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

Tracking Information

First Received Date ^ICMJE

August 30, 2006

Last Updated Date

June 25, 2008

Start Date ^ICMJE

September 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Retinal reattachment rate

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00370760 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

PVR recurrence,
macular pucker,
reoperation,
ocular hypotony,
visual acuity

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Proliferative Vitreoretinopathy

Intervention ^ICMJE

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

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Hamid Ahmadieh, MD

+98 21 22585952

hahmadieh@hotmail.com

Location Countries ^ICMJE

Iran, Islamic Republic of

Administrative Information

NCT ID ^ICMJE

NCT00370760

Responsible Party

Study ID Numbers ^ICMJE

8404

Study Sponsor ^ICMJE

Shaheed Beheshti Medical University

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Hamid Ahmadieh, MD

Ophthalmic Research Center of Shaheed Beheshti Medical University

Information Provided By

Shaheed Beheshti Medical University

Verification Date

June 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP