Methotrexate for Retinal Detachment
(FIXER Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinator or your doctor.
What data supports the effectiveness of the drug Methotrexate for retinal detachment?
Is methotrexate safe for use in treating retinal detachment?
How is the drug methotrexate unique for treating retinal detachment?
Methotrexate is unique for treating retinal detachment because it is used as an intravitreal (injected into the eye) agent to prevent and treat proliferative vitreoretinopathy (PVR), a complication that can occur after retinal detachment surgery. This approach is different from standard treatments as it directly targets the eye to reduce the risk of PVR, which is not typically addressed by other treatments.12345
What is the purpose of this trial?
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: 513-708-1979V. Research SummaryPurpose: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.
Eligibility Criteria
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.Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Surgery
Vitrectomy surgery for retinal detachment repair is performed with randomization into one of four study groups
Postoperative Treatment
Participants receive either methotrexate or sham injections at weeks 1, 3, 6, and 10 post-surgery
Follow-up
Participants are monitored for safety and effectiveness, including visual acuity and presence of PVR, up to 12 months post-surgery
Treatment Details
Interventions
- Methotrexate
- Sham Injection
Methotrexate is already approved in United States, Canada, European Union for the following indications:
- Acute lymphoblastic leukemia
- Non-Hodgkin's lymphoma
- Osteosarcoma
- Breast cancer
- Lung cancer
- Head and neck cancer
- Psoriasis
- Rheumatoid arthritis
- Acute lymphoblastic leukemia
- Non-Hodgkin's lymphoma
- Osteosarcoma
- Breast cancer
- Lung cancer
- Head and neck cancer
- Psoriasis
- Rheumatoid arthritis
- Acute lymphoblastic leukemia
- Non-Hodgkin's lymphoma
- Osteosarcoma
- Breast cancer
- Lung cancer
- Head and neck cancer
- Psoriasis
- Rheumatoid arthritis
- Crohn's disease
- Ulcerative colitis
Find a Clinic Near You
Who Is Running the Clinical Trial?
Cincinnati Eye Institute, Southwest Ohio
Lead Sponsor