Repeated Methotrexate for Proliferative Vitreoretinopathy Grade C

Shahid Beheshti University of Medical Sciences

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Proliferative Vitreoretinopathy

Treatments: Drug: Methotrexate

Study type: Interventional

Funder types: Other

Identifiers

NCT04482543

23454

Details and patient eligibility

About

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.

Enrollment: 74 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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74 participants in 2 patient groups

Intra-silicone oil injection of 250 µg methotrexate

Active Comparator group

Treatment:

Drug: Methotrexate

No intra-silicone oil injection of methotrexate

No Intervention group