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

Conditions

• Rhegmatogenous Retinal Detachment - Macula Off

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed

Feb 15, 2023

Start date

Apr 4, 2023

Status verified

Feb 2024

Primary completion

Feb 21, 2024

Completion

Feb 21, 2024

Study Design

Enrollment

136 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Treatment Group A
  ONL1204 Ophthalmic Solution Dose A administered by intravitreal injection
• Experimental: Treatment Group B
  ONL1204 Ophthalmic Solution Dose B administered by intravitreal injection
• Sham Comparator: Treatment Group C
  Sham injection is performed by touching the eye surface with a syringe without a needle

Primary Outcome Measure

Mean area under the log contrast sensitivity function (AULCSF) [ Time Frame: Week 24 ]

Locations (36)

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