Table of contents
- Trial overview
- Study design and comparison treatment
- Who can participate
- What the trial measures
- Trial status and size
Trial overview
The available trial data for ZUNIBERGENE ROCPARVOVEC describe one Phase 3 study in adults with macular neovascularization secondary to age-related macular degeneration, also called nAMD.[1] The study is interventional, which means people in the trial receive a study treatment and are then followed to see what happens.[1]
The trial is authorised and plans to include 480 participants.[1] Its main purpose is to evaluate efficacy, safety, and durability of the study treatment in this eye disease.[1]
Study design and comparison treatment
This study is described as randomized, double-masked, and active-controlled.[1] Randomized means treatment groups are assigned by chance, double-masked means neither the participants nor the study team know which treatment is being given, and active-controlled means the study compares against another active treatment rather than no treatment.[1]
The trial compares a single intravitreal injection of ZUNIBERGENE ROCPARVOVEC with aflibercept given every 8 weeks.[1] Intravitreal means the treatment is injected into the eye.[1]
The source data also state that the main efficacy goal is to show non-inferiority to aflibercept.[1] Non-inferiority means the new treatment should not perform meaningfully worse than the comparison treatment by more than a set amount.[1]
Who can participate
The trial is studying adults with nAMD.[1] The data provided do not list the full inclusion or exclusion criteria, so the exact rules for joining the study are not available in the source material.[1]
Because the condition is eye-related, the study is focused on people whose vision may be affected by abnormal blood vessel growth in the macula.[1] The macula is the part of the retina needed for sharp central vision.[1]
What the trial measures
The primary outcome is the mean change from baseline in BCVA ETDRS letter score at Week 52.[1] BCVA means best corrected visual acuity, which is a standard way to measure vision with the best possible correction, such as glasses.[1]
ETDRS letter score is a research eye-chart score used to measure vision changes more precisely than a simple yes-or-no vision result.[1] Baseline means the starting point before treatment, and Week 52 means the assessment after one year.[1]
The trial brief summary says the study also looks at safety and durability.[1] Durability means how long the treatment effect lasts over time.[1]
Trial status and size
The trial status is Authorised.[1] This means the study has been approved to move forward in the source registry information.[1]
The planned enrollment is 480 adults.[1] A larger enrollment helps researchers compare outcomes more reliably across the study groups.[1]
