Methotrexate in Retinal Detachment With Proliferative Vitreoretinopathy

NCT07058337 | Completed DMC

• 1 other identifier: Methorexate in PVR
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Retinal Detachment

Keywords

Proliferative Vitreoretinopathy; Rhegmatogenous Retinal Detachment; Methotrexate

Outcome Measures

Primary Outcomes (3)

• Visual Acuity

  Best-Corrected Visual Acuity (BCVA): BCVA will be measured using the logarithm of the minimum angle of resolution (LogMAR) scale. A LogMAR value of 0.0 corresponds to normal visual acuity (Snellen equivalent 6/6 or 20/20), representing the ability to resolve an optotype that subtends 5 minutes of arc. Visual acuity will be converted to LogMAR values for statistical analysis.

  3 and 6 months after tamponade removal

• Anatomical Success

  Successful Retinal Reattachment: Defined as complete reattachment of the neurosensory retina to the underlying retinal pigment epithelium (RPE) without persistent or recurrent subretinal fluid at the final follow-up visit, as confirmed by clinical examination and optical coherence tomography (OCT), in the absence of tamponade or additional surgical intervention.

  within 6 months after tamponade removal

• Number of Operations Required

  The total number of surgical procedures (including vitrectomy, scleral buckling, retinopexy, or tamponade exchange) required to achieve and maintain retinal reattachment will be recorded for each eye.

  within 6 months after tamponade removal

Study Arms (2)

Group 1 (PPV Alone)

ACTIVE COMPARATOR

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

Procedure: parsplana vitrectomy

Group 2 (PPV with Methotrexate)

ACTIVE COMPARATOR

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

Procedure: parsplana vitrectomy; Procedure: adjunctive use of Methotrexate

Interventions

parsplana vitrectomy PROCEDURE

23 gauge parsplana vitrectomy

Group 1 (PPV Alone); Group 2 (PPV with Methotrexate)

adjunctive use of Methotrexate PROCEDURE

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

Group 2 (PPV with Methotrexate)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Ebsar Eye Center

Cairo, Egypt, 4450113, Egypt

Location

MeSH Terms

Conditions

Retinal Detachment; Vitreoretinopathy, Proliferative

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: July 10, 2025
• Study Start: June 9, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 9, 2025
• Last Updated: July 10, 2025

Record last verified: 2025-07

Locations

EG (1)