This is a multi-center, randomized, double-masked, active-comparator-controlled, Phase 3 study in a broad participant population (treatment-naïve and treatment-experienced) with neovascular (wet) age-related macular degeneration (nAMD). The study will evaluate a single intravitreal (IVT) injection of Ixo-vec compared to intravitreal aflibercept (active comparator). The primary endpoint of this study is the mean change in best corrected visual acuity (BCVA) of Ixo-vec compared to an active comparator measured as an average at Weeks 52 and 56.
Safety, tolerability, and efficacy will be evaluated throughout the study.
Able and willing to provide informed consent (or have a legally authorized representative who is able and willing to provide informed consent) prior to any study assessments and procedures and comply with the study requirements and visits.
Male or female with a diagnosis of CNV secondary to nAMD in the study eye, with nAMD disease activity at Screening Visit 1.
At least 50 years old at Screening Visit 1.
An ETDRS BCVA letter score of 35 - 78 (approximate Snellen equivalent of 20/200 to 20/32) in the study eye at Screening Visit 1.
History of a medical condition giving reasonable suspicion of a condition that contraindicates the use of Ixo-vec, compromises the participant's ability to comply with the planned study activities, or that might affect the interpretation of the results of the study or render the participant at high risk for treatment complications in the opinion of the Investigator. History of severe coronavirus disease (COVID-19) infection may meet this exclusion criterion if, in the opinion of the Investigator, it is likely to lead to any important complications.
Received any prior gene therapy.
Prior treatment with any non-gene therapy investigational medicinal product (IMP) or medical device in the study eye within 3 months of Screening Visit 1 or 5 half-lives of the IMP prior to dosing with Ixo-vec, whichever is longer.
Female participants who are pregnant or breastfeeding or who intend to become pregnant or breastfeed in the future.
Parallel
Ixo-vec
GeneticIxo-vec will be administered intravitreally.
Aflibercept
DrugAflibercept will be administered intravitreally.
Mean Change from Baseline in BCVA Based on an Average at Weeks 52 and 56
BCVA will be measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart.
Mean Number of Aflibercept IVT Injections Received
Percentage of Participants with Worsened BCVA
BCVA measured by ETDRS.
Percentage of Participants with Improved BCVA
BCVA measured by ETDRS.
Mean Change from Baseline in BCVA Over Time Based on an Average at Weeks 52 and 56
BCVA measured by ETDRS.
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