CompletedPhase 2

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

United States136 participantsStarted 2023-04-04

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Adult subject, ≥18 years old at the time of informed consent
✓. Able and willing to give informed consent and comply with all study visits and procedures
✓. Presentation with macula-off RRD with a duration ≥24 hours up to 14 days from time of central visual decline to the Baseline (Visit 2) visit, inclusive (based on subject reported date of loss of central vision) in the Study Eye (SE)
✓. Visual acuity with subject's current corrective lenses or pinhole of 20/100 (line scoring) on the Snellen or ETDRS chart to light perception (LP) in the SE
✓. Visual acuity with subject's current corrective lenses or pinhole of 20/200 (line scoring) or better in the fellow eye
✓. Determination by Investigator of macula-off status by clinical examination with confirmation by SD-OCT or B-scan ultrasound, if available.
✓. SOC retinal reattachment surgery by means of a pars plana vitrectomy (with or without scleral buckle) is indicated
✓. In the opinion of the Investigator, can safely undergo the IVT injection procedure at Baseline (Visit 2)

Exclusion criteria

What they're measuring

Mean area under the log contrast sensitivity function (AULCSF)

Timeframe: Week 24

Trial details

NCT IDNCT05730218

SponsorONL Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-02-21

View on ClinicalTrials.gov More Rhegmatogenous Retinal Detachment - Macula Off trials