Rhegmatogenous Retinal Detachment - Macula OffPhase 2NCT05730218
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 study testing ONL1204 Ophthalmic Solution in people with Rhegmatogenous Retinal Detachment - Macula Off, run by ONL Therapeutics at 36 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rhegmatogenous Retinal Detachment - Macula Off
- What is being tested?
- ONL1204 Ophthalmic Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 36 sitesUnited States
- Study dates
- 4 Apr 2023to 21 Feb 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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)
Who cannot join
- 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
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- 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
- Vitreous hemorrhage or cataract in the SE that prohibits adequate examination for other exclusion criteria, per Investigator's discretion
- 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
- Ocular malignancy
- Proliferative diabetic retinopathy or diabetic macular edema or uveitis
- Currently participating in other clinical trials or use of any other investigational drugs or devices within 12 weeks prior to Visit 1
- 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)
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
United States36 sites
Retina Research Institute of Texas
Abilene, Texas, 79606
University of Michigan Kellogg Eye Center
Ann Arbor, Michigan, 48105
Win Retina
Arcadia, California, 91006
Austin Research Center for Retina
Austin, Texas, 78705
Retina Consultants of Texas
Beaumont, Texas, 77707
Midwest Eye Institute
Carmel, Indiana, 46290
Southeastern Retina Associates
Chattanooga, Tennessee, 37421
Velocity Clinical Research, Inc.
Cincinnati, Ohio, 45202
Retina Associates, Ltd.
Elmhurst, Illinois, 60126
Retina Associates, Ltd
Elmhurst, Illinois, 60126
Erie Retina Research, LLC
Erie, Pennsylvania, 16507
Charles Retina Institute
Germantown, Tennessee, 38138
Global Research Management, Inc.
Glendale, California, 91204
Cumberland Valley Retina Consultants
Hagerstown, Maryland, 21740
Salehi Retina Institute, Inc.
Huntington Beach, California, 92647
Florida Retina Institute
Jacksonville, Florida, 32216
Charleston Neuroscience Institute
Ladson, South Carolina, 29456
Florida Retina Consultants
Lakeland, Florida, 33805
Retina Vitreous Surgeons of CNY, PC
Liverpool, New York, 13088
Marietta Eye Clinic
Marietta, Georgia, 30060
Valley Retina Institute, P.A.
McAllen, Texas, 78503
Retina Specialty Institute
Pensacola, Florida, 32503
Associated Retina Consultants
Phoenix, Arizona, 85020
Oregon Health & Science University - Casey Eye Institute
Portland, Oregon, 97239
Mayo Clinic
Rochester, Minnesota, 55905
Retina Associates of Western NY, PC
Rochester, New York, 14620
San Antonio Eye Center
San Antonio, Texas, 78215
Sarasota Retina Institute
Sarasota, Florida, 34239
Retina Center NW, PLLC
Silverdale, Washington, 98383
Opthalmology Ltd
Sioux Falls, South Dakota, 57108
The Retina Institute
St Louis, Missouri, 63144
Retina Vitreous Associates of Florida
St. Petersburg, Florida, 33711
Retina Consultants of Texas
The Woodlands, Texas, 77384
Retina Associates SW PC
Tucson, Arizona, 85704
Retina Specialists of Tampa
Wesley Chapel, Florida, 33544
Palmetto Retina Center, LLC
West Columbia, South Carolina, 29169
About this study
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
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.
- Being tested
- ONL1204 Ophthalmic Solution, Sham treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONL1204 Ophthalmic SolutionDrug
ONL1204 Ophthalmic Solution at one of two doses delivered via intravitreal injection
Sham treatmentDrug
Sham injection is performed by touching the eye surface with a syringe without a needle
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group A | Experimental | ONL1204 Ophthalmic Solution Dose A administered by intravitreal injection Receives: Drug: ONL1204 Ophthalmic Solution |
| Treatment Group B | Experimental | ONL1204 Ophthalmic Solution Dose B administered by intravitreal injection Receives: Drug: ONL1204 Ophthalmic Solution |
| Treatment Group C | Sham comparator | Sham injection is performed by touching the eye surface with a syringe without a needle Receives: Drug: Sham treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 24
Secondary outcomes (3)
AULCSF
Measured: Week 12
Mean best-corrected visual acuity (BCVA) measured in logarithm of the minimum angle of resolution (logMAR)
Measured: Week 12
BCVA
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start4 Apr 2023
- Primary completion21 Feb 2024
- Study completion21 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhegmatogenous Retinal Detachment - Macula OffStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- ONL Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05730218
- Sponsor's protocol ID
- ONL1204-RRD-002
- Status last verified
- Feb 2024
- First submitted
- 7 Feb 2023
- Last updated
- 29 Feb 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05730218
- Acronym / sponsor ID
- ONL1204-RRD-002
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- ONL TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 4 Apr 2023 (actual)
- Primary completion
- 21 Feb 2024 (actual)
- Study completion
- 21 Feb 2024 (actual)
- First posted
- 15 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment Group A | Experimental | Drug: ONL1204 Ophthalmic SolutionONL1204 Ophthalmic Solution Dose A administered by intravitreal injection |
| Treatment Group B | Experimental | Drug: ONL1204 Ophthalmic SolutionONL1204 Ophthalmic Solution Dose B administered by intravitreal injection |
| Treatment Group C | Sham comparator | Drug: Sham treatmentSham injection is performed by touching the eye surface with a syringe without a needle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (20 listed)
- Presence of a complex retinal detachment (RD) in the SE, identified by one or more of the following:
- Use of silicone oil tamponade in the primary RD repair without planned removal by end of study
- Vitreous hemorrhage or cataract in the SE that prohibits adequate examination for other exclusion criteria, per Investigator's discretion
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ONL1204 Ophthalmic SolutionONL1204 Ophthalmic Solution at one of two doses delivered via intravitreal injection | Drug | Treatment Group A, Treatment Group B |
| Sham treatmentSham injection is performed by touching the eye surface with a syringe without a needle | Drug | Treatment Group C |
Primary outcome
Mean area under the log contrast sensitivity function (AULCSF)
Time frame: Week 24
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.
3 secondary outcomes
AULCSF
Time frame: Week 12
Mean best-corrected visual acuity (BCVA) measured in logarithm of the minimum angle of resolution (logMAR)
Time frame: Week 12
BCVA
Time frame: Week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
36 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ONL1204 Ophthalmic Solution in people with Rhegmatogenous Retinal Detachment - Macula Off, run by ONL Therapeutics at 36 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean area under the log contrast sensitivity function (AULCSF) (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2024.