Repeated Methotrexate for Proliferative Vitreoretinopathy Grade C

Phase 2

• Conditions: Proliferative Vitreoretinopathy
• Interventions: Drug: Methotrexate

• Registration Number: NCT04482543
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-07
• Study First Submitted: 2020-07-18
• Study First Submitted QC: 2020-07-18
• Last Update Submitted: 2020-07-18
• Study First Posted: 2020-07-22
• Last Update Posted: 2020-07-22
• Study Start: 2020-08-01
• Primary Completion: 2021-07-01
• Study Completion: 2021-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 74

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intra-silicone oil injection of 250 µg methotrexate	Methotrexate	-

Primary Outcome Measures

Name	Time	Method
Retinal reattachment rate	6 months	Funduscopy

Secondary Outcome Measures

Name	Time	Method
Best corrected visual acuity	6 months	Snellen chart
Adverse events	6 months	Slit-lamp, tonometry and funduscopy
Retinal reproliferation rate	6 months	Funduscopy

Trial Locations

Locations (1)

Ophthalmic Research Center; 🇮🇷 Tehran, Iran, Islamic Republic of