Preventing vision loss after retinal detachment surgery with methotrexate
Official title: Prevention of ProliFerative Vitreoretinopathy With Intravitreal MethotreXate in Primary Retinal DEtachment Repair (FIXER) Trial
Run by Cincinnati Eye Institute, Southwest Ohio · NCT06541574 · Data updated 2026-11-12
This study is testing if a medication called methotrexate can help prevent vision loss from complications after retinal detachment surgery in adults.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 860 (estimated) |
| Sponsor | Cincinnati Eye Institute, Southwest Ohio Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Cincinnati, Ohio) |
| Status | Recruiting |
| Started | March 1, 2024 |
| Main results expected | December 2028 |
| Study ends | December 2028 |
| Registry record updated | October 29, 2026 |
| Trial ID | NCT06541574 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older undergoing primary rhegmatogenous retinal detachment surgery.
✕Probably not a fit
Patients with a history of significant eye trauma or previous retinal detachment repairs may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the effectiveness of intravitreal methotrexate in preventing proliferative vitreoretinopathy (PVR) following primary rhegmatogenous retinal detachment repair. The study involves adult patients undergoing pars plana vitrectomy at the Cincinnati Eye Institute, where they will receive either methotrexate or a sham injection. Data will be collected on various risk factors and surgical details to assess the outcomes related to PVR formation. The goal is to determine if methotrexate can reduce the incidence of PVR, which complicates retinal detachment surgeries.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the risk of vision loss due to PVR after retinal detachment surgery.
How similar studies have gone: While the use of methotrexate in this context is novel, similar approaches in other studies have shown promise in managing PVR.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Cincinnati Eye Institute
Cincinnati, Ohio, United States Recruiting
Study contacts
- Study coordinator: Christopher Riemann, MD
- Email: criemann@cvphealth.com
- Phone: 513-708-1979
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.