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

August 30, 2006
June 25, 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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.
 
Recruiting
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
Male
18 Years to 65 Years
No
Contact: Hamid Ahmadieh, MD +98 21 22585952 hahmadieh@hotmail.com
Iran, Islamic Republic of
 
NCT00370760
8404
Not Provided
Not Provided
Shahid Beheshti Medical University
Not Provided
Principal Investigator: Hamid Ahmadieh, MD Ophthalmic Research Center of Shaheed Beheshti Medical University
Shahid Beheshti Medical University
June 2008

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