A Phase 2 Study to Assess the Safety and Efficacy of Intravitreal ONL1204 Ophthalmic Solution in Subjects With Mac-off Retinal Detachment
NCT ID: NCT05730218
Last Updated: 2024-02-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
136 participants
INTERVENTIONAL
2023-04-04
2024-02-21
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Treatment Group A
ONL1204 Ophthalmic Solution Dose A administered by intravitreal injection
ONL1204 Ophthalmic Solution
ONL1204 Ophthalmic Solution at one of two doses delivered via intravitreal injection
Treatment Group B
ONL1204 Ophthalmic Solution Dose B administered by intravitreal injection
ONL1204 Ophthalmic Solution
ONL1204 Ophthalmic Solution at one of two doses delivered via intravitreal injection
Treatment Group C
Sham injection is performed by touching the eye surface with a syringe without a needle
Sham treatment
Sham injection is performed by touching the eye surface with a syringe without a needle
Interventions
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ONL1204 Ophthalmic Solution
ONL1204 Ophthalmic Solution at one of two doses delivered via intravitreal injection
Sham treatment
Sham injection is performed by touching the eye surface with a syringe without a needle
Eligibility Criteria
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Inclusion Criteria
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. 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
4. Presence of ocular or periocular infection or intraocular inflammation in either eye
5. Uncontrolled glaucoma, as defined by an IOP \>36 mmHg in either eye, at Screening
6. 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
7. History of previous ocular surgery in the SE for RD (excluding only barrier laser), endophthalmitis, glaucoma tube shunts, trabeculectomy, or ocular trauma
8. 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
9. History of and/or active:
1. 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
2. Ocular malignancy
3. Proliferative diabetic retinopathy or diabetic macular edema or uveitis
10. Currently participating in other clinical trials or use of any other investigational drugs or devices within 12 weeks prior to Visit 1
11. 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)
18 Years
ALL
No
Sponsors
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ONL Therapeutics
INDUSTRY
Responsible Party
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Locations
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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
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
Retina Specialists of Tampa
Wesley Chapel, Florida, United States
Marietta Eye Clinic
Marietta, Georgia, United States
Retina Associates, Ltd.
Elmhurst, Illinois, United States
Retina Associates, Ltd
Elmhurst, Illinois, United States
Midwest Eye Institute
Carmel, Indiana, United States
Cumberland Valley Retina Consultants
Hagerstown, Maryland, United States
University of Michigan Kellogg Eye Center
Ann Arbor, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
The Retina Institute
St Louis, Missouri, United States
Retina Vitreous Surgeons of CNY, PC
Liverpool, New York, United States
Retina Associates of Western NY, PC
Rochester, New York, United States
Velocity Clinical Research, Inc.
Cincinnati, Ohio, United States
Oregon Health & Science University - Casey Eye Institute
Portland, Oregon, United States
Erie Retina Research, LLC
Erie, Pennsylvania, United States
Charleston Neuroscience Institute
Ladson, South Carolina, United States
Palmetto Retina Center, LLC
West Columbia, South Carolina, United States
Opthalmology Ltd
Sioux Falls, South Dakota, United States
Southeastern Retina Associates
Chattanooga, Tennessee, 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
Retina Consultants of Texas
Beaumont, Texas, United States
Valley Retina Institute, P.A.
McAllen, Texas, United States
San Antonio Eye Center
San Antonio, Texas, United States
Retina Consultants of Texas
The Woodlands, Texas, United States
Retina Center NW, PLLC
Silverdale, Washington, United States
Countries
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Other Identifiers
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ONL1204-RRD-002
Identifier Type: -
Identifier Source: org_study_id
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