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Anti-metabolites

Methotrexate for Retinal Detachment (FIXER Trial)

Phase 2

Recruiting

Research Sponsored by Cincinnati Eye Institute, Southwest Ohio

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Age <18 years-old

Pregnant patients or patients of childbearing 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 12

Summary

This trial aims to investigate whether methotrexate can prevent a condition called proliferative vitreoretinopathy (PVR) after surgery for retinal detachment. They will include adult patients over

Who is the study for?

Adults over 18 undergoing primary retinal detachment surgery at Cincinnati Eye Institute who can consent. Excluded are those under 18, pregnant or not using contraception for 12 weeks post-surgery, with eye infections/trauma, chronic detachment, prior retinal surgeries (except pneumatic retinopexy), Grade C PVR, methotrexate contraindications like allergy or breastfeeding.

What is being tested?

The FIXER trial is testing if methotrexate prevents scarring after retina surgery. Patients are randomly put into four groups: some get methotrexate in an infusion and as injections; others get a placebo injection with/without the methotrexate infusion.

What are the potential side effects?

Methotrexate may cause eye irritation or discomfort, increased risk of infection in the eye, potential impact on liver function and blood cell counts when absorbed systemically. Side effects vary among individuals.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am under 18 years old.

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I am not pregnant or willing to use birth control during and after my eye surgery.

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I have had a serious eye infection, injury, or trauma.

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I have severe retinal scarring.

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I am able to understand and consent to my treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Measure

Secondary study objectives

Complications

Incidence of PVR

Time to Re-detachment from PVR

+3 more

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Injection groupExperimental Treatment1 Intervention

receiving standard surgery without intraoperative methotrexate followed by postoperative 400µg intravitreal methotrexate injections 1, 3, 6, and 10 weeks after surgery.

Group II: Infusion GroupExperimental Treatment1 Intervention

receiving surgery with intraoperative intraocular methotrexate infusion as described above and postoperative sham injections.

Group III: Combined Infusion/Injection groupExperimental Treatment2 Interventions

receiving both intraoperative intraocular methotrexate infusion and postoperative 400µg intravitreal methotrexate injections 1, 3, 6, and 10 weeks after surgery.

Group IV: Control GroupPlacebo Group1 Intervention

receiving no methotrexate

0 / 5Eligibility criteria met