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Methotrexate Infusion and Intrasilicone Injection During Diabetic Vitrectomy

NCT06038968 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-02-05

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Methotrexate 25 MG/ML

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.

PROCEDURE

parsplana vitrectomy

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.

Sponsors & Collaborators

  • Minia University

    lead OTHER

Principal Investigators

  • Rabie MM Hasanin, Professor · ophthalmology department, faculty of medicine, Minia university hospital

  • Khaled MS morad, Professor · ophthalmology department, faculty of medicine, Minia university hospital

  • Ahmed MA Shawkat, Professor · ophthalmology department, faculty of medicine, Minia university hospital

  • Mohamed Tarek AM Mostafa, Ass. Prof. · ophthalmology department, faculty of medicine, Minia university hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2023-11-01
Completion
2024-01-01

Countries

  • Egypt

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06038968 on ClinicalTrials.gov