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

Rhegmatogenous Retinal Detachment - Macula Off Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05730218
• Other study ID #: ONL1204-RRD-002
• Status: Completed
• Phase: Phase 2
• Start date: April 4, 2023
• Est. completion date: February 21, 2024

Study information

• Verified date: February 2024
• Source: ONL Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: February 21, 2024
• Est. primary completion date: February 21, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Dissociative Disorders
• Retinal Detachment
• Rhegmatogenous Retinal Detachment - Macula Off

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	Retina Research Institute of Texas	Abilene	Texas
United States	University of Michigan Kellogg Eye Center	Ann Arbor	Michigan
United States	Win Retina	Arcadia	California
United States	Austin Research Center for Retina	Austin	Texas
United States	Retina Consultants of Texas	Beaumont	Texas
United States	Midwest Eye Institute	Carmel	Indiana
United States	Southeastern Retina Associates	Chattanooga	Tennessee
United States	Velocity Clinical Research, Inc.	Cincinnati	Ohio
United States	Retina Associates, Ltd	Elmhurst	Illinois
United States	Retina Associates, Ltd.	Elmhurst	Illinois
United States	Erie Retina Research, LLC	Erie	Pennsylvania
United States	Charles Retina Institute	Germantown	Tennessee
United States	Global Research Management, Inc.	Glendale	California
United States	Cumberland Valley Retina Consultants	Hagerstown	Maryland
United States	Salehi Retina Institute, Inc.	Huntington Beach	California
United States	Florida Retina Institute	Jacksonville	Florida
United States	Charleston Neuroscience Institute	Ladson	South Carolina
United States	Florida Retina Consultants	Lakeland	Florida
United States	Retina Vitreous Surgeons of CNY, PC	Liverpool	New York
United States	Marietta Eye Clinic	Marietta	Georgia
United States	Valley Retina Institute, P.A.	McAllen	Texas
United States	Retina Specialty Institute	Pensacola	Florida
United States	Associated Retina Consultants	Phoenix	Arizona
United States	Oregon Health & Science University - Casey Eye Institute	Portland	Oregon
United States	Mayo Clinic	Rochester	Minnesota
United States	Retina Associates of Western NY, PC	Rochester	New York
United States	The Retina Institute	Saint Louis	Missouri
United States	Retina Vitreous Associates of Florida	Saint Petersburg	Florida
United States	San Antonio Eye Center	San Antonio	Texas
United States	Sarasota Retina Institute	Sarasota	Florida
United States	Retina Center NW, PLLC	Silverdale	Washington
United States	Opthalmology Ltd	Sioux Falls	South Dakota
United States	Retina Consultants of Texas	The Woodlands	Texas
United States	Retina Associates SW PC	Tucson	Arizona
United States	Retina Specialists of Tampa	Wesley Chapel	Florida
United States	Palmetto Retina Center, LLC	West Columbia	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
ONL Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	AULCSF		Week 12
Secondary	Mean best-corrected visual acuity (BCVA) measured in logarithm of the minimum angle of resolution (logMAR)		Week 12
Secondary	BCVA		Week 24