Repeated Methotrexate for Proliferative Vitreoretinopathy Grade C

Study Overview
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Brief Summary
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This multicenter randomized clinical trial evaluates the effect of multiple intra-silicone oil injections of methotrexate (MTX) on rhegmatogenous retinal detachment (RRD) with grade C proliferative vitreoretinopathy (PVR). 74 eyes with the diagnosis of RRD with PVR grade C will be randomized into two groups: the intervention group and the control group. All eyes undergo pars plana vitrectomy(PPV) and intraocular injection of silicone oil (SO). At the end of the surgical procedure, intra-SO injection of 250 µg MTX will be performed in the intervention group. No intra-SO injection will be done in the control group. In the intervention group, Intra-SO injection of MTX will be repeated at 3 and 6 weeks postoperatively. Silicone oil removal will be done 3 months after surgery.Spectral-domain optical coherence tomography (SD-OCT) image of the macula will be acquired at months 3 and 6. The retinal reattachment rate at months 6 will be assessed as the main outcome measure of the study. Best corrected visual acuity, retinal reproliferation rate and adverse events are the secondary outcome measures. Comprehensive ocular examination will be performed at weeks 1, 3, 6 and at months 3, 4 and 6.

Official Title
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Repeated Intra-silicone Oil Injection of Methotrexate for Management of Proliferative Vitreoretinopathy Grade C; A Multi-center Study

Conditions
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Proliferative Vitreoretinopathy

Intervention / Treatment
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* Drug: Methotrexate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Rhegmatogenous retinal detachment with proliferative vitreoretinopathy grade C Exclusion Criteria: Age of under 18 years old Pregnancy Glaucoma Macular disorders Diabetic retinopathy Retinal vascular occlusion History of penetrating ocular trauma Giant retinal tear Chronic uveitis History of intraocular steroid injection

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intra-silicone oil injection of 250 µg methotrexate<br> | Drug: Methotrexate<br>* Intra-silicone oil injection of 250 µg methotrexate is done at the end of surgery and is repeated at weeks 3 and 6 postoperatively.<br>|
| No Intervention: No intra-silicone oil injection of methotrexate<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retinal reattachment rate | Funduscopy | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best corrected visual acuity | Snellen chart | 6 months | 
| Retinal reproliferation rate | Funduscopy | 6 months | 
| Adverse events | Slit-lamp, tonometry and funduscopy | 6 months |