Rhegmatogenous Retinal Detachment - Macula Off
Conditions
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.
Interventions
ONL1204 Ophthalmic Solution at one of two doses delivered via intravitreal injection
DRUGSham treatment
Sham injection is performed by touching the eye surface with a syringe without a needle
Sponsors
ONL Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult subject, ≥18 years old at the time of informed consent 2. Able and willing to give informed consent and comply with all study visits and procedures 3. 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) 4. 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 5. Visual acuity with subject's current corrective lenses or pinhole of 20/200 (line scoring) or better in the fellow eye 6. Determination by Investigator of macula-off status by clinical examination with confirmation by SD-OCT or B-scan ultrasound, if available. 7. SOC retinal reattachment surgery by means of a pars plana vitrectomy (with or without scleral buckle) is indicated 8. In the opinion of the Investigator, can safely undergo the IVT injection procedure at Baseline (Visit 2) 9. 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
1. Presence of a complex retinal detachment (RD) in the SE, identified by one or more of the following: 1. Giant retinal tear, defined as retinal break ≥3 clock hours in extent 2. Proliferative vitreoretinopathy grade C1 or worse on the Retina Society Terminology Committee Classification System 3. Presence of tractional detachments as seen in proliferative retinopathies 4. RRD in the setting of open- or closed-globe trauma 5. RRD following endophthalmitis or infectious retinitis 6. Similarly complex RD as determined by the Investigator 2. Use of silicone oil tamponade in the primary RD repair without planned removal by end of study 3. Vitreous hemorrhage or cataract in the SE that prohibits adequate examination for other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| AULCSF | Week 12 |
| Mean best-corrected visual acuity (BCVA) measured in logarithm of the minimum angle of resolution (logMAR) | Week 12 |
| BCVA | Week 24 |
Countries
United States
Outcome results
None listed