Efficacy and Safety Study of Ixoberogene Soroparvovec (Ixo-vec) in Participants With Neovascular … (NCT06856577) | Clinical Trial Compass
RecruitingPhase 3
Efficacy and Safety Study of Ixoberogene Soroparvovec (Ixo-vec) in Participants With Neovascular Age-Related Macular Degeneration
United States284 participantsStarted 2025-02-28
Plain-language summary
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 an 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 at an average of Weeks 52 and 56.
Safety, tolerability, and efficacy will be evaluated throughout the study.
Who can participate
Age range50 Years
SexALL
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Inclusion criteria
✓. 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 Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA letter score of 35 - 78 (approximate Snellen equivalent of 20/200 to 20/32) in the study eye at Screening Visit 1.
✓. Demonstrated a meaningful anatomic response to anti-VEGF therapy during screening
✓. Able to reliably use eye drops per protocol
Exclusion criteria
✕. 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 criteria if, in the opinion of the Investigator, it is likely to lead to any important complications.
What they're measuring
1
Mean change from Baseline in Best-Corrected Visual Acuity (BCVA) based on an average at Weeks 52 and 56
✕. 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.
✕. History or evidence of any of the following cardiovascular diseases:
✕. Myocardial infarction in the 6-month period prior to Week 1.
✕. Uncontrolled hypertension defined as systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg during screening.
✕. Stroke in the 6-month period prior to Week 1.