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NCT06541574 · ClinicalTrials.gov registry record · Phase 2
Prevention of ProliFerative Vitreoretinopathy with Intravitreal MethotreXate in Primary Retinal DEtachment Repair (FIXER) Trial
A Phase 2 study of Rhegmatogenous Retinal Detachment and Proliferative Vitreoretinopathy, sponsored by Cincinnati Eye Institute, Southwest Ohio.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 860
- Enrollment target
- 1
- Study location
NCT06541574: Recruiting Phase 2 study of Rhegmatogenous Retinal Detachment and Proliferative Vitreoretinopathy, sponsored by Cincinnati Eye Institute, Southwest Ohio.
NCT06541574 is a Phase 2 study of Rhegmatogenous Retinal Detachment and Proliferative Vitreoretinopathy that is actively recruiting participants, run by Cincinnati Eye Institute, Southwest Ohio. The registered enrollment target is 860 participants, above the 99-participant average among 3 other Rhegmatogenous Retinal Detachment trials with a reported enrollment target (769% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06541574, a Phase 2 study of Rhegmatogenous Retinal Detachment and Proliferative Vitreoretinopathy, is actively recruiting participants, sponsored by Cincinnati Eye Institute, Southwest Ohio.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 860 participants
- Enrollment target
- 1
- Study location
Study 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
Primary Outcome
Percentage of patients achieving single Surgery Success rate for primary Rhegmatogenous Retinal Detachment repair in each group.
Conditions Studied
Interventions
- DRUG Methotrexate Injection
- DRUG Methotrexate Infusion
- DRUG Sham Injection
Study Locations (1)
Ohio
- Cincinnati Eye Institute - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 860 participants |
| Start Date | 2024-03-01 |
| Est. Completion | 2026-06 |
| Phase | Phase 2 |
What NCT06541574 shows while recruiting
NCT06541574 is an interventional study that assigns participants to a tested intervention. The registered 860 participants enrollment target is mid-sized for trials with a published cap, above the 99-participant average among 3 other Rhegmatogenous Retinal Detachment trials with a reported enrollment target (769% higher).
The record links to 2 conditions, with Rhegmatogenous Retinal Detachment appearing as the primary indexed condition, and to 3 interventions - of which Methotrexate Injection is the first listed.
NCT06541574 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT06541574 about?
NCT06541574 is a clinical study titled "Prevention of ProliFerative Vitreoretinopathy with Intravitreal MethotreXate in Primary Retinal DEtachment Repair (FIXER) Trial". 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@...
What is the current status of trial NCT06541574?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 860 participants. The study started on 2024-03-01. Estimated completion is 2026-06.
What conditions does trial NCT06541574 study?
This clinical trial studies the following conditions: Rhegmatogenous Retinal Detachment, Proliferative Vitreoretinopathy.
What interventions are being tested in trial NCT06541574?
The interventions under investigation include: Methotrexate Injection (DRUG), Methotrexate Infusion (DRUG), Sham Injection (DRUG).
Who is sponsoring clinical trial NCT06541574?
This trial is sponsored by Cincinnati Eye Institute, Southwest Ohio, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06541574 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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