Methotrexate Infusion and Intrasilicone Injection During Diabetic Vitrectomy

February 2, 2024 updated by: Abdallah Mohsen Mohamed Safwat, Minia University

Anatomical and Functional Outcomes of Use of 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Minia
      • Minya, Minia, Egypt, 61519
        • ophthalmology department, Minia university hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Methotrexate group
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
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.
Other Names:
  • Methotrexate Mylan 50 mg/2 mL
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.
Placebo Comparator: Control group
control group will not receive MTX in irrigation fluid during vitrectomy nor intra-silicone at the end of vitrectomy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
one month after pars plana vitrectomy and one month after silicone oil evacuation
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
one month after pars plana vitrectomy and one month after silicone oil evacuation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anterior segment slit lamp biomicroscopic examination
Time Frame: one month after pars plana vitrectomy
assess anterior segment inflammation as iritis or posterior synechia
one month after pars plana vitrectomy
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)
one month after pars plana vitrectomy and one month after silicone oil evacuation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minia University

Investigators

  • Study Chair: Rabie MM Hasanin, Professor, ophthalmology department, faculty of medicine, Minia university hospital
  • Study Director: Khaled MS morad, Professor, ophthalmology department, faculty of medicine, Minia university hospital
  • Study Director: Ahmed MA Shawkat, Professor, ophthalmology department, faculty of medicine, Minia university hospital
  • Study Director: Mohamed Tarek AM Mostafa, Ass. Prof., ophthalmology department, faculty of medicine, Minia university hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Actual)

November 1, 2023

Study Completion (Actual)

January 1, 2024

Study Registration Dates

First Submitted

September 8, 2023

First Submitted That Met QC Criteria

September 8, 2023

First Posted (Actual)

September 15, 2023

Study Record Updates

Last Update Posted (Estimated)

February 5, 2024

Last Update Submitted That Met QC Criteria

February 2, 2024

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MTX DM vitrectomy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

email the main investigator for requested data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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