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
- Interventions
- Drug: ONL1204 Ophthalmic SolutionDrug: Sham treatment
- Registration Number
- NCT05730218
- Lead Sponsor
- ONL Therapeutics
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 136
- 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)
- Surgical repair scheduled or anticipated to take place >12 hours after IVT injection or sham (Visit 2) and ≤10 days from Screening (Visit 1)
-
Presence of a complex retinal detachment (RD) in the SE, identified by one or more of the following:
- Giant retinal tear, defined as retinal break ≥3 clock hours in extent
- Proliferative vitreoretinopathy grade C1 or worse on the Retina Society Terminology Committee Classification System
- Presence of tractional detachments as seen in proliferative retinopathies
- RRD in the setting of open- or closed-globe trauma
- RRD following endophthalmitis or infectious retinitis
- Similarly complex RD as determined by the Investigator
-
Use of silicone oil tamponade in the primary RD repair without planned removal by end of study
-
Vitreous hemorrhage or cataract in the SE that prohibits adequate examination for other exclusion criteria, per Investigator's discretion
-
Presence of ocular or periocular infection or intraocular inflammation in either eye
-
Uncontrolled glaucoma, as defined by an IOP >36 mmHg in either eye, at Screening
-
Any other significant ocular disease in the SE that, in the opinion of the Investigator, would preclude a postoperative (post-op) visual acuity of at least 20/30
-
History of previous ocular surgery in the SE for RD (excluding only barrier laser), endophthalmitis, glaucoma tube shunts, trabeculectomy, or ocular trauma
-
Any systemic condition or ocular condition in either eye that, in the opinion of the Investigator, makes the subject unsuitable for treatment with an investigational agent or that would compromise the safety and tolerability of assessments in the trial
-
History of and/or active:
- Autoimmune disease in active flare (i.e., not well controlled on current medications) with ocular involvement that, in the opinion of the Investigator, would impact ability to participate in the trial and/or alter the outcome of retinal reattachment surgery
- Ocular malignancy
- Proliferative diabetic retinopathy or diabetic macular edema or uveitis
-
Currently participating in other clinical trials or use of any other investigational drugs or devices within 12 weeks prior to Visit 1
-
Females who are pregnant or lactating, and women of childbearing potential (WOCBP) or men with female partners of childbearing potential who are not using at least one adequate contraceptive precaution (e.g., intrauterine device, oral contraceptive, barrier method, or other contraception deemed adequate by the Investigator)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment Group A ONL1204 Ophthalmic Solution ONL1204 Ophthalmic Solution Dose A administered by intravitreal injection Treatment Group B ONL1204 Ophthalmic Solution ONL1204 Ophthalmic Solution Dose B administered by intravitreal injection Treatment Group C Sham treatment Sham injection is performed by touching the eye surface with a syringe without a needle
- Primary Outcome Measures
Name Time Method Mean area under the log contrast sensitivity function (AULCSF) Week 24 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.
- Secondary Outcome Measures
Name Time Method Mean best-corrected visual acuity (BCVA) measured in logarithm of the minimum angle of resolution (logMAR) Week 12 AULCSF Week 12 BCVA Week 24
Trial Locations
- Locations (35)
Marietta Eye Clinic
🇺🇸Marietta, Georgia, United States
Midwest Eye Institute
🇺🇸Carmel, Indiana, United States
Charleston Neuroscience Institute
🇺🇸Ladson, South Carolina, United States
Southeastern Retina Associates
🇺🇸Chattanooga, Tennessee, United States
Retina Consultants of Texas
🇺🇸The Woodlands, Texas, United States
Retina Associates SW PC
🇺🇸Tucson, Arizona, United States
Retina Specialty Institute
🇺🇸Pensacola, Florida, United States
Sarasota Retina Institute
🇺🇸Sarasota, Florida, United States
Cumberland Valley Retina Consultants
🇺🇸Hagerstown, Maryland, United States
Florida Retina Institute
🇺🇸Jacksonville, Florida, United States
Opthalmology Ltd
🇺🇸Sioux Falls, South Dakota, United States
Palmetto Retina Center, LLC
🇺🇸West Columbia, South Carolina, United States
Salehi Retina Institute, Inc.
🇺🇸Huntington Beach, California, United States
Oregon Health & Science University - Casey Eye Institute
🇺🇸Portland, Oregon, United States
Associated Retina Consultants
🇺🇸Phoenix, Arizona, United States
Win Retina
🇺🇸Arcadia, California, United States
Global Research Management, Inc.
🇺🇸Glendale, California, United States
Florida Retina Consultants
🇺🇸Lakeland, Florida, United States
Retina Vitreous Associates of Florida
🇺🇸Saint Petersburg, Florida, United States
Retina Specialists of Tampa
🇺🇸Wesley Chapel, Florida, United States
Retina Associates, Ltd.
🇺🇸Elmhurst, Illinois, United States
Retina Associates, Ltd
🇺🇸Elmhurst, Illinois, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
The Retina Institute
🇺🇸Saint Louis, Missouri, United States
Velocity Clinical Research, Inc.
🇺🇸Cincinnati, Ohio, United States
Retina Associates of Western NY, PC
🇺🇸Rochester, New York, United States
Retina Vitreous Surgeons of CNY, PC
🇺🇸Liverpool, New York, United States
Erie Retina Research, LLC
🇺🇸Erie, Pennsylvania, United States
Charles Retina Institute
🇺🇸Germantown, Tennessee, United States
Retina Research Institute of Texas
🇺🇸Abilene, Texas, United States
Austin Research Center for Retina
🇺🇸Austin, Texas, United States
Valley Retina Institute, P.A.
🇺🇸McAllen, Texas, United States
Retina Center NW, PLLC
🇺🇸Silverdale, Washington, United States
San Antonio Eye Center
🇺🇸San Antonio, Texas, United States
University of Michigan Kellogg Eye Center
🇺🇸Ann Arbor, Michigan, United States