Clinical trial NCT05730218: A Phase 2 Study to Assess the Safety and Efficacy of Intravitreal ONL1204 Ophthalmic Solution in Subjects With Mac-off Retinal Detachment
Official title: A Phase 2, Randomized, Sham-Controlled, Single-Masked, Dose-Ranging, Multi-Center Study to Assess the Safety and Efficacy of Intravitreal ONL1204 Ophthalmic Solution in Subjects With Macula-off Rhegmatogenous Retinal Detachment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rhegmatogenous Retinal Detachment - Macula Off
Lead sponsor: ONL Therapeutics
Sponsor class: INDUSTRY
First posted: 2023-02-15
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 exclusion criteria, per Investigator's discretion
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)

Primary outcomes:
measure: Mean area under the log contrast sensitivity function (AULCSF)
timeFrame: Week 24
Secondary outcomes:
measure: AULCSF
timeFrame: Week 12
measure: Mean best-corrected visual acuity (BCVA) measured in logarithm of the minimum angle of resolution (logMAR)
timeFrame: Week 12
measure: BCVA
timeFrame: Week 24
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Associated Retina Consultants
state: Arizona
city: Tucson
country: United States
facility: Retina Associates SW PC
state: Arizona
city: Arcadia
country: United States
facility: Win Retina
state: California
city: Glendale
country: United States
facility: Global Research Management, Inc.
state: California
city: Huntington Beach
country: United States
facility: Salehi Retina Institute, Inc.
state: California
city: Jacksonville
country: United States
facility: Florida Retina Institute
state: Florida
city: Lakeland
country: United States
facility: Florida Retina Consultants
state: Florida
city: Pensacola
country: United States
facility: Retina Specialty Institute
state: Florida
city: Saint Petersburg
country: United States
facility: Retina Vitreous Associates of Florida
state: Florida
city: Sarasota
country: United States
facility: Sarasota Retina Institute
state: Florida
city: Wesley Chapel
country: United States
facility: Retina Specialists of Tampa
state: Florida
city: Marietta
country: United States
facility: Marietta Eye Clinic
state: Georgia
city: Elmhurst
country: United States
facility: Retina Associates, Ltd.
state: Illinois
city: Elmhurst
country: United States
facility: Retina Associates, Ltd
state: Illinois
city: Carmel
country: United States
facility: Midwest Eye Institute
state: Indiana
city: Hagerstown
country: United States
facility: Cumberland Valley Retina Consultants
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan Kellogg Eye Center
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: The Retina Institute
state: Missouri
city: Liverpool
country: United States
facility: Retina Vitreous Surgeons of CNY, PC
state: New York
city: Rochester
country: United States
facility: Retina Associates of Western NY, PC
state: New York
city: Cincinnati
country: United States
facility: Velocity Clinical Research, Inc.
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University - Casey Eye Institute
state: Oregon
city: Erie
country: United States
facility: Erie Retina Research, LLC
state: Pennsylvania
city: Ladson
country: United States
facility: Charleston Neuroscience Institute
state: South Carolina
city: West Columbia
country: United States
facility: Palmetto Retina Center, LLC
state: South Carolina
city: Sioux Falls
country: United States
facility: Opthalmology Ltd
state: South Dakota
city: Chattanooga
country: United States
facility: Southeastern Retina Associates
state: Tennessee
city: Germantown
country: United States
facility: Charles Retina Institute
state: Tennessee
city: Abilene
country: United States
facility: Retina Research Institute of Texas
state: Texas
city: Austin
country: United States
facility: Austin Research Center for Retina
state: Texas
city: Beaumont
country: United States
facility: Retina Consultants of Texas
state: Texas
city: McAllen
country: United States
facility: Valley Retina Institute, P.A.
state: Texas
city: San Antonio
country: United States
facility: San Antonio Eye Center
state: Texas
city: The Woodlands
country: United States
facility: Retina Consultants of Texas
state: Texas
city: Silverdale
country: United States
facility: Retina Center NW, PLLC
state: Washington
Study officials:
References: