RGX-314 Gene Therapy Pharmacodynamic Study for Neovascular Age-related Macular Degeneration (nAMD)

Launched by ABBVIE · Apr 1, 2021

Keywords

ClinConnect Summary

Wet AMD is a significant cause of vision loss in the United States, Europe and Japan, with up to 2 million people living with wet AMD in these geographies alone. Current anti-VEGF therapies have significantly changed the landscape for treatment of wet AMD, becoming the standard of care due to their ability to prevent progression of vision loss in the majority of patients. These therapies, however, require life-long repeated intraocular injections to maintain efficacy. Due to the burden of treatment, patients often experience a decline in vision with reduced frequency of treatment over time....

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Eligibility criteria

• Inclusion Criteria:
• • 1. Males or females, aged ≥ 50 years and ≤ 89 years.
• • 2. An Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA-letter score between ≤ 78 and ≥ 40 in the study eye at Screening.
• • 3. Diagnosis of choroidal neovascularization (CNV) secondary to age-related macular degeneration in the study eye previously treated with anti-VEGF.
• • 4. Participants must have demonstrated a meaningful response to anti-VEGF therapy at study entry.
• • 5. Willing and able to provide written, signed informed consent for this study.
• • 6. Must be pseudophakic (at least 12 weeks postcataract surgery) in the study eye.
• Exclusion Criteria:
• • 1. CNV or macular edema in the study eye secondary to any causes other than AMD.
• • 2. Subfoveal fibrosis or atrophy in study eye.
• • 3. Any condition in the investigator's opinion that could limit visual acuity improvement in the study eye.
• • 4. Active or history of retinal detachment or retinal tear in the study eye.
• • 5. Advanced glaucoma in the study eye.
• • 6. Prior treatment with gene therapy.
• • 7. Myocardial infarction, cerebrovascular accident, or transient ischemic attack within the past 6 months.