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NCT06038968CompletedEarly phase 1

Methotrexate Infusion and Intrasilicone Injection During Diabetic Vitrectomy

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

Source: ClinicalTrials.gov · Last updated 5 Feb 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Early phase 1
Study type
Interventional
Enrollment
60 (actual)
First submitted
8 Sept 2023
Start date
1 Sept 2022
Primary completion date
1 Nov 2023
Lead sponsor
Minia University
NCT number
NCT06038968

What you commit to

  • Study type: Interventional · Early phase 1
  • Participants enrolled: 60
  • From 1 Sept 2022 to the primary completion date, 1 Nov 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous vitreoretinal surgery.

Other

  • 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

Who the study is looking for

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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
ophthalmology department, Minia university hospital
Coordinator of this site? Confirm its status
MinyaEgyptUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.