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OpenTrials
Completed

NCT Number: NCT07058337

Methotrexate in Retinal Detachment With Proliferative Vitreoretinopathy

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

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Key information

Conditions

Retinal Detachment Eye Diseases Retinal Diseases Vitreoretinopathy, Proliferative

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ebsar Eye Center

Cairo, Egypt, 4450113

About this study

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:

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

parsplana vitrectomy

Procedure

23 gauge parsplana vitrectomy

adjunctive use of Methotrexate

Procedure

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

Primary outcomes

  1. Visual Acuity

    Time frame: 3 and 6 months after tamponade removal

    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.

  2. Anatomical Success

    Time frame: within 6 months after tamponade removal

    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.

  3. Number of Operations Required

    Time frame: within 6 months after tamponade removal

    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.

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

Methotrexate as an Adjunct to Parsplana Vitrectomy for the Preventing and Treatment of Proliferative Vitreoretinopathy in Rhegmatogenous Retinal Detachment: A Clinical Study

Acronym: Methotrexate

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 10, 2025
Registry last updated
Jul 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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