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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
136
ONL1204 Ophthalmic Solution at one of two doses delivered via intravitreal injection
Sham injection is performed by touching the eye surface with a syringe without a needle
Associated Retina Consultants
Phoenix, Arizona, United States
Retina Associates SW PC
Tucson, Arizona, United States
Win Retina
Arcadia, California, United States
Global Research Management, Inc.
Glendale, California, United States
Salehi Retina Institute, Inc.
Huntington Beach, California, United States
Mean area under the log contrast sensitivity function (AULCSF)
Mean AULCSF as measured with the Adaptive Sensory Technology (AST) Manifold Contrast Vision Meter at Week 24 for subjects who do not have primary surgical failure.
Time frame: Week 24
AULCSF
Time frame: Week 12
Mean best-corrected visual acuity (BCVA) measured in logarithm of the minimum angle of resolution (logMAR)
Time frame: Week 12
BCVA
Time frame: Week 24
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Florida Retina Institute
Jacksonville, Florida, United States
Florida Retina Consultants
Lakeland, Florida, United States
Retina Specialty Institute
Pensacola, Florida, United States
Sarasota Retina Institute
Sarasota, Florida, United States
Retina Vitreous Associates of Florida
St. Petersburg, Florida, United States
...and 26 more locations