Dry Age-related Macular DegenerationPhase 2NCT04643886
A Multiple Dose Study of Repeat Intravitreal Injections of GEM103 in Dry Age-related Macular Degeneration
A Phase 2 study testing GEM103 in people with Dry Age-related Macular Degeneration and Geographic Atrophy, run by Gemini Therapeutics, Inc. at 29 sites in United States.
Trial summary
This study is designed to investigate the safety, PK/PD, biomarker and early clinical effects of repeat GEM103 IVT injections. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Dry Age-related Macular Degeneration, Geographic Atrophy, Macular Degeneration
- What is being tested?
- GEM103
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 29 sitesUnited States
- Study dates
- 30 Jul 2020to 21 Mar 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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.
- Must have one of the following genetic profiles:
- Genetic Profile A.
- Genetic Profile B.
- BCVA in the study eye of 24 to 83 letters using ETDRS Chart Visual Acuity (VA) Scale (approximately equivalent to Snellen VA of 20/25 to 20/320).
- Confirmed diagnosis of GA in the study eye where total size of all GA lesions in the study eye must be within 0.5 to 15.01- and 7- disc areas.
- Sufficiently clear ocular media and able to cooperate with ophthalmic visual function testing and anatomic assessment in the study eye.
- Understands the full nature and purpose of the study and provides informed consent prior to initiation of any study procedure; all subjects with a reproductive potential must agree to use effective contraceptive methods through the end of study (EOS) Visit.
Who cannot join
- Presence of the following ocular conditions - in the study eye:
- Any history of exudative Age-related Macular Degeneration or choroidal neovascularization.
- Any active ocular disease or condition that could confound the assessment of the macula or be a contraindication to IVT injection.
- Any intraocular surgery, with the exception of stable intraocular lens replacement surgery more than 3 months prior to consent.
- Aphakia or complete absence of the posterior capsule.
- History of laser therapy to the macula or fundus or extensive laser to the retina.
Show all 18Show fewer
- Prior corneal transplant.
- Presence of any of the following ocular conditions - in either eye:
- History of herpetic infection.
- Concurrent disease that could require medical or surgical intervention during the study period.
- Active uveitis and/or vitritis (grade: trace or above).
- History of idiopathic or autoimmune-associated uveitis.
- Active blepharitis, conjunctivitis, keratitis, episcleritis, scleritis, or endophthalmitis.
- Any ophthalmologic condition that reduces the clarity of the media and that, in the opinion of the Investigator, interferes with ophthalmologic examination.
- In the opinion of the Investigator, the subject has any prior or ongoing medical condition (e.g., ocular other than dry AMD, systemic, psychiatric) or clinically significant screening laboratory value that may present a safety risk, interfere with study compliance or study follow-up, or confound data interpretation throughout the follow-up period.
- Female subjects must not be pregnant or lactating, nor plan to become pregnant during the study.
- 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, and/or receipt of any prior gene therapy (e.g., AAV) or ocular device implantation (other than PCIOL placement following cataract surgery)
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
United States29 sites
Gemini Clinical Trial Site
Abilene, Texas, 79606
Gemini Clinical Trial Site
Asheville, North Carolina, 28803
Gemini Clinical Trial Site
Augusta, Georgia, 30909
Gemini Clinical Trial Site
Bakersfield, California, 93309
Gemini Clinical Trial Site
Beverly Hills, California, 90211
Gemini Clinical Trial Site
Bloomfield, New Jersey, 07003
Gemini Clinical Trial Site
Charlotte, North Carolina, 28210
Gemini Clinical Trial Site
Chesterfield, Missouri, 63017
Gemini Clinical Trial Site
Dallas, Texas, 75231
Gemini Clinical Trial Site
Eugene, Oregon, 97401
Gemini Clinical Trial Site
Golden, Colorado, 80401
Gemini Clinical Trial Site
Indianapolis, Indiana, 46290
Gemini Clinical Trial Site
Marietta, Georgia, 30060
Gemini Clinical Trial Site
New London, Connecticut, 06320
Gemini Clinical Trial Site
Oak Park, Illinois, 60304
Gemini Clinical Trial Site
Oxnard, California, 93036
Gemini Clinical Trial Site
Palm Beach Gardens, Florida, 33410
Gemini Clinical Trial Site
Phoenix, Arizona, 85020
Gemini Clinical Trial Site
Poway, California, 92064
Gemini Clinical Trial Site
Rapid City, South Dakota, 57701
Gemini Clinical Trial Site
Reno, Nevada, 89502
Gemini Clinical Trial Site
Santa Barbara, California, 93103
Gemini Clinical Trial Site
Santa Maria, California, 93454
Gemini Clinical Trial Site
St Louis, Missouri, 63144
Gemini Clinical Trial Site
St. Petersburg, Florida, 33711
Gemini Clinical Trial Site
Tallahassee, Florida, 32308
Gemini Clinical Trial Site
The Woodlands, Texas, 77384
Gemini Clinical Trial Site
Virginia Beach, Virginia, 23454
Gemini Clinical Trial Site
Winter Haven, Florida, 33880
About this study
Official title: A Multicenter, Open-label, Multiple Dose Study in Patients With Geographic Atrophy Secondary to Dry Age-related Macular Degeneration to Evaluate the Safety, Tolerability, Pharmacodynamics, and Immunogenicity of Repeat Intravitreal Injections of GEM103
This study is designed to investigate the safety, PK/PD, biomarker and early clinical effects of repeat GEM103 IVT injections.
