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Repeated Methotrexate for Proliferative Vitreoretinopathy Grade C

Primary Purpose

Proliferative Vitreoretinopathy

Status
Unknown status
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Methotrexate
Sponsored by
Shahid Beheshti University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Proliferative Vitreoretinopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Rhegmatogenous retinal detachment with proliferative vitreoretinopathy grade C

Exclusion Criteria:

  • Age of under 18 years old
  • Pregnancy
  • Glaucoma
  • Macular disorders
  • Diabetic retinopathy
  • Retinal vascular occlusion
  • History of penetrating ocular trauma
  • Giant retinal tear
  • Chronic uveitis
  • History of intraocular steroid injection

Sites / Locations

  • Ophthalmic Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Intra-silicone oil injection of 250 µg methotrexate

No intra-silicone oil injection of methotrexate

Arm Description

Outcomes

Primary Outcome Measures

Retinal reattachment rate
Funduscopy

Secondary Outcome Measures

Best corrected visual acuity
Snellen chart
Retinal reproliferation rate
Funduscopy
Adverse events
Slit-lamp, tonometry and funduscopy

Full Information

First Posted
July 18, 2020
Last Updated
July 18, 2020
Sponsor
Shahid Beheshti University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04482543
Brief Title
Repeated Methotrexate for Proliferative Vitreoretinopathy Grade C
Official Title
Repeated Intra-silicone Oil Injection of Methotrexate for Management of Proliferative Vitreoretinopathy Grade C; A Multi-center Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2020 (Anticipated)
Primary Completion Date
July 1, 2021 (Anticipated)
Study Completion Date
September 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Beheshti University of Medical Sciences

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
This multicenter randomized clinical trial evaluates the effect of multiple intra-silicone oil injections of methotrexate (MTX) on rhegmatogenous retinal detachment (RRD) with grade C proliferative vitreoretinopathy (PVR). 74 eyes with the diagnosis of RRD with PVR grade C will be randomized into two groups: the intervention group and the control group. All eyes undergo pars plana vitrectomy(PPV) and intraocular injection of silicone oil (SO). At the end of the surgical procedure, intra-SO injection of 250 µg MTX will be performed in the intervention group. No intra-SO injection will be done in the control group. In the intervention group, Intra-SO injection of MTX will be repeated at 3 and 6 weeks postoperatively. Silicone oil removal will be done 3 months after surgery.Spectral-domain optical coherence tomography (SD-OCT) image of the macula will be acquired at months 3 and 6. The retinal reattachment rate at months 6 will be assessed as the main outcome measure of the study. Best corrected visual acuity, retinal reproliferation rate and adverse events are the secondary outcome measures. Comprehensive ocular examination will be performed at weeks 1, 3, 6 and at months 3, 4 and 6.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proliferative Vitreoretinopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
74 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intra-silicone oil injection of 250 µg methotrexate
Arm Type
Active Comparator
Arm Title
No intra-silicone oil injection of methotrexate
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Description
Intra-silicone oil injection of 250 µg methotrexate is done at the end of surgery and is repeated at weeks 3 and 6 postoperatively.
Primary Outcome Measure Information:
Title
Retinal reattachment rate
Description
Funduscopy
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Best corrected visual acuity
Description
Snellen chart
Time Frame
6 months
Title
Retinal reproliferation rate
Description
Funduscopy
Time Frame
6 months
Title
Adverse events
Description
Slit-lamp, tonometry and funduscopy
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Rhegmatogenous retinal detachment with proliferative vitreoretinopathy grade C Exclusion Criteria: Age of under 18 years old Pregnancy Glaucoma Macular disorders Diabetic retinopathy Retinal vascular occlusion History of penetrating ocular trauma Giant retinal tear Chronic uveitis History of intraocular steroid injection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hamid Ahmadieh, MD
Phone
+98 9122195871
Email
hahmadieh@hotmail.com
Facility Information:
Facility Name
Ophthalmic Research Center
City
Tehran
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hamid Ahmadieh, MD
Phone
+98 9122195871
Email
hahmadieh@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

Repeated Methotrexate for Proliferative Vitreoretinopathy Grade C

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