- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04358471
Intravitreal AAVCAGsCD59 for Advanced Dry Age-related Macular Degeneration (AMD) With Geographic Atrophy (GA)
May 6, 2021 updated by: Hemera Biosciences
A Phase 2 Multi-Center Trial Evaluating Intravitreal AAVCAGsCD59 Compared to Sham Injection for the Treatment of Advanced Dry Age-Related Macular Degeneration (AMD) With Geographic Atrophy (GA)
Patients with advanced dry AMD with GA meeting inclusion criteria will be randomized in one eye in a 1:1:1 ratio comparing intravitreal high or low dose AAVCAGsCD59 with a sham injection.
All enrolled subjects will be followed for 24 months to evaluate reduction in GA growth and safety of intravitreal AAVCAGsCD59.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Advanced dry AMD with GA in the study eye
- BCVA in the study eye of 80 or less ETDRS letters (Snellen equivalent 20/25 or worse)
- Total cumulative GA lesion size 2.5 mm2 to 12.5 mm2 in the study eye as confirmed by the reading center during the Screening Period.
Exclusion Criteria:
- GA secondary to non-AMD etiologies in the study eye (i.e. myopia, inherited retinal diseases).
- GA associated with the presence of an RPE rip.
- GA contiguous with peripapillary atrophy.
- Active CNV secondary to wet AMD in the study eye and currently receiving anti-VEGF ocular treatment within the previous 18 months.
- Subretinal fibrosis in the macula from CNV both clinically and imaged on SD-OCT in the macula.
- Previous macular laser photocoagulation (i.e. focal or grid laser for macular edema), photodynamic therapy (PDT), ocular/orbital radiation, laser to CNV, or subretinal surgery for CNV in the study eye.
- History of conditions in the study eye which might alter visual acuity or interfere with study testing including proliferative diabetic retinopathy (PDR), clinically significant macular edema (CSME), central retinal vein occlusion (CRVO), hemi retinal vein occlusion (HRVO), macular branch retinal vein occlusion, and optic neuropathy.
- Active uncontrolled glaucoma with at least one of the following: IOP>30 mmHg despite maximum medical treatment with glaucoma medications, cup-to-disc ratio of >0.9, visual field defects secondary to glaucoma that involve the macula, or optic atrophy from glaucoma.
- Active acute or chronic infectious uveitis, retinitis, or conjunctivitis (excluding blepharitis)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Intravitreal AAVCAGsCD59 1.071x10e12 vg Injection
Intravitreal AAVACGsCD59 at a dose of 1.071x10e12 vg administered once on Day 0
|
AAVCAGsCD59 is administered as an intravitreal injection in the enrolled eye
Other Names:
|
Active Comparator: Intravitreal AAVCAGsCD59 3.56x10e11 vg Injection
Intravitreal AAVACGsCD59 at a dose of 3.56x10e11 vg administered once on Day 0
|
AAVCAGsCD59 is administered as an intravitreal injection in the enrolled eye
Other Names:
|
Sham Comparator: Sham Intravitreal Injection
Intravitreal Sham injection administered once on Day 0
|
Sham injection mimics a real injection in the enrolled eye
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluate the change in Geographic Atrophy area (mm2) measured at Day 0 and compared to the measurement at Month 24
Time Frame: 24 Months
|
Geographic atrophy will be measured based on imaging of the retina
|
24 Months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of conversion from dry to wet age-related macular degeneration
Time Frame: 24 Months
|
Measure the number of treated eyes in the sham and AAVCAGsCD59-treated arms that convert from dry to wet age-related macular degeneration
|
24 Months
|
Change in visual acuity of the AAVCAGsCD59 treated eye
Time Frame: 24 Months
|
Visual acuity measured on an Early Treatment Diabetic Retinopathy Study (ETDRS) chart will be compared at Day 0 and Month 24
|
24 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
July 31, 2021
Primary Completion (Anticipated)
July 1, 2023
Study Completion (Anticipated)
September 1, 2023
Study Registration Dates
First Submitted
March 22, 2020
First Submitted That Met QC Criteria
April 20, 2020
First Posted (Actual)
April 24, 2020
Study Record Updates
Last Update Posted (Actual)
May 10, 2021
Last Update Submitted That Met QC Criteria
May 6, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HMR-2001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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 Geographic Atrophy
-
Aviceda Therapeutics, Inc.RecruitingMacular Degeneration | Geographic Atrophy of the MaculaUnited States
-
GlaxoSmithKlineCompletedAtrophy, GeographicUnited States, Canada
-
GlaxoSmithKlineQuintiles, Inc.Completed
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Carl Zeiss Meditec, Inc.DataMed Devices Inc.CompletedAdvanced Dry AMD With Geographic AtrophyUnited States
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Alkeus Pharmaceuticals, Inc.Active, not recruitingGeographic Atrophy | Age Related Macular Degeneration | AMD | Atrophy, GeographicUnited States
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Apellis Pharmaceuticals, Inc.Active, not recruitingGeographic Atrophy Secondary to Age-related Macular DegenerationUnited States, Netherlands, France, Israel, Germany, United Kingdom, Canada, Czechia, Australia, Spain, Italy, Argentina, Brazil, New Zealand, Poland
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IVERIC bio, Inc.Active, not recruitingMacular Degeneration | Geographic AtrophyUnited States, Latvia, France, Germany, Spain, Hungary, Canada, Israel, Argentina, Czechia, Colombia, Croatia, Italy
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Boehringer IngelheimCompletedGeographic AtrophyUnited States
-
Genentech, Inc.Completed
-
Apellis Pharmaceuticals, Inc.CompletedGeographic AtrophyUnited States, Australia, New Zealand
Clinical Trials on Intravitreal AAVCAGsCD59
-
Janssen Research & Development, LLCCompletedDry Age-related Macular DegenerationUnited States
-
Janssen Research & Development, LLCCompleted
-
Perfuse Therapeutics, Inc.Recruiting
-
Perfuse Therapeutics, Inc.Recruiting
-
Jeffrey S HeierKato Pharmaceuticals, Inc.CompletedVitreomacular Traction | Vitreomacular Adhesion | Vitreomacular AttachmentUnited States
-
Afyonkarahisar Health Sciences UniversityCompleted
-
Indonesia UniversityBayerCompletedDiabetic Retinopathy | Diabetic Macular Edema | Clinically Significant Macular EdemaIndonesia
-
Peregrine Eye and Laser InstituteCompletedDiabetic Macular Edema | Choroidal Neovascularization | Neovascular Age-related Macular Degeneration | Uveitic Macular Edema | Retinal Vein Occlusion With Macular EdemaPhilippines
-
Eye & ENT Hospital of Fudan UniversityUnknownDiabetic Retinopathy | Diabetic Macular Edema | Cataract Diabetic
-
L.V. Prasad Eye InstitutePfizerWithdrawnMyopic Choroidal Neovascular MembraneIndia