Methotrexate Infusion and Intrasilicone Injection During Diabetic Vitrectomy

NCT06038968 | Completed Early Phase 1

• 1 other identifier: MTX DM vitrectomy
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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?

Conditions

Diabetic Retinopathy; Vitreomacular Traction

Keywords

Methotrexate; proliferative diabetic retinopathy

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Anterior segment slit lamp biomicroscopic examination

  one month after pars plana vitrectomy

• visual acuity

  one month after pars plana vitrectomy and one month after silicone oil evacuation

Study Arms (2)

Methotrexate group

EXPERIMENTAL

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; Procedure: parsplana vitrectomy

Control group

PLACEBO COMPARATOR

control group will not receive MTX in irrigation fluid during vitrectomy nor intra-silicone at the end of vitrectomy

Procedure: parsplana vitrectomy

Interventions

Methotrexate 25 MG/ML DRUG

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.

Also known as: Methotrexate Mylan 50 mg/2 mL

Methotrexate group

parsplana vitrectomy PROCEDURE

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.

Control group; Methotrexate group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

ophthalmology department, Minia university hospital

Minya, Minya Governorate, 61519, Egypt

Location

Related Publications (8)

• Newman DK. Surgical management of the late complications of proliferative diabetic retinopathy. Eye (Lond). 2010 Mar;24(3):441-9. doi: 10.1038/eye.2009.325. Epub 2010 Feb 5.

  PMID: 20139916 BACKGROUND

• Meleth AD, Carvounis PE. Outcomes of vitrectomy for tractional retinal detachment in diabetic retinopathy. Int Ophthalmol Clin. 2014 Spring;54(2):127-39. doi: 10.1097/IIO.0000000000000021. No abstract available.

  PMID: 24613889 BACKGROUND

• Gologorsky D, Thanos A, Vavvas D. Therapeutic interventions against inflammatory and angiogenic mediators in proliferative diabetic retinopathy. Mediators Inflamm. 2012;2012:629452. doi: 10.1155/2012/629452. Epub 2012 Sep 17.

  PMID: 23028203 BACKGROUND

• Zhou J, Wang S, Xia X. Role of intravitreal inflammatory cytokines and angiogenic factors in proliferative diabetic retinopathy. Curr Eye Res. 2012 May;37(5):416-20. doi: 10.3109/02713683.2012.661114. Epub 2012 Mar 12.

  PMID: 22409294 BACKGROUND

• Ricker LJ, Kijlstra A, Kessels AG, de Jager W, Liem AT, Hendrikse F, La Heij EC. Interleukin and growth factor levels in subretinal fluid in rhegmatogenous retinal detachment: a case-control study. PLoS One. 2011 Apr 27;6(4):e19141. doi: 10.1371/journal.pone.0019141.

  PMID: 21556354 BACKGROUND

• Samson CM, Waheed N, Baltatzis S, Foster CS. Methotrexate therapy for chronic noninfectious uveitis: analysis of a case series of 160 patients. Ophthalmology. 2001 Jun;108(6):1134-9. doi: 10.1016/s0161-6420(01)00576-0.

  PMID: 11382642 BACKGROUND

• Smith JR, Rosenbaum JT, Wilson DJ, Doolittle ND, Siegal T, Neuwelt EA, Pe'er J. Role of intravitreal methotrexate in the management of primary central nervous system lymphoma with ocular involvement. Ophthalmology. 2002 Sep;109(9):1709-16. doi: 10.1016/s0161-6420(02)01125-9.

  PMID: 12208721 BACKGROUND

• Amarnani D, Machuca-Parra AI, Wong LL, Marko CK, Stefater JA, Stryjewski TP, Eliott D, Arboleda-Velasquez JF, Kim LA. Effect of Methotrexate on an In Vitro Patient-Derived Model of Proliferative Vitreoretinopathy. Invest Ophthalmol Vis Sci. 2017 Aug 1;58(10):3940-3949. doi: 10.1167/iovs.16-20912.

  PMID: 28777835 BACKGROUND

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Rabie MM Hasanin, Professor

  ophthalmology department, faculty of medicine, Minia university hospital

  STUDY CHAIR

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer, ophthalmology department, faculty of medicine

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: September 15, 2023
• Study Start: September 1, 2022
• Primary Completion: November 1, 2023
• Study Completion: January 1, 2024
• Last Updated: February 5, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)