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| 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 |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Hamid Ahmadieh, MD | +98 21 22585952 | hahmadieh@hotmail.com |
| Iran, Islamic Republic of | |
| Hamid Ahmadieh, MD | Recruiting |
| Tehran, Iran, Islamic Republic of, 16666 | |
| Contact: Hamid Ahmadieh, MD +98 21 22585952 hahmadieh@hotmail.com | |
| Principal Investigator: | Hamid Ahmadieh, MD | Ophthalmic Research Center of Shaheed Beheshti Medical University |
More Information
| Study ID Numbers: | 8404 |
| Study First Received: | August 30, 2006 |
| Last Updated: | June 25, 2008 |
| ClinicalTrials.gov Identifier: | NCT00370760 History of Changes |
| Health Authority: | Iran: Ethics Committee |
|
PVR Oral colchicine Dexamethasone low molecular weight heparin 5-FU |
|
Dexamethasone Anti-Inflammatory Agents Heparin, Low-Molecular-Weight Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Fibrinolytic Agents Hormones Calcium heparin Body Weight Fibrin Modulating Agents Colchicine Vitreoretinopathy, Proliferative |
Heparin Dexamethasone acetate Retinal Diseases Anticoagulants Antineoplastic Agents, Hormonal Eye Diseases Antimitotic Agents Cardiovascular Agents Glucocorticoids Fluorouracil Tubulin Modulators Peripheral Nervous System Agents Antirheumatic Agents |
|
Anti-Inflammatory Agents Dexamethasone Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Heparin, Low-Molecular-Weight Hematologic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Fibrinolytic Agents Gout Suppressants Hormones Fibrin Modulating Agents Therapeutic Uses Colchicine |
Vitreoretinopathy, Proliferative Heparin Dexamethasone acetate Retinal Diseases Anticoagulants Antineoplastic Agents, Hormonal Eye Diseases Mitosis Modulators Gastrointestinal Agents Cardiovascular Agents Antimitotic Agents Glucocorticoids Pharmacologic Actions Autonomic Agents Tubulin Modulators |
