NCT05730218

A Phase 2 Study to Assess the Safety and Efficacy of Intravitreal ONL1204 Ophthalmic Solution in Subjects With Mac-off Retinal Detachment

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: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: ONL Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rhegmatogenous Retinal Detachment - Macula Off

Interventions

Type	Name	Description
DRUG	ONL1204 Ophthalmic Solution	ONL1204 Ophthalmic Solution at one of two doses delivered via intravitreal injection
DRUG	Sham treatment	Sham injection is performed by touching the eye surface with a syringe without a needle

Timeline

• Start date: 2023-04-04
• Primary completion: 2024-02-21
• Completion: 2024-02-21
• First posted: 2023-02-15
• Last updated: 2024-02-29

Locations

36 sites across 1 country: United States

Regulatory

• FDA-regulated drug study