Efficacy and Safety Study of Ixoberogene Soroparvovec (Ixo-vec) in Participants With Neovascular Age-Related Macular Degeneration

Conditions

• Neovascular Age-Related Macular Degeneration (nAMD)
• Wet AMD

Eligibility Criteria

Sex

ALL

Age

50 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ixo-vec — GENETIC
  Ixo-vec will be administered intravitreally.
• Aflibercept — DRUG
  Aflibercept will be administered intravitreally.

Study Details

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.

Key Dates

Start date

Feb 28, 2025

Status verified

May 2026

Primary completion

Dec 22, 2026

Completion

Nov 23, 2030

Study Design

Enrollment

311 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Ixo-vec
  Participants will receive 3 monthly loading doses of aflibercept 2 mg IVT, a single IVT injection of Ixo-vec 6 x 10\^10 vg/eye at Week 1, and sham injections every 8 weeks
• Active Comparator: Aflibercept
  Participants will receive 3 monthly loading doses of aflibercept 2 mg IVT, a sham injection at Week 1, and aflibercept 2 mg IVT every 8 weeks.

Primary Outcome Measure

Mean change from Baseline in Best-Corrected Visual Acuity (BCVA) based on an average at Weeks 52 and 56 [ Time Frame: Baseline, Week 52 and Week 56 ]

Locations (75)

Find similar trials in Gilbert, AZ

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