Prevention of ProliFerative Vitreoretinopathy With Intravitreal MethotreXate in Primary Retinal DEtachment Repair (FIXER) Trial
NCT Number: NCT06541574
Acronym: FIXER
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Proliferative Vitreoretinopathy|Rhegmatogenous Retinal Detachment
Interventions: DRUG: Methotrexate Injection|DRUG: Methotrexate Infusion|DRUG: Sham Injection
Sponsor: Cincinnati Eye Institute, Southwest Ohio
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 860
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-03-01
Completion Date: 2026-06
Locations: Cincinnati Eye Institute, Cincinnati, Ohio, 45242, United States

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 \&gt; 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 \&lt;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 \&gt; 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.

Primary Outcome Measures: Primary Outcome Measure, Percentage of patients achieving single Surgery Success rate for primary Rhegmatogenous Retinal Detachment repair in each group., Month 12
Secondary Outcome Measures: number of retinal detachment repair reoperations, Comparison of number of retinal detachment repair reoperations between study groups, 12 months|Visual Acuity, Mean final Visual Acuity within and between study groups, 12 months|Time to Re-detachment from PVR, Time to Re-detachment from PVR, 12 months|methotrexate-associated corneal epitheliopathy, number of patients developing methotrexate-associated corneal epitheliopathy, 12 months|Complications, Rate of development of complications (epiretinal membrane formation, endophthalmitis, other ophthalmic surgeries), 12 months|Incidence of PVR, Incidence of PVR amongst the study groups, 12 months