NCT07146516 Retinal Detachment Prevention (Laser Prophylaxis) in Stickler Syndrome (SS)
| NCT ID | NCT07146516 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Helen Keller Eye Research Foundation |
| Condition | Stickler Syndrome Type 1 |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2025-10-30 |
| Primary Completion | 2035-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 500 participants in total. It began in 2025-10-30 with a primary completion date of 2035-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to prospectively document to what extent the OSC/SS prophylactic laser retinopexy procedure works to prevent retinal detachment in SS in children and adults. Researchers will compare the OSC/SS procedure in SS to the natural progression of SS to see to what extent the OSC/SS procedure works to prevent retinal detachment. Participants will: * Have the OSC/SS procedure in one or both eyes * Have eye tests * Have genetic testing for SS as needed * Visit the study center 9 times over 5 years for checkups and tests * Have data for the untreated fellow-eye collected and used as study data if available
Eligibility Criteria
Inclusion Criteria: 1. No contraindications to laser retinopexy surgery per local site criteria. 2. Capable of giving signed informed consent, and assent (as appropriate) 3. Signature of research informed consent form from participant, or participant's legally authorized representative (LAR)/parent(s)/legal guardian 4. Male or female of any age 5. SS type 1 or type 2 confirmed by genetic testing Exclusion Criteria: 1. Presence of media opacity (for example, dense cataract, corneal scar) or poor pupillary dilation that precludes adequate OSC/SS performance, laser treatment, or imaging. 2. Prior prophylactic laser treatment that cannot be supplemented to achieve a complete OSC/SS pattern or exceeds the designated OSC/SS pattern. 3. RD in the eye to be treated. 4. Significant intraocular hemorrhage in the eye to be treated. 5. Uncontrolled ocular conditions (e.g., glaucoma) that may be worsened by the procedure or preclude follow-up. 6. Any other ocular condition that precludes the ability to perform adequate laser treatment under scleral depression. 7. Any systemic medical contraindication where the risk of intervention outweighs the potential benefit. 8. Known pathogenic mutations in genes associated with other inherited retinal detachment syndromes, including but not limited to: FEVR-related genes: FZD4, LRP5, TSPAN12, NDPX-linked retinoschisis (RS1) Wagner Syndrome (VCAN). 9. Other syndromes associated with increased risk of retinal detachment (for example, Knobloch syndrome, Marfan syndrome, Pierson syndrome). 10. History of Coats disease. 11. History of Retinopathy of Prematurity (with or without laser treatment). 12. Prior laser photocoagulation in the study eye for any indication other than the following: retinal detachment prophylaxis for Stickler syndrome, treatment of lattice degeneration, or treatment of retinal tears. 13. Laser photocoagulation, for the indications permitted in exclusion criteria 12, that cannot be supplemented to meet the OSC/SS criteria. 14. Previous cryopexy. 15. Previous scleral buckle. 16. Previous vitrectomy in the study eye for any reason. 17. Significant peripheral retinal pathology unrelated to Stickler that increases the risk of retinal detachment including but not limited to: retinoschisis, hemorrhages, angiomatous lesions, pars planitis. 18. History of ocular trauma with significant trauma to the posterior segment of the eye and may increase the risk of retinal detachment including Ruptured globe, Vitreous hemorrhage, Commotio retinae, Traumatic macular hole, Intraocular foreign body. 19. Inability or unwillingness to comply with required follow-up schedule (clinical visits, imaging). 20. Anticipated relocation, foster care instability, or any factor significantly limiting longitudinal follow-up. 21. Investigator judgment: Any condition not listed above that could interfere with the trial's integrity or subject safety.
Contact & Investigator
Robert E Morris, MD
STUDY DIRECTOR
Helen Keller Eye Research Foundation
Frequently Asked Questions
Who can join the NCT07146516 clinical trial?
This trial is open to participants of all sexes, studying Stickler Syndrome Type 1. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07146516 currently recruiting?
Yes, NCT07146516 is actively recruiting participants. Contact the research team at drbelin@retinamn.com for enrollment information.
Where is the NCT07146516 trial being conducted?
This trial is being conducted at Birmingham, United States, Boston, United States, Royal Oak, United States, Minneapolis, United States and 2 additional locations.
Who is sponsoring the NCT07146516 clinical trial?
NCT07146516 is sponsored by Helen Keller Eye Research Foundation. The principal investigator is Robert E Morris, MD at Helen Keller Eye Research Foundation. The trial plans to enroll 500 participants.