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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

Page last updated: August 20, 2015

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