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Prevention of ProliFerative Vitreoretinopathy with Intravitreal MethotreXate in Primary Retinal DEtachment Repair (FIXER) Trial
NCT06541574 · View on ClinicalTrials.gov ↗
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06541574
The ClinicalTrials.gov registry entry for NCT06541574 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 860 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cincinnati Eye Institute, Southwest Ohio, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06541574 reports 1 study location spanning 1 distinct geographic area — top geographies include Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06541574?
The interventions under investigation include: Methotrexate Injection (DRUG), Methotrexate Infusion (DRUG), Sham Injection (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06541574?
This trial is sponsored by Cincinnati Eye Institute, Southwest Ohio, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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