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ONL1204 in Macula-off Rhegmatogenous Retinal Detachment
NCT05730218Phase 2
Key facts
- Status
- Completed
- Start
- Apr 2023
- Primary completion
- Feb 2024
- Countries
- 1
- Sponsor
- ONL Therapeutics
- Modality
- Peptides, Small Molecules
- Drugs
- xelafaslatide
- Conditions
- rhegmatogenous retinal detachment (RRD)
01
Overview
Phase 2, randomised, single-blind trial of xelafaslatide in rhegmatogenous retinal detachment (RRD) (3 arms), sponsored by ONL Therapeutics. Primary endpoint: Mean area under the log contrast sensitivity function at Week 24. Started Apr 2023; status: completed.
02
Design
3 arms- Study design
- RandomizedSingle-blind
Treatment Group A
ONL1204 50 µg intravitreal injection
Treatment Group B
ONL1204 200 µg intravitreal injection
Treatment Group C
Sham injection
03
Who it enrols
Adult patients with macula-off rhegmatogenous retinal detachment (RRD) duration of 24 hours to 14 days, scheduled for standard pars plana vitrectomy surgery. Patients must have vision of 20/100 to light perception in the affected eye and good vision in the fellow eye. Excludes complex retinal detachments (e.g., giant tears, PVR), uncontrolled glaucoma, ocular infection, or use of silicone oil tamponade.
04
Endpoints
Primary
Mean area under the log contrast sensitivity function
Secondary
Area under the log contrast sensitivity function
Best-corrected visual acuity
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