NCT06541574 Prevention of ProliFerative Vitreoretinopathy with Intravitreal MethotreXate in Primary Retinal DEtachment Repair (FIXER) Trial
| NCT ID | NCT06541574 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Cincinnati Eye Institute, Southwest Ohio |
| Condition | Proliferative Vitreoretinopathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 860 participants |
| Start Date | 2024-03-01 |
| Primary Completion | 2025-06 |
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.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 860 participants in total. It began in 2024-03-01 with a primary completion date of 2025-06.
⚠ 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
I. Title Prevention of ProliFerative Vitreoretinopathy with Intravitreal MethotreXate in Primary Retinal DEtachment Repair (FIXER) Trial * Today's Date: September 18, 2023 II. Principal Investigator * Principal Investigator: Christopher D. Riemann, M.D. (Cincinnati Eye Institute) * Email: criemann@cvphealth.com, Phone: 513-708-1979 V. Research Summary Purpose: To evaluate methotrexate for the prevention of PVR after primary rhegmatogenous retinal detachment repair. Methods: Inclusion Criteria: • Any adult patient, age ≥18 years-old, undergoing primary rhegmatogenous retinal detachment surgery with pars plana vitrectomy at the Cincinnati Eye Institute in Blue Ash, Ohio who is able to give informed consent. Exclusion Criteria: * Age \<18 years old * Pregnant patients or patients of child bearing potential unwilling to utilize long term contraception for the 12-week period spanning vitrectomy surgery for retinal detachment repair up until the 3 month postoperative visit. * History of endophthalmitis, ruptured globe or significant trauma in the affected eye * Chronic retinal detachment (symptoms greater than or equal to six weeks) * Any previous previous retinal detachment repair with pars plana vitrectomy, or scleral buckling surgery. Patients having undergone previous pneumatic retinopexy will not be excluded. * Presence of Grade C PVR: full thickness retinal folds or subretinal bands * Patients with contraindications to methotrexate, including breastfeeding, pregnancy, attempting to conceive a child or any known hypersensitivity or intolerance to methotrexate * Patients with diminished mental capacity precluding their ability to give informed consent. Study Design and Randomization This prospective double masked trial will randomize patients into four groups in a 1:1:1:1 fashion. All attending surgeons and patients will be masked to group randomization. Randomization into four groups will occur on the day of surgery by the Cincinnati Eye Institute's pharmacist, Deepali Chachare. Group A will consist of ≥ 150 patients receiving intraoperative infusion with balanced salt solution containing methotrexate (40mg/500mL BSS), and methotrexate intravitreal injections (400mcg/0.05mL) at postoperative weeks 1, 3, 6, and 10. Group B will consist of ≥ 150 patients receiving intraoperative balanced salt solution infusion containing methotrexate, and sham intravitreal injections at postoperative weeks 1, 3, 6, and 10. Group C will consist of ≥ 150 patients receiving a balanced salt solution infusion without methotrexate, and methotrexate injections at postoperative weeks 1, 3, 6, and 10. Group D will consist of ≥ 150 patients receiving intraoperative balanced salt solution infusion without methotrexate, and sham intravitreal injections at postoperative weeks 1, 3, 6, and 10.
Eligibility Criteria
Inclusion Criteria: • Any adult patient, age \> 18 years-old, undergoing primary rhegmatogenous retinal detachment surgery with pars plana vitrectomy at the Cincinnati Eye Institute in Blue Ash, Ohio who is able to give informed consent. Exclusion Criteria: * Age \<18 years-old * Pregnant patients or patients of child bearing potential unwilling to utilize long term contraception for the 12-week period spanning vitrectomy surgery for retinal detachment repair up until the 3 month postoperative visit. * History of endophthalmitis, ruptured globe or significant trauma in the affected eye * Chronic retinal detachment (symptoms \> six weeks) * Any previous previous retinal detachment repair with pars plana vitrectomy, or scleral buckling surgery. Patients having undergone previous pneumatic retinopexy will not be excluded. * Presence of Grade C PVR: full thickness retinal folds or subretinal bands * Patients with contraindications to methotrexate, including breastfeeding, pregnancy, attempting to conceive a child or any known hypersensitivity or intolerance to methotrexate * Patients with diminished mental capacity precluding their ability to give informed consent.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06541574 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Proliferative Vitreoretinopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06541574 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06541574 currently recruiting?
Yes, NCT06541574 is actively recruiting participants. Contact the research team at criemann@cvphealth.com for enrollment information.
Where is the NCT06541574 trial being conducted?
This trial is being conducted at Cincinnati, United States.
Who is sponsoring the NCT06541574 clinical trial?
NCT06541574 is sponsored by Cincinnati Eye Institute, Southwest Ohio. The trial plans to enroll 860 participants.