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

NCT ID: NCT04358471

Last Updated: 2021-05-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-31
• Study Completion Date: 2023-09-01

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.

Conditions

Dry Age-related Macular Degeneration; Geographic Atrophy; Gene Therapy; Intravitreal Injection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intravitreal AAVCAGsCD59 1.071x10e12 vg Injection

Intravitreal AAVACGsCD59 at a dose of 1.071x10e12 vg administered once on Day 0

Group Type: ACTIVE_COMPARATOR

Intravitreal AAVCAGsCD59

Intervention Type: BIOLOGICAL

AAVCAGsCD59 is administered as an intravitreal injection in the enrolled eye

Intravitreal AAVCAGsCD59 3.56x10e11 vg Injection

Intravitreal AAVACGsCD59 at a dose of 3.56x10e11 vg administered once on Day 0

Group Type: ACTIVE_COMPARATOR

Intravitreal AAVCAGsCD59

Intervention Type: BIOLOGICAL

AAVCAGsCD59 is administered as an intravitreal injection in the enrolled eye

Sham Intravitreal Injection

Intravitreal Sham injection administered once on Day 0

Group Type: SHAM_COMPARATOR

Intravitreal Sham Injection

Intervention Type: OTHER

Sham injection mimics a real injection in the enrolled eye

Interventions

Intravitreal AAVCAGsCD59

AAVCAGsCD59 is administered as an intravitreal injection in the enrolled eye

Intervention Type: BIOLOGICAL

Intravitreal Sham Injection

Sham injection mimics a real injection in the enrolled eye

Intervention Type: OTHER

Other Intervention Names

HMR59; Sham

Eligibility 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)

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hemera Biosciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

HMR-2001

Identifier Type: -

Identifier Source: org_study_id