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Methotrexate Infusion and Intrasilicone Injection During Diabetic Vitrectomy

Primary Purpose

Diabetic Retinopathy, Vitreomacular Traction

Status
Recruiting
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Methotrexate 25 MG/ML
parsplana vitrectomy
Sponsored by
Minia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetic Retinopathy focused on measuring Methotrexate, proliferative diabetic retinopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • ophthalmology department, Minia university hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Methotrexate group

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

assess retinal layers by optical coherence tomography
presence of epiretinal membrane, cystic changes in retina, central macular thickens
assess functional outcomes by multifocal electroretinogram
latency and amplitude of main P wave

Secondary Outcome Measures

Anterior segment slit lamp biomicroscopic examination
assess anterior segment inflammation as iritis or posterior synechia
visual acuity
by logMAR (Logarithm of the Minimum Angle of Resolution)

Full Information

First Posted
September 8, 2023
Last Updated
September 8, 2023
Sponsor
Minia University
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1. Study Identification

Unique Protocol Identification Number
NCT06038968
Brief Title
Methotrexate Infusion and Intrasilicone Injection During Diabetic Vitrectomy
Official Title
Anatomical and Functional Outcomes of Use of Methotrexate Infusion and Intrasilicone Injection During Diabetic Vitrectomy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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: 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? 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy, Vitreomacular Traction
Keywords
Methotrexate, proliferative diabetic retinopathy

7. Study Design

Primary Purpose
Other
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Methotrexate group
Arm Type
Experimental
Arm Description
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
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
control group will not receive MTX in irrigation fluid during vitrectomy nor intra-silicone at the end of vitrectomy
Intervention Type
Drug
Intervention Name(s)
Methotrexate 25 MG/ML
Other Intervention Name(s)
Methotrexate Mylan 50 mg/2 mL
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
parsplana vitrectomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
assess retinal layers by optical coherence tomography
Description
presence of epiretinal membrane, cystic changes in retina, central macular thickens
Time Frame
one month after pars plana vitrectomy and one month after silicone oil evacuation
Title
assess functional outcomes by multifocal electroretinogram
Description
latency and amplitude of main P wave
Time Frame
one month after pars plana vitrectomy and one month after silicone oil evacuation
Secondary Outcome Measure Information:
Title
Anterior segment slit lamp biomicroscopic examination
Description
assess anterior segment inflammation as iritis or posterior synechia
Time Frame
one month after pars plana vitrectomy
Title
visual acuity
Description
by logMAR (Logarithm of the Minimum Angle of Resolution)
Time Frame
one month after pars plana vitrectomy and one month after silicone oil evacuation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abdallah MM Safwat, ass lecturer
Phone
01092212031
Ext
02
Email
drabdallahmh@gamil.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rabie MM Hasanin, Professor
Organizational Affiliation
ophthalmology department, faculty of medicine, Minia university hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Khaled MS morad, Professor
Organizational Affiliation
ophthalmology department, faculty of medicine, Minia university hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ahmed MA Shawkat, Professor
Organizational Affiliation
ophthalmology department, faculty of medicine, Minia university hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohamed Tarek AM Mostafa, Ass. Prof.
Organizational Affiliation
ophthalmology department, faculty of medicine, Minia university hospital
Official's Role
Study Director
Facility Information:
Facility Name
ophthalmology department, Minia university hospital
City
Minya
State/Province
Minia
ZIP/Postal Code
61519
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ِAbdallah MM Safwat, Ass Lecturer
Phone
01092212031
Ext
01
Email
drabdallahmh@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
email the main investigator for requested data
Citations:
PubMed Identifier
20139916
Citation
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.
Results Reference
background
PubMed Identifier
24613889
Citation
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.
Results Reference
background
PubMed Identifier
23028203
Citation
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.
Results Reference
background
PubMed Identifier
22409294
Citation
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.
Results Reference
background
PubMed Identifier
21556354
Citation
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.
Results Reference
background
PubMed Identifier
11382642
Citation
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.
Results Reference
background
PubMed Identifier
12208721
Citation
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.
Results Reference
background
PubMed Identifier
28777835
Citation
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.
Results Reference
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Methotrexate Infusion and Intrasilicone Injection During Diabetic Vitrectomy

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