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Clinical trial

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

ID
Name
MTX DM vitrectomy
Description
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.
Trial arms
Trial start
2022-09-01
Estimated PCD
2023-11-01
Trial end
2024-01-01
Status
Completed
Phase
Early phase I
Treatment
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.
Arms:
Methotrexate group
Other names:
Methotrexate Mylan 50 mg/2 mL
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.
Arms:
Control group, Methotrexate group
Size
60
Primary endpoint
assess retinal layers by optical coherence tomography
one month after pars plana vitrectomy and one month after silicone oil evacuation
assess functional outcomes by multifocal electroretinogram
one month after pars plana vitrectomy and one month after silicone oil evacuation
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}
Updated at
2024-02-05

1 organization

1 product

2 indications

Organization
Minia University
Product
Methotrexate
Indication
Diabetic Retinopathy
Indication
Vitreomacular Traction