Oral Colchicine Combined With Intravitreal Infusion of Dexamethasone, LMW Heparin and 5-FU for Management of Proliferative Vitreoretinopathy (PVR)
Information source: Shahid Beheshti Medical University
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Proliferative Vitreoretinopathy
Intervention: oral colchicine, dexamethasone, low molecular weight heparin, 5-FU (Drug); placebo (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Shahid Beheshti Medical University Official(s) and/or principal investigator(s): Hamid Ahmadieh, MD, Principal Investigator, Affiliation: Ophthalmic Research Center of Shaheed Beheshti Medical University
Overall contact: Hamid Ahmadieh, MD, Phone: +98 21 22585952, Email: hahmadieh@hotmail.com
Summary
To evaluate the efficacy of oral colchicine combined with intraoperative infusion of
dexamethasone, low molecular weight heparin and 5-FU during vitrectomy for management of
established proliferative vitreoretinopathy (PVR)
Clinical Details
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Retinal reattachment rate
Secondary outcome: PVR recurrence,macular pucker, reoperation, ocular hypotony, visual acuity
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Cases with rhegmatogenous retinal detachment complicated by PVR grade C
Exclusion Criteria:
- History of pars plana vitrectomy for PVR grade C
- History of silicone oil injection
- History of ocular trauma
- Diabetic retinopathy
- Glaucoma
- Giant retinal tear
Locations and Contacts
Hamid Ahmadieh, MD, Phone: +98 21 22585952, Email: hahmadieh@hotmail.com
Hamid Ahmadieh, MD, Tehran 16666, Iran, Islamic Republic of; Recruiting Hamid Ahmadieh, MD, Phone: +98 21 22585952, Email: hahmadieh@hotmail.com
Additional Information
Starting date: September 2006
Last updated: June 25, 2008
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