A Phase 2 Study to Assess the Safety and Efficacy of Intravitreal ONL1204 Ophthalmic Solution in Subjects With Mac-off Retinal Detachment

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

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.

Study Overview

• Status: Completed
• Conditions: Rhegmatogenous Retinal Detachment - Macula Off
• Intervention / Treatment: Drug: ONL1204 Ophthalmic Solution; Drug: Sham treatment

• Study Type: Interventional
• Enrollment (Actual): 136
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85020
      • Associated Retina Consultants
    • Tucson, Arizona, United States, 85704
      • Retina Associates SW PC
  • California
    • Arcadia, California, United States, 91006
      • Win Retina
    • Glendale, California, United States, 91204
      • Global Research Management, Inc.
    • Huntington Beach, California, United States, 92647
      • Salehi Retina Institute, Inc.
  • Florida
    • Jacksonville, Florida, United States, 32216
      • Florida Retina Institute
    • Lakeland, Florida, United States, 33805
      • Florida Retina Consultants
    • Pensacola, Florida, United States, 32503
      • Retina Specialty Institute
    • Saint Petersburg, Florida, United States, 33711
      • Retina Vitreous Associates of Florida
    • Sarasota, Florida, United States, 34239
      • Sarasota Retina Institute
    • Wesley Chapel, Florida, United States, 33544
      • Retina Specialists of Tampa
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Marietta Eye Clinic
  • Illinois
    • Elmhurst, Illinois, United States, 60126
      • Retina Associates, Ltd
    • Elmhurst, Illinois, United States, 60126
      • Retina Associates, Ltd.
  • Indiana
    • Carmel, Indiana, United States, 46290
      • Midwest Eye Institute
  • Maryland
    • Hagerstown, Maryland, United States, 21740
      • Cumberland Valley Retina Consultants
  • Michigan
    • Ann Arbor, Michigan, United States, 48105
      • University of Michigan Kellogg Eye Center
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Missouri
    • Saint Louis, Missouri, United States, 63144
      • The Retina Institute
  • New York
    • Liverpool, New York, United States, 13088
      • Retina Vitreous Surgeons of CNY, PC
    • Rochester, New York, United States, 14620
      • Retina Associates of Western NY, PC
  • Ohio
    • Cincinnati, Ohio, United States, 45202
      • Velocity Clinical Research, Inc.
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University - Casey Eye Institute
  • Pennsylvania
    • Erie, Pennsylvania, United States, 16507
      • Erie Retina Research, LLC
  • South Carolina
    • Ladson, South Carolina, United States, 29456
      • Charleston Neuroscience Institute
    • West Columbia, South Carolina, United States, 29169
      • Palmetto Retina Center, LLC
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57108
      • Opthalmology Ltd
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • Southeastern Retina Associates
    • Germantown, Tennessee, United States, 38138
      • Charles Retina Institute
  • Texas
    • Abilene, Texas, United States, 79606
      • Retina Research Institute of Texas
    • Austin, Texas, United States, 78705
      • Austin Research Center for Retina
    • Beaumont, Texas, United States, 77707
      • Retina Consultants of Texas
    • McAllen, Texas, United States, 78503
      • Valley Retina Institute, P.A.
    • San Antonio, Texas, United States, 78215
      • San Antonio Eye Center
    • The Woodlands, Texas, United States, 77384
      • Retina Consultants of Texas
  • Washington
    • Silverdale, Washington, United States, 98383
      • Retina Center NW, PLLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Group A; ONL1204 Ophthalmic Solution Dose A administered by intravitreal injection	Drug: ONL1204 Ophthalmic Solution; ONL1204 Ophthalmic Solution at one of two doses delivered via intravitreal injection
Experimental: Treatment Group B; ONL1204 Ophthalmic Solution Dose B administered by intravitreal injection	Drug: ONL1204 Ophthalmic Solution; ONL1204 Ophthalmic Solution at one of two doses delivered via intravitreal injection
Sham Comparator: Treatment Group C; Sham injection is performed by touching the eye surface with a syringe without a needle	Drug: Sham treatment; Sham injection is performed by touching the eye surface with a syringe without a needle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean area under the log contrast sensitivity function (AULCSF)	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.	Week 24

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: ONL Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2023
• Primary Completion (Actual): February 21, 2024
• Study Completion (Actual): February 21, 2024

Study Registration Dates

• First Submitted: February 7, 2023
• First Submitted That Met QC Criteria: February 7, 2023
• First Posted (Actual): February 15, 2023

Study Record Updates

• Last Update Posted (Estimated): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Eye Diseases; Retinal Diseases; Retinal Detachment; Dissociative Disorders; Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: ONL1204-RRD-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No