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

NCT05730218 | Completed Phase 2 FDA Drug

• 1 other identifier: ONL1204-RRD-002
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 36

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.

Conditions

Rhegmatogenous Retinal Detachment - Macula Off

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• AULCSF

  Week 12

• Mean best-corrected visual acuity (BCVA) measured in logarithm of the minimum angle of resolution (logMAR)

  Week 12

• BCVA

  Week 24

Study Arms (3)

Treatment Group A

EXPERIMENTAL

ONL1204 Ophthalmic Solution Dose A administered by intravitreal injection

Drug: ONL1204 Ophthalmic Solution

Treatment Group B

EXPERIMENTAL

ONL1204 Ophthalmic Solution Dose B administered by intravitreal injection

Drug: ONL1204 Ophthalmic Solution

Treatment Group C

SHAM COMPARATOR

Sham injection is performed by touching the eye surface with a syringe without a needle

Drug: Sham treatment

Interventions

ONL1204 Ophthalmic Solution DRUG

ONL1204 Ophthalmic Solution at one of two doses delivered via intravitreal injection

Treatment Group A; Treatment Group B

Sham treatment DRUG

Sham injection is performed by touching the eye surface with a syringe without a needle

Treatment Group C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• ONL Therapeutics: lead

Study Sites (36)

Associated Retina Consultants

Phoenix, Arizona, 85020, United States

Location

Retina Associates SW PC

Tucson, Arizona, 85704, United States

Location

Win Retina

Arcadia, California, 91006, United States

Location

Global Research Management, Inc.

Glendale, California, 91204, United States

Location

Salehi Retina Institute, Inc.

Huntington Beach, California, 92647, United States

Location

Florida Retina Institute

Jacksonville, Florida, 32216, United States

Location

Florida Retina Consultants

Lakeland, Florida, 33805, United States

Location

Retina Specialty Institute

Pensacola, Florida, 32503, United States

Location

Sarasota Retina Institute

Sarasota, Florida, 34239, United States

Location

Retina Vitreous Associates of Florida

St. Petersburg, Florida, 33711, United States

Location

Retina Specialists of Tampa

Wesley Chapel, Florida, 33544, United States

Location

Marietta Eye Clinic

Marietta, Georgia, 30060, United States

Location

Retina Associates, Ltd.

Elmhurst, Illinois, 60126, United States

Location

Retina Associates, Ltd

Elmhurst, Illinois, 60126, United States

Location

Midwest Eye Institute

Carmel, Indiana, 46290, United States

Location

Cumberland Valley Retina Consultants

Hagerstown, Maryland, 21740, United States

Location

University of Michigan Kellogg Eye Center

Ann Arbor, Michigan, 48105, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

The Retina Institute

St Louis, Missouri, 63144, United States

Location

Retina Vitreous Surgeons of CNY, PC

Liverpool, New York, 13088, United States

Location

Retina Associates of Western NY, PC

Rochester, New York, 14620, United States

Location

Velocity Clinical Research, Inc.

Cincinnati, Ohio, 45202, United States

Location

Oregon Health & Science University - Casey Eye Institute

Portland, Oregon, 97239, United States

Location

Erie Retina Research, LLC

Erie, Pennsylvania, 16507, United States

Location

Charleston Neuroscience Institute

Ladson, South Carolina, 29456, United States

Location

Palmetto Retina Center, LLC

West Columbia, South Carolina, 29169, United States

Location

Opthalmology Ltd

Sioux Falls, South Dakota, 57108, United States

Location

Southeastern Retina Associates

Chattanooga, Tennessee, 37421, United States

Location

Charles Retina Institute

Germantown, Tennessee, 38138, United States

Location

Retina Research Institute of Texas

Abilene, Texas, 79606, United States

Location

Austin Research Center for Retina

Austin, Texas, 78705, United States

Location

Retina Consultants of Texas

Beaumont, Texas, 77707, United States

Location

Valley Retina Institute, P.A.

McAllen, Texas, 78503, United States

Location

San Antonio Eye Center

San Antonio, Texas, 78215, United States

Location

Retina Consultants of Texas

The Woodlands, Texas, 77384, United States

Location

Retina Center NW, PLLC

Silverdale, Washington, 98383, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: February 15, 2023
• Study Start: April 4, 2023
• Primary Completion: February 21, 2024
• Study Completion: February 21, 2024
• Last Updated: February 29, 2024

Record last verified: 2024-02

Locations

US (36)