A Phase 2 Study to Assess the Safety and Efficacy of Intravitreal ONL1204 Ophthalmic Solution in Subjects With Mac-off Retinal Detachment
Rhegmatogenous Retinal Detachment - Macula Off
About this trial
This is an interventional treatment trial for Rhegmatogenous Retinal Detachment - Macula Off
Eligibility Criteria
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) Surgical repair scheduled or anticipated to take place >12 hours after IVT injection or sham (Visit 2) and ≤10 days from Screening (Visit 1) Exclusion Criteria: 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)
Sites / Locations
- Associated Retina Consultants
- Retina Associates SW PC
- Win Retina
- Global Research Management, Inc.
- Salehi Retina Institute, Inc.
- Florida Retina Institute
- Florida Retina Consultants
- Retina Specialty Institute
- Retina Vitreous Associates of Florida
- Sarasota Retina Institute
- Retina Specialists of Tampa
- Marietta Eye Clinic
- Retina Associates, Ltd.
- Retina Associates, Ltd
- Midwest Eye Institute
- Cumberland Valley Retina Consultants
- University of Michigan Kellogg Eye Center
- Mayo Clinic
- The Retina Institute
- Retina Vitreous Surgeons of CNY, PC
- Retina Associates of Western NY, PC
- Velocity Clinical Research, Inc.
- Oregon Health & Science University - Casey Eye Institute
- Erie Retina Research, LLC
- Charleston Neuroscience Institute
- Palmetto Retina Center, LLC
- Opthalmology Ltd
- Southeastern Retina Associates
- Charles Retina Institute
- Retina Research Institute of Texas
- Austin Research Center for Retina
- Retina Consultants of Texas
- Valley Retina Institute, P.A.
- San Antonio Eye Center
- Retina Consultants of Texas
- Retina Center NW, PLLC
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Sham Comparator
Treatment Group A
Treatment Group B
Treatment Group C
ONL1204 Ophthalmic Solution Dose A administered by intravitreal injection
ONL1204 Ophthalmic Solution Dose B administered by intravitreal injection
Sham injection is performed by touching the eye surface with a syringe without a needle