Skip to main content
OpenTrials
Completed

NCT Number: NCT06038968

Methotrexate Infusion and Intrasilicone Injection During Diabetic Vitrectomy

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetic Retinopathy Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Endocrine System Diseases Eye Diseases Retinal Diseases Vascular Diseases Vitreomacular Traction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

ophthalmology department, Minia university hospital

Minya, Minya Governorate, 61519, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Methotrexate 25 MG/ML

Drug

Methotrexate is a folate derivative that inhibits several enzymes responsible for nucleotide synthesis. This inhibition leads to suppression of inflammation as well as prevention of cell division.

Other names: Methotrexate Mylan 50 mg/2 mL

parsplana vitrectomy

Procedure

Pars plana vitrectomy (PPV) is a technique in vitreoretinal surgery that enables access to the posterior segment for treating tractional retinal detachment in advanced proliferative diabetic retinopathy, in a controlled, closed system.

Primary outcomes

  1. assess retinal layers by optical coherence tomography

    Time frame: one month after pars plana vitrectomy and one month after silicone oil evacuation

    presence of epiretinal membrane, cystic changes in retina, central macular thickens

  2. assess functional outcomes by multifocal electroretinogram

    Time frame: one month after pars plana vitrectomy and one month after silicone oil evacuation

    latency and amplitude of main P wave

Secondary outcomes

  1. Anterior segment slit lamp biomicroscopic examination

    Time frame: one month after pars plana vitrectomy

    assess anterior segment inflammation as iritis or posterior synechia

  2. visual acuity

    Time frame: one month after pars plana vitrectomy and one month after silicone oil evacuation

    by logMAR (Logarithm of the Minimum Angle of Resolution)

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study title

Anatomical and Functional Outcomes of Use of Methotrexate Infusion and Intrasilicone Injection During Diabetic Vitrectomy

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Sep 15, 2023
Registry last updated
Feb 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.