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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. The completion date has passed and the status has not been verified in more than two years.
Verified June 2008 by Shahid Beheshti University of Medical Sciences.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00370760
First Posted: September 1, 2006
Last Update Posted: June 26, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Shahid Beheshti University of Medical Sciences
August 30, 2006
September 1, 2006
June 26, 2008
September 2006
Not Provided
Retinal reattachment rate
Same as current
Complete list of historical versions of study NCT00370760 on ClinicalTrials.gov Archive Site
  • PVR recurrence,
  • macular pucker,
  • reoperation,
  • ocular hypotony,
  • visual acuity
Same as current
Not Provided
Not Provided
 
Oral Colchicine Combined With Intravitreal Infusion of Dexamethasone, LMW Heparin and 5-FU for Management of Proliferative Vitreoretinopathy (PVR)
Not Provided
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)
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Proliferative Vitreoretinopathy
  • Drug: oral colchicine, dexamethasone, low molecular weight heparin, 5-FU
  • Drug: placebo
  • Active Comparator: 1
    Intervention: Drug: oral colchicine, dexamethasone, low molecular weight heparin, 5-FU
  • Placebo Comparator: 2
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
Not Provided
Not Provided
Not Provided

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
Sexes Eligible for Study: Male
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
 
NCT00370760
8404
Not Provided
Not Provided
Not Provided
Not Provided
Shahid Beheshti University of Medical Sciences
Not Provided
Principal Investigator: Hamid Ahmadieh, MD Ophthalmic Research Center of Shaheed Beheshti Medical University
Shahid Beheshti University of Medical Sciences
June 2008

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