Overview

A Phase 2, Randomized, Sham-Controlled, Single-Masked, Dose-Ranging, Multi-Center Study to Assess the Safety and Efficacy of Intravitreal ONL1204 Ophthalmic Solution in Subjects With Macula-off Rhegmatogenous Retinal Detachment

Status:
Not yet recruiting

Trial end date:
2025-05-01

Target enrollment:

Participant gender:

Summary

The goal of this Phase 2 clinical trial is to learn about ONL1204 Ophthalmic Solution in terms of safety and how well the drug works in patients that have a macula-off (central point of vision) rhegmatogenous retinal detachment (RRD). The main questions it aims to answer are: - Does ONL1204 improve vision in macula-off RRD patients when used before retinal detachment repair surgery compared to patients that have surgery alone? - Is ONL1204 safe to use as an add-on drug before retinal repair surgery? Researchers will observe patients that receive two different dosages of ONL1204 Ophthalmic Solution (50 µg or 200 µg) compared to current standard therapy (no treatment) to see if there are differences in vision and safety outcomes.

Phase:

Phase 2

Details

Lead Sponsor:

ONL Therapeutics

Treatments:

Ophthalmic Solutions