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

Proliferative Vitreoretinopathy Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00370760
• Other study ID #: 8404
• Status: Recruiting
• Phase: Phase 3
• First received: August 30, 2006
• Last updated: June 25, 2008
• Start date: September 2006

Study information

• Verified date: June 2008
• Source: hahid Beheshti University of Medical Sciences
• Contact: Hamid Ahmadieh, MD
• Phone: +98 21 22585952
• Email: hahmadieh[@]hotmail.com
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Proliferative Vitreoretinopathy

Intervention

Drug:
• oral colchicine, dexamethasone, low molecular weight heparin, 5-FU

• placebo

Locations

Country	Name	City	State
Iran, Islamic Republic of	Hamid Ahmadieh, MD	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
hahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retinal reattachment rate
Secondary	PVR recurrence,
Secondary	macular pucker,
Secondary	reoperation,
Secondary	ocular hypotony,
Secondary	visual acuity