Read the detailed description
This is a Phase 2a, multi-center, open-label, multiple dose study in subjects with geographic atrophy (GA) secondary to dry Age-related Macular Degeneration (dry AMD) to investigate the safety, PK/PD, biomarker and early clinical effect of GEM103 repeat IVT injections.
Subjects will undergo clinical and ophthalmic assessments for determination of inclusion in the study. Subjects who participated in the Phase 1 Study (GEM-CL-10301) as well as treatment naïve subjects that did not participate in the GEM-CL-10301 Study and who meet all eligibility criteria will be enrolled.
- Conditions
- Dry Age-related Macular Degeneration, Geographic Atrophy, Macular Degeneration, Retinal Disease, Retinal Degeneration
- Being tested
- GEM103
- Medical subject headings
- Geographic Atrophy, Macular Degeneration, Retinal Diseases, Retinal Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GEM103Drug
Biological
| Study group | Role | What they receive |
|---|---|---|
| Cohort with Genetic Profile A | Experimental | Subjects will have Genetic Profile A.
Intervention: Biological: GEM103. Receives: Drug: GEM103 |
| Cohort with Genetic Profile B | Experimental | Subjects will have Genetic Profile B.
Intervention: Biological: GEM103 Receives: Drug: GEM103 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of intravitreal (IVT) injections of GEM103, as measured by number of subjects with ocular adverse events.
Measured: 18 months
Secondary outcomes (2)
To describe the clinical effect of GEM103 IVT injection, as the change from baseline in best corrected visual acuity (BCVA) scores as assessed by ETDRS scale.
Measured: 6 months
To evaluate the total CFH levels in aqueous humor after GEM103 IVT injection, whenever possible.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start30 Jul 2020
- Primary completion18 Feb 2022
- Study completion21 Mar 2022
Why it stopped: no further benefit
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dry 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
- None (open label)
- Enrolment
- 62 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
- NCT04643886
- Sponsor's protocol ID
- GEM-CL-10302
- Other IDs
- REGATTA
- Status last verified
- Sep 2022
- First submitted
- 16 Nov 2020
- Last updated
- 23 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tzoumas N, Riding G, Williams MA, Steel DH. Complement inhibitors for age-related macular degeneration. Cochrane Database Syst Rev. 2023 Jun 14;6(6):CD009300. doi: 10.1002/14651858.CD009300.pub3.
PubMed 37314061
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Multiple Dose Study in Patients With Geographic Atrophy Secondary to Dry Age-related Macular Degeneration to Evaluate the Safety, Tolerability, Pharmacodynamics, and Immunogenicity of Repeat Intravitreal Injections of GEM103
- ClinicalTrials.gov ID
- NCT04643886
- Acronym / sponsor ID
- GEM-CL-10302
- Conditions
- Dry Age-related Macular Degeneration, Geographic Atrophy, Macular Degeneration, Retinal Disease, Retinal Degeneration
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: no further benefit
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Gemini Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Jul 2020 (actual)
- Primary completion
- 18 Feb 2022 (actual)
- Study completion
- 21 Mar 2022 (actual)
- First posted
- 25 Nov 2020 (actual)
- Results
- Not posted in the source record
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, PK/PD, biomarker and early clinical effects of repeat GEM103 IVT injections.
