Status:
RECRUITING
Prevention of ProliFerative Vitreoretinopathy with Intravitreal MethotreXate in Primary Retinal DEtachment Repair (FIXER) Trial
Lead Sponsor:
Cincinnati Eye Institute, Southwest Ohio
Conditions:
Proliferative Vitreoretinopathy
Rhegmatogenous Retinal Detachment
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Detailed Description
I. Title Prevention of ProliFerative Vitreoretinopathy with Intravitreal MethotreXate in Primary Retinal DEtachment Repair (FIXER) Trial IV. General Study Information ing on the surgeon and technique...
Eligibility Criteria
Inclusion
- • 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
- 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.
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
860 Patients enrolled
Trial Details
Trial ID
NCT06541574
Start Date
March 1 2024
End Date
June 1 2026
Last Update
September 19 2024
Active Locations (1)
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1
Cincinnati Eye Institute
Cincinnati, Ohio, United States, 45242