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Intravitreal AAVCAGsCD59 for Advanced Dry Age-related Macular Degeneration (AMD) With Geographic Atrophy (GA)

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ClinicalTrials.gov Identifier: NCT04358471
Recruitment Status : Withdrawn (The AAVCAGsCD59 asset has been transferred to Janssen Research and Development LLC)
First Posted : April 24, 2020
Last Update Posted : May 10, 2021
Sponsor:
Information provided by (Responsible Party):
Hemera Biosciences

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Dry Age-related Macular Degeneration Geographic Atrophy Gene Therapy Intravitreal Injection Biological: Intravitreal AAVCAGsCD59 Other: Intravitreal Sham Injection Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects will be assigned to low dose AAVCAGsCD59, high dose AAVCAGsCD59, or sham arm.
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)
Estimated Study Start Date : July 31, 2021
Estimated Primary Completion Date : July 1, 2023
Estimated Study Completion Date : September 1, 2023

Resource links provided by the National Library of Medicine


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
Biological: Intravitreal AAVCAGsCD59
AAVCAGsCD59 is administered as an intravitreal injection in the enrolled eye
Other Name: HMR59

Active Comparator: Intravitreal AAVCAGsCD59 3.56x10e11 vg Injection
Intravitreal AAVACGsCD59 at a dose of 3.56x10e11 vg administered once on Day 0
Biological: Intravitreal AAVCAGsCD59
AAVCAGsCD59 is administered as an intravitreal injection in the enrolled eye
Other Name: HMR59

Sham Comparator: Sham Intravitreal Injection
Intravitreal Sham injection administered once on Day 0
Other: Intravitreal Sham Injection
Sham injection mimics a real injection in the enrolled eye
Other Name: Sham




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Advanced dry AMD with GA in the study eye
  2. BCVA in the study eye of 80 or less ETDRS letters (Snellen equivalent 20/25 or worse)
  3. 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:

  1. GA secondary to non-AMD etiologies in the study eye (i.e. myopia, inherited retinal diseases).
  2. GA associated with the presence of an RPE rip.
  3. GA contiguous with peripapillary atrophy.
  4. Active CNV secondary to wet AMD in the study eye and currently receiving anti-VEGF ocular treatment within the previous 18 months.
  5. Subretinal fibrosis in the macula from CNV both clinically and imaged on SD-OCT in the macula.
  6. 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.
  7. 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.
  8. 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.
  9. Active acute or chronic infectious uveitis, retinitis, or conjunctivitis (excluding blepharitis)
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Responsible Party: Hemera Biosciences
ClinicalTrials.gov Identifier: NCT04358471    
Other Study ID Numbers: HMR-2001
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: May 10, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Macular Degeneration
Geographic Atrophy
Atrophy
Retinal Degeneration
Retinal Diseases
Eye Diseases
Pathological Conditions, Anatomical