"Comparing Methotrexate Usage Techniques to Prevent Proliferative Vitreoretinopaty After Retinal Detachment Vitrectomy"

NCT06289205 | Recruiting Phase 1 DMC

• 1 other identifier: 60/IRB/SLMC/SWL
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial, involving participants with rhegmatogenous retinal detachment, aims to compare Methotrexate Usage Techniques in preventing Proliferative Vitreoretinopathy (PVR) after vitrectomy. The study will evaluate the development of PVR, retinal detachment recurrence, and improvement in visual acuity. Participants will undergo retinal detachment surgery using the vitrectomy technique and will be divided into two groups. One group will receive Methotrexate infusion during surgery, while the other will receive repeated Methotrexate injections post-surgery. The researcher will analyze and compare outcomes between the two groups.

Conditions

Proliferative Vitreoretinopathy

Keywords

Methotrexate; Retinal detachment; Vitrectomy; Proliferative Vitreoretinopathy

Outcome Measures

Primary Outcomes (2)

• Development of Proliferative Vitreoretinopathy (PVR)

  Clinically evident PVR membrane formation

  Within three months of Vitrectomy surgery

• Recurrence of Retinal Detachment

  Re detachment of retina after retinal detachment repair surgery by vitrectomy

  Within three months of Vitrectomy surgery

Secondary Outcomes (1)

• Visual Acuity Improvement

  Final visual acuity will be measured at completion of 3 month follow up or meeting the primary outcome, whichever is earlier.

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Group 1 will be regarded as control group and per operative methotrexate infusion will be used by mixing 75 mg of methotrexate into one litre of BSS solution.

Drug: Methotrexate

Group 2

EXPERIMENTAL

Group 2 will be regarded as the study group and will receive 500 µg of intra-silicon oil methotrexate at the end of the surgery and then at 1st, 2nd, 3rd , 4th and 6th post operative weeks.

Drug: Methotrexate

Interventions

Methotrexate DRUG

Methotrexate will be utilised in two different ways to prevent development of proliferative vitreoretinopathy after vitrectomy for rhegmatogenous retinal detachment

Also known as: Antimetabolite

Group 1; Group 2

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Rhegmatogenous Retinal Detachment

You may not qualify if:

• Presence of proliferative vitreoretinopathy grade C, previous retinal detachment surgery in the same eye, penetrating ocular trauma, Presence of intraocular foreign bodies, previous glaucoma filtration surgery, allergy to methotrexate, and pregnant and lactating women.

Sponsors & Collaborators

• University of Health Sciences Lahore: lead

Study Sites (1)

Sahiwal Medical College & Teaching Hospital, Sahiwal, Pakistan

Sahiwal, Punjab Province, 57000, Pakistan

RECRUITING

Related Publications (3)

• Nagpal M, Chaudhary P, Wachasundar S, Eltayib A, Raihan A. Management of recurrent rhegmatogenous retinal detachment. Indian J Ophthalmol. 2018 Dec;66(12):1763-1771. doi: 10.4103/ijo.IJO_1212_18.

  PMID: 30451176 RESULT

• El Baha S, Leila M, Amr A, Lolah MMA. Anatomical and Functional Outcomes of Vitrectomy with/without Intravitreal Methotrexate Infusion for Management of Proliferative Vitreoretinopathy Secondary to Rhegmatogenous Retinal Detachment. J Ophthalmol. 2021 Jul 20;2021:3648134. doi: 10.1155/2021/3648134. eCollection 2021.

  PMID: 34336257 RESULT

• Jahangir S, Jahangir T, Ali MH, Lateef Q, Hamza U, Tayyab H. Use of Intravitreal Methotrexate Infusion in Complicated Retinal Detachment for Prevention of Proliferative Vitreoretinopathy in a Pilot Study. Cureus. 2021 Aug 25;13(8):e17439. doi: 10.7759/cureus.17439. eCollection 2021 Aug.

  PMID: 34462712 RESULT

MeSH Terms

Conditions

Vitreoretinopathy, Proliferative; Retinal Detachment

Interventions

Methotrexate; Antimetabolites

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Noxae; Toxic Actions

Study Officials

• Ahmad Z Jamil, FCPS,FRCS

  Sahiwal Medical College, Sahiwal, Pakistan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmad Z Jamil, FCPS,FRCS

CONTACT

+923334853851; ahmadzeeshandr@gmail.com

Muhammad H Jamil, FRCS,FCPS

CONTACT

+923336113166; dr.m.hannan@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This will be a single-blind study in which the subjects will be unaware of the intervention. Blinding will be maintained by ensuring that subjects are unaware of the dosing regimens they are receiving.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Ophthalmology

Model Details: Using lottery methods patients will be divided into two groups with 60 subjects in each group. Group 1 will be regarded as control group and per operative methotrexate infusion will be used by mixing 75 mg of methotrexate into one litre of BSS solution. Group 2 will be regarded as the study group and will receive 500 µg of intra-silicon oil methotrexate at the end of the surgery and then at 1st, 2nd, 3rd , 4th and 6th post operative weeks.

Study Record Dates

• First Submitted: February 24, 2024
• First Posted: March 1, 2024
• Study Start: March 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: May 1, 2025
• Last Updated: March 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Starting six months after publishing, data will become available for one year.
• Access Criteria: Access will be granted for legitimate and scientifically sound research purposes that align with the objectives of the original study. Access will be contingent upon the ability of the requesting researchers to adhere to rigorous data security and privacy measures to safeguard participant confidentiality. Researchers should provide information on their intent to publish the results of their analysis, promoting transparency and accountability in the use of shared data. Requesting researchers must agree to and sign a Data Use Agreement (DUA) outlining the terms and conditions of data use, including restrictions, publication policies, and compliance with ethical standards.

Locations

PA (1)