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

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

This study is currently recruiting participants.
Verified by Shaheed Beheshti Medical University, June 2008

Sponsored by:	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

ChemIDplus related topics:

Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus Fluorouracil Heparin Colchicine

U.S. FDA Resources

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

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

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

Keywords provided by Shaheed Beheshti Medical University:

PVR

Oral colchicine

Dexamethasone

low molecular weight heparin

5-FU

Study placed in the following topic categories:

Dexamethasone

Body Weight

Heparin, Low-Molecular-Weight

Fluorouracil

Eye Diseases

Colchicine

Vitreoretinopathy, Proliferative

Heparin

Dexamethasone acetate

Retinal Diseases

Calcium heparin

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Physiological Effects of Drugs

Hematologic Agents

Hormones, Hormone Substitutes, and Hormone Antagonists

Antiemetics

Fibrinolytic Agents

Gout Suppressants

Hormones

Fibrin Modulating Agents

Therapeutic Uses

Anticoagulants

Antineoplastic Agents, Hormonal

Mitosis Modulators

Gastrointestinal Agents

Antimitotic Agents

Cardiovascular Agents

Glucocorticoids

Pharmacologic Actions

Autonomic Agents

Tubulin Modulators

Peripheral Nervous System Agents

Antirheumatic Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on September 04, 2008