Detailed description
This is a Phase 2a, multi-center, open-label, multiple dose study in subjects with geographic atrophy (GA) secondary to dry Age-related Macular Degeneration (dry AMD) to investigate the safety, PK/PD, biomarker and early clinical effect of GEM103 repeat IVT injections.
Subjects will undergo clinical and ophthalmic assessments for determination of inclusion in the study. Subjects who participated in the Phase 1 Study (GEM-CL-10301) as well as treatment naïve subjects that did not participate in the GEM-CL-10301 Study and who meet all eligibility criteria will be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort with Genetic Profile A | Experimental | Drug: GEM103Subjects will have Genetic Profile A. Intervention: Biological: GEM103. |
| Cohort with Genetic Profile B | Experimental | Drug: GEM103Subjects will have Genetic Profile B. Intervention: Biological: GEM103 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- At least 50 years old at the time of signed informed consent.
- Must have one of the following genetic profiles:
- BCVA in the study eye of 24 to 83 letters using ETDRS Chart Visual Acuity (VA) Scale (approximately equivalent to Snellen VA of 20/25 to 20/320).
- Confirmed diagnosis of GA in the study eye where total size of all GA lesions in the study eye must be within 0.5 to 15.01- and 7- disc areas.
- Sufficiently clear ocular media and able to cooperate with ophthalmic visual function testing and anatomic assessment in the study eye.
Key exclusion criteria (18 listed)
- Presence of the following ocular conditions - in the study eye:
- Presence of any of the following ocular conditions - in either eye:
- In the opinion of the Investigator, the subject has any prior or ongoing medical condition (e.g., ocular other than dry AMD, systemic, psychiatric) or clinically significant screening laboratory value that may present a safety risk, interfere with study compliance or study follow-up, or confound data interpretation throughout the follow-up period.
- Female subjects must not be pregnant or lactating, nor plan to become pregnant during the study.
- Current use of medications known to be toxic to the lens, retina, or optic nerve.
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 |
|---|---|---|
| GEM103Biological | Drug | Cohort with Genetic Profile A, Cohort with Genetic Profile B |
Primary outcome
Safety of intravitreal (IVT) injections of GEM103, as measured by number of subjects with ocular adverse events.
Time frame: 18 months
2 secondary outcomes
To describe the clinical effect of GEM103 IVT injection, as the change from baseline in best corrected visual acuity (BCVA) scores as assessed by ETDRS scale.
Time frame: 6 months
To evaluate the total CFH levels in aqueous humor after GEM103 IVT injection, whenever possible.
Time frame: 6 months
Results and safety
The study was stopped early (reason given: no further benefit). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2022.
- Derived from this study: PubMed 37314061Tzoumas N, Riding G, Williams MA, Steel DH. Complement inhibitors for age-related macular degeneration. Cochrane Database Syst Rev. 2023 Jun 14;6(6):CD009300. doi: 10.1002/14651858.CD009300.pub3.
- Individual participant dataSharing planned: No
Related trials for Dry Age-related Macular Degeneration
RecruitingPhase 1/2
Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration
Dry Age-Related Macular Degeneration, Geographic Atrophy
Not yet recruiting
Safety and Clinical Performance of the LENTIS® MAX LS-313 MF80 Compared With the Monofocal L-313 in Cataract Patients With Late Age-Related Macular Degeneration: A Multicenter Comparative Clinical Investigation.
Cataract, AMD - Age-Related Macular Degeneration
Not yet recruiting
MacuMira Microcurrent Stimulation for Dark Adaptation in Dry Age-Related Macular Degeneration
Age-Related Macular Degeneration (AMD)
Active, not recruitingPhase 1/2
Study to Assess the Safety and Efficacy of OCU410 for Geographic Atrophy
Geographic Atrophy
Active, not recruitingPhase 1/2
Safety and Efficacy Study of OpRegen for Treatment of Advanced Dry-Form Age-Related Macular Degeneration
Age-Related Macular Degeneration
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.
29 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 in people with Dry Age-related Macular Degeneration and Geographic Atrophy, run by Gemini Therapeutics, Inc. at 29 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 8 inclusion and 18 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 23 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 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. 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?
The study was stopped early (reason given: no further benefit). Results are not available in the source record.
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?
Safety of intravitreal (IVT) injections of GEM103, as measured by number of subjects with ocular adverse events. (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04643886, which also lists 1 linked publication.
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 23 Sep 2022.