Oral Colchicine Combined With Intravitreal Infusion of Dexamethasone, LMW Heparin and 5-FU for Management of Proliferative Vitreoretinopathy (PVR)

Phase 3

• Conditions: Proliferative Vitreoretinopathy
• Interventions: Drug: placebo; Drug: oral colchicine, dexamethasone, low molecular weight heparin, 5-FU

• Registration Number: NCT00370760
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief 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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-08-30
• Study First Submitted QC: 2006-08-30
• Study Start: 2006-09
• Study First Posted: 2006-09-01
• Status Verified: 2008-06
• Last Update Submitted: 2008-06-25
• Last Update Posted: 2008-06-26

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	placebo	-
1	oral colchicine, dexamethasone, low molecular weight heparin, 5-FU	-

Primary Outcome Measures

Name	Time	Method
Retinal reattachment rate

Secondary Outcome Measures

Name	Time	Method
PVR recurrence,
macular pucker,
reoperation,
ocular hypotony,
visual acuity

Trial Locations

Locations (1)

Hamid Ahmadieh, MD; 🇮🇷 Tehran, Iran, Islamic Republic of