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
About this trial
This is an interventional treatment trial for Proliferative Vitreoretinopathy
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
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
NCT ID
NCT04482543
First Posted
July 18, 2020
Last Updated
July 18, 2020
Sponsor
Shahid Beheshti University of Medical Sciences
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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