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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified June 2008 by Shaheed Beheshti Medical University. Recruitment status was Recruiting

First Received on August 30, 2006. Last Updated on June 25, 2008 History of Changes

Sponsor:	Shaheed Beheshti Medical University
Information provided by:	Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier:	NCT00370760

Purpose

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)

Condition	Intervention	Phase
Proliferative Vitreoretinopathy	Drug: oral colchicine, dexamethasone, low molecular weight heparin, 5-FU Drug: placebo	Phase III

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

Resource links provided by NLM:

MedlinePlus related topics: Blood Thinners

Drug Information available for: Dexamethasone Fluorouracil Colchicine Dexamethasone acetate Doxiproct plus Dexamethasone Sodium Phosphate Heparin

U.S. FDA Resources

Further study details as provided by Shaheed Beheshti Medical University:

Primary Outcome Measures:

Retinal reattachment rate

Secondary Outcome Measures:

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

Study Start Date:

September 2006

Arms	Assigned Interventions
Active Comparator: 1	Drug: oral colchicine, dexamethasone, low molecular weight heparin, 5-FU
Placebo Comparator: 2	Drug: placebo

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00370760

Contacts

Contact: Hamid Ahmadieh, MD

+98 21 22585952

hahmadieh@hotmail.com

Locations

Iran, Islamic Republic of
Hamid Ahmadieh, MD	Recruiting
Tehran, Iran, Islamic Republic of, 16666
Contact: Hamid Ahmadieh, MD +98 21 22585952 hahmadieh@hotmail.com

Sponsors and Collaborators

Shaheed Beheshti Medical University

Investigators

Principal Investigator:

Hamid Ahmadieh, MD

Ophthalmic Research Center of Shaheed Beheshti Medical University

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00370760 History of Changes
Other Study ID Numbers:	8404
Study First Received:	August 30, 2006
Last Updated:	June 25, 2008
Health Authority:	Iran: Ethics Committee

Keywords provided by Shaheed Beheshti Medical University:

PVR
Oral colchicine
Dexamethasone
low molecular weight heparin
5-FU

Additional relevant MeSH terms:

Vitreoretinopathy, Proliferative
Retinal Diseases
Eye Diseases
Colchicine
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Fluorouracil
BB 1101
Calcium heparin
Heparin
Heparin, Low-Molecular-Weight
Dalteparin
Tubulin Modulators
Antimitotic Agents

Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Gout Suppressants
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids

ClinicalTrials.gov processed this record on February 13, 2012