Methotrexate in Retinal Detachment With Proliferative Vitreoretinopathy

NCT ID: NCT07058337

Last Updated: 2025-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-09

Study Completion Date

2025-06-09

Brief Summary

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The aim of this study is to evaluate the efficacy and safety of intraocular methotrexate (MTX) in preventing and managing proliferative vitreoretinopathy (PVR) in patients undergoing retinal detachment surgery

Detailed Description

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Patients will be randomized into two groups if clinical evidence of PVR is detected at the time of surgery, utilizing a computer-generated list for randomization. All surgeries will be conducted by the same surgeon to maintain consistency in technique.

Intervention Groups:

1\. Group 1 (PPV Alone): Patients in this group will undergo pars plana vitrectomy (PPV) only.

Group 2 (PPV with Methotrexate): Patients in this group will receive complete PPV along with adjunctive intravitreal methotrexate.

Conditions

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Retinal Detachment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1 (PPV Alone)

Patients in this group will undergo pars plana vitrectomy (PPV) only.

Group Type ACTIVE_COMPARATOR

parsplana vitrectomy

Intervention Type PROCEDURE

23 gauge parsplana vitrectomy

Group 2 (PPV with Methotrexate)

Patients in this group will receive complete PPV along with adjunctive intravitreal methotrexate

Group Type ACTIVE_COMPARATOR

parsplana vitrectomy

Intervention Type PROCEDURE

23 gauge parsplana vitrectomy

adjunctive use of Methotrexate

Intervention Type PROCEDURE

intravitreal methotrexate (200 μg/0.05 ml) at the time of surgery and repeated weekly for four weeks postoperatively

Interventions

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parsplana vitrectomy

23 gauge parsplana vitrectomy

Intervention Type PROCEDURE

adjunctive use of Methotrexate

intravitreal methotrexate (200 μg/0.05 ml) at the time of surgery and repeated weekly for four weeks postoperatively

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients aged 18 years and older.
* Diagnosed with RRD with clinical signs of PVR.
* No history of prior ocular surgeries for RRD or PVR.

Exclusion Criteria

* Patients with other retinal diseases (e.g., diabetic retinopathy or retinal vascular occlusions).
* Individuals with significant systemic illnesses that could influence surgical outcomes.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Benha University

OTHER

Sponsor Role lead

Responsible Party

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Ehab Mohamed Elsayed Mohamed Saad

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ebsar Eye Center

Cairo, Egypt, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Methorexate in PVR

Identifier Type: -

Identifier Source: org_study_id

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