Methotrexate Infusion and Intrasilicone Injection During Diabetic Vitrectomy

Early Phase 1

Completed

• Conditions: Vitreomacular Traction; Diabetic Retinopathy
• Interventions: Drug: Methotrexate 25 MG/ML; Procedure: parsplana vitrectomy

• Registration Number: NCT06038968
• Lead Sponsor: Minia University

Brief Summary

The goal of this interventional clinical trial is to assess anatomical and functional outcomes of methotrexate use in irrigating fluid during parsplana vitrectomy combined with intrasilicone injection at end of surgery in patients with advanced proliferative diabetic retinopathy.

The main questions it aims to answer are:

1. Does methotrexate use in irrigating fluid during parsplana vitrectomy combined with intrasilicone injection at end of surgery decrease the post operative vitreoretinal proliferation after vitrectomy in patients with advanced proliferative diabetic retinopathy?

2. Does methotrexate use in irrigating fluid during parsplana vitrectomy combined with intrasilicone injection at end of surgery improve post operative functional outcome after vitrectomy in patients with advanced proliferative diabetic retinopathy?

Researchers will compare the anatomical and functional outcomes after vitrectomy in patients with advanced proliferative diabetic retinopathy without using methotrexate.

Detailed Description

Tractional macular detachment (TMD) or macula threatening tractional retinal detachment (TRD) and combined tractional-rhegmatogenous retinal detachment (TRD/RRD) are considered as important indications for vitreoretinal intervention.

Although a growing number of eyes with TMD and TRD/RRD are successfully treated with a single procedure, retinal re-detachment associated with fibrovascular proliferation or proliferative vitreoretinopathy (PVR) is still a major cause of failure of the surgery.

Previous studies have shown increased expression of inflammatory cytokines and growth factors in both proliferative diabetic retinopathy (PDR) and PVR.

Methotrexate (MTX) is an anti-neoplastic and anti-inflammatory agent used to treat a variety of malignancies and rheumatologic diseases.

In ophthalmology, systemic and intraocular MTX has been successfully used for indeterminate uveitis, sarcoid uveitis and intraocular lymphoma.

MTX has been recently found to inhibit PVR by stopping cellular proliferation and promoting organized apoptosis. MTX has also been found to be effective in lowering the incidence of PVR when used as an adjunct in irrigation fluid during vitrectomy for retinal detachment.

Study Timeline

• Study Start: 2022-09-01
• Status Verified: 2023-09
• Study First Submitted: 2023-09-08
• Study First Submitted QC: 2023-09-08
• Study First Posted: 2023-09-15
• Primary Completion: 2023-11-01
• Study Completion: 2024-01-01
• Last Update Submitted: 2024-02-02
• Last Update Posted: 2024-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients with diabetic tractional macular detachment or combined tractional- rhegmatogenous retinal detachment

Exclusion Criteria

• Previous vitreoretinal surgery.
• Pregnant or lactating female.
• Co-existing pathology that might induce PVR such as penetrating ocular trauma or uveitis, co-existing congenital anomalies or hereditary vitreoretinopathies

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Methotrexate group	parsplana vitrectomy	methotrexate group will receive 40 mg of MTX in 500 ml of irrigation fluid during vitrectomy and 250 ug intra-silicone oil injection at the end of vitrectomy
Control group	parsplana vitrectomy	control group will not receive MTX in irrigation fluid during vitrectomy nor intra-silicone at the end of vitrectomy
Methotrexate group	Methotrexate 25 MG/ML	methotrexate group will receive 40 mg of MTX in 500 ml of irrigation fluid during vitrectomy and 250 ug intra-silicone oil injection at the end of vitrectomy

Primary Outcome Measures

Name	Time	Method
assess retinal layers by optical coherence tomography	one month after pars plana vitrectomy and one month after silicone oil evacuation	presence of epiretinal membrane, cystic changes in retina, central macular thickens
assess functional outcomes by multifocal electroretinogram	one month after pars plana vitrectomy and one month after silicone oil evacuation	latency and amplitude of main P wave

Secondary Outcome Measures

Name	Time	Method
Anterior segment slit lamp biomicroscopic examination	one month after pars plana vitrectomy	assess anterior segment inflammation as iritis or posterior synechia
visual acuity	one month after pars plana vitrectomy and one month after silicone oil evacuation	by logMAR (Logarithm of the Minimum Angle of Resolution)

Trial Locations

Locations (1)

ophthalmology department, Minia university hospital; 🇪🇬 Minya, Minia, Egypt