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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06038968
Other study ID # MTX DM vitrectomy
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
Start date September 1, 2022
Est. completion date January 1, 2024

Study information

Verified date September 2023
Source Minia University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


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Study Design


Intervention

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.

Locations

Country Name City State
Egypt ophthalmology department, Minia university hospital Minya Minia

Sponsors (1)

Lead Sponsor Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

References & Publications (8)

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Outcome

Type Measure Description Time frame Safety issue
Primary assess retinal layers by optical coherence tomography presence of epiretinal membrane, cystic changes in retina, central macular thickens one month after pars plana vitrectomy and one month after silicone oil evacuation
Primary assess functional outcomes by multifocal electroretinogram latency and amplitude of main P wave one month after pars plana vitrectomy and one month after silicone oil evacuation
Secondary Anterior segment slit lamp biomicroscopic examination assess anterior segment inflammation as iritis or posterior synechia one month after pars plana vitrectomy
Secondary visual acuity by logMAR (Logarithm of the Minimum Angle of Resolution) one month after pars plana vitrectomy and one month after silicone oil evacuation
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