Repeated Methotrexate for Proliferative Vitreoretinopathy Grade C
NCT ID: NCT04482543
Last Updated: 2020-07-22
Study Results
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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UNKNOWN
PHASE2/PHASE3
74 participants
INTERVENTIONAL
2020-08-01
2021-09-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Intra-silicone oil injection of 250 µg methotrexate
Methotrexate
Intra-silicone oil injection of 250 µg methotrexate is done at the end of surgery and is repeated at weeks 3 and 6 postoperatively.
No intra-silicone oil injection of methotrexate
No interventions assigned to this group
Interventions
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Methotrexate
Intra-silicone oil injection of 250 µg methotrexate is done at the end of surgery and is repeated at weeks 3 and 6 postoperatively.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Pregnancy
* Glaucoma
* Macular disorders
* Diabetic retinopathy
* Retinal vascular occlusion
* History of penetrating ocular trauma
* Giant retinal tear
* Chronic uveitis
* History of intraocular steroid injection
18 Years
ALL
Yes
Sponsors
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Shahid Beheshti University of Medical Sciences
OTHER
Responsible Party
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Zahra Rabbani Khah
Head of ophthalmic research center
Locations
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Ophthalmic Research Center
Tehran, , Iran
Countries
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Central Contacts
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Facility Contacts
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References
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Nourinia R, Safi S, Mohammadpour M, Riazi-Esfahani H, Ansari Astaneh MR, Falavarjani KG, Ramezani A, Karimi S, Fekri S, Ebrahimiadib N, Khalili Pour E, Nikkhah H, Shoeibi N, Hassanpoor N, Hosseini M, Abrishami M, Abdi F, Rahimi A, Jabbarpoor Bonyadi MH, Moradian S, Khosravi Mirzaei S, Safi H, Anvari P, Fadakar K, Mirghorbani M, Mohammadbagheri N, Hatami F, Kheiri B, Yaseri M, Khorrami Z, Ahmadieh H. Effects of repeated intra-silicone oil injections of methotrexate on proliferative vitreoretinopathy grade C: a multicenter randomized controlled trial. Sci Rep. 2024 Nov 21;14(1):28842. doi: 10.1038/s41598-024-79708-1.
Other Identifiers
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23454
Identifier Type: -
Identifier Source: org_study_id
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