treatment prior to Day 1
- Best Corrected Visual Acuity (BCVA) in the study eye between 24 to 75 letters using EDTRS
Key exclusion criteria (16 listed)
- Presence of the following ocular conditions in the study eye:
- Presence of any of the following ocular conditions in either eye:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GEM103GEM103 500 mcg/50 mcL intravitreal injection | Biological | SoC + GEM103 |
| AfliberceptAflibercept 2 mg/50 mcL (SOC) intravitreal injection Sham intravitreal injection | Drug | SoC + GEM103, SoC + Sham |
| ShamSham intravitreal injection | Drug | SoC + Sham |
Primary outcome
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.
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.
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.
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.
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.
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.
3 secondary outcomes
Change From Baseline in Total Complement Factor H (CFH) Concentration in Aqueous Humor
Time frame: 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
Mean Change From Baseline in Macular Atrophy (MA) Assessed by Fundus Autofluorescence (FAF)
Time frame: Baseline up to Week 48
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GEM103 and Aflibercept in people with Neovascular Age-related Macular Degeneration and Retinal Disease, run by Gemini Therapeutics, Inc. at 23 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Ocular Treatment-emergent Adverse Events (TEAEs) (time frame: Baseline up to Week 48). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2022.