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

NCT06541574 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 860

Last updated 2024-09-19

No results posted yet for this 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: [email protected], 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 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.

Conditions

  • Proliferative Vitreoretinopathy
  • Rhegmatogenous Retinal Detachment

Interventions

DRUG

Methotrexate Injection

Methotrexate injection

DRUG

Methotrexate Infusion

Methotrexate Infusion

DRUG

Sham Injection

Sham Injection

Sponsors & Collaborators

  • Cincinnati Eye Institute, Southwest Ohio

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-01
Primary Completion
2025-06-30
Completion
2026-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06541574 on ClinicalTrials.gov