Prevention of ProliFerative Vitreoretinopathy with Intravitreal MethotreXate in Primary Retinal DEtachment Repair (FIXER) Trial

Launched by CINCINNATI EYE INSTITUTE, SOUTHWEST OHIO · Aug 2, 2024

Keywords

ClinConnect Summary

The FIXER Trial is investigating whether a medication called methotrexate can help prevent a condition known as Proliferative Vitreoretinopathy (PVR) after surgery to repair a specific type of retinal detachment called rhegmatogenous retinal detachment. PVR can occur after such surgeries and may lead to vision problems. This study is looking for adult participants, aged 18 and older, who are undergoing this type of surgery at the Cincinnati Eye Institute. Certain individuals, such as those with a history of severe eye trauma or previous retinal repairs, may not be eligible to join.

Participants in the trial will be randomly assigned to one of four groups, and neither the patients nor the doctors will know which group they are in during the study. Some will receive methotrexate during and after their surgery, while others will receive a placebo (a treatment that looks like the real one but has no active ingredients). The goal is to see if methotrexate can effectively reduce the risk of developing PVR and improve outcomes after the surgery. If you or someone you know might be interested in participating, please contact Dr. Christopher D. Riemann at the Cincinnati Eye Institute for more information.

Gender

ALL

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.