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

Geographic Atrophy Clinical Trial

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04358471
• Other study ID #: HMR-2001
• Status: Withdrawn
• Phase: Phase 2
• Start date: July 31, 2021
• Est. completion date: September 1, 2023

Study information

• Verified date: May 2021
• Source: Hemera Biosciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

Biological:
• Intravitreal AAVCAGsCD59
AAVCAGsCD59 is administered as an intravitreal injection in the enrolled eye

Other:
• Intravitreal Sham Injection
Sham injection mimics a real injection in the enrolled eye

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hemera Biosciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the change in Geographic Atrophy area (mm2) measured at Day 0 and compared to the measurement at Month 24	Geographic atrophy will be measured based on imaging of the retina	24 Months
Secondary	Incidence of conversion from dry to wet age-related macular degeneration	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
Secondary	Change in visual acuity of the AAVCAGsCD59 treated eye	Visual acuity measured on an Early Treatment Diabetic Retinopathy Study (ETDRS) chart will be compared at Day 0 and Month 24	24 Months