Clinical trial NCT04358471: Intravitreal AAVCAGsCD59 for Advanced Dry Age-related Macular Degeneration (AMD) With Geographic Atrophy (GA)
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)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Dry Age-related Macular Degeneration
Geographic Atrophy
Gene Therapy
Intravitreal Injection
Lead sponsor: Hemera Biosciences
Sponsor class: INDUSTRY
First posted: 2020-04-24
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be assigned to low dose AAVCAGsCD59, high dose AAVCAGsCD59, or sham arm.
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Evaluate the change in Geographic Atrophy area (mm2) measured at Day 0 and compared to the measurement at Month 24
timeFrame: 24 Months
Secondary outcomes:
measure: Incidence of conversion from dry to wet age-related macular degeneration
timeFrame: 24 Months
measure: Change in visual acuity of the AAVCAGsCD59 treated eye
timeFrame: 24 Months
Other outcomes:
Locations:
Study officials:
References: