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 Shahid Beheshti Medical University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Shahid Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT00370760
First received: August 30, 2006
Last updated: June 25, 2008
Last verified: June 2008
  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 3

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:


Further study details as provided by Shahid 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
Shahid 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 Shahid 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 April 16, 2014