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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: July 1, 2023

Interventions

  • 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

Arms, Groups and Cohorts

  • Active Comparator: Intravitreal AAVCAGsCD59 1.071x10e12 vg Injection
    • Intravitreal AAVACGsCD59 at a dose of 1.071x10e12 vg administered once on Day 0
  • Active Comparator: Intravitreal AAVCAGsCD59 3.56x10e11 vg Injection
    • Intravitreal AAVACGsCD59 at a dose of 3.56x10e11 vg administered once on Day 0
  • Sham Comparator: Sham Intravitreal Injection
    • Intravitreal Sham injection administered once on Day 0

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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
  • 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

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 65 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hemera Biosciences
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Adam Rogers, MD, 857-302-3027, arogers@hemerabiosciences.com

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.