A Phase 2 Study to Assess the Safety and Efficacy of Intravitreal ONL1204 Ophthalmic Solution in Subjects With Mac-off Retinal Detachment
Public ClinicalTrials.gov record NCT05730218. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT05730218
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 136 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 4, 2023 (Actual)
- Primary completion
- Feb 21, 2024 (Actual)
- Completion
- Feb 21, 2024 (Actual)
- Last update posted
- Feb 29, 2024
2023 – 2024
United States locations
- U.S. sites
- 36
- U.S. states
- 19
- U.S. cities
- 35
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Associated Retina Consultants | Phoenix | Arizona | 85020 | — |
| Retina Associates SW PC | Tucson | Arizona | 85704 | — |
| Win Retina | Arcadia | California | 91006 | — |
| Global Research Management, Inc. | Glendale | California | 91204 | — |
| Salehi Retina Institute, Inc. | Huntington Beach | California | 92647 | — |
| Florida Retina Institute | Jacksonville | Florida | 32216 | — |
| Florida Retina Consultants | Lakeland | Florida | 33805 | — |
| Retina Specialty Institute | Pensacola | Florida | 32503 | — |
| Sarasota Retina Institute | Sarasota | Florida | 34239 | — |
| Retina Vitreous Associates of Florida | St. Petersburg | Florida | 33711 | — |
| Retina Specialists of Tampa | Wesley Chapel | Florida | 33544 | — |
| Marietta Eye Clinic | Marietta | Georgia | 30060 | — |
| Retina Associates, Ltd. | Elmhurst | Illinois | 60126 | — |
| Retina Associates, Ltd | Elmhurst | Illinois | 60126 | — |
| Midwest Eye Institute | Carmel | Indiana | 46290 | — |
| Cumberland Valley Retina Consultants | Hagerstown | Maryland | 21740 | — |
| University of Michigan Kellogg Eye Center | Ann Arbor | Michigan | 48105 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| The Retina Institute | St Louis | Missouri | 63144 | — |
| Retina Vitreous Surgeons of CNY, PC | Liverpool | New York | 13088 | — |
| Retina Associates of Western NY, PC | Rochester | New York | 14620 | — |
| Velocity Clinical Research, Inc. | Cincinnati | Ohio | 45202 | — |
| Oregon Health & Science University - Casey Eye Institute | Portland | Oregon | 97239 | — |
| Erie Retina Research, LLC | Erie | Pennsylvania | 16507 | — |
| Charleston Neuroscience Institute | Ladson | South Carolina | 29456 | — |
| Palmetto Retina Center, LLC | West Columbia | South Carolina | 29169 | — |
| Opthalmology Ltd | Sioux Falls | South Dakota | 57108 | — |
| Southeastern Retina Associates | Chattanooga | Tennessee | 37421 | — |
| Charles Retina Institute | Germantown | Tennessee | 38138 | — |
| Retina Research Institute of Texas | Abilene | Texas | 79606 | — |
| Austin Research Center for Retina | Austin | Texas | 78705 | — |
| Retina Consultants of Texas | Beaumont | Texas | 77707 | — |
| Valley Retina Institute, P.A. | McAllen | Texas | 78503 | — |
| San Antonio Eye Center | San Antonio | Texas | 78215 | — |
| Retina Consultants of Texas | The Woodlands | Texas | 77384 | — |
| Retina Center NW, PLLC | Silverdale | Washington | 98383 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05730218, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 29, 2024 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05730218 live on ClinicalTrials.gov.