Back to resultsOral Colchicine Combined With Intravitreal Infusion of Dexamethasone, LMW Heparin and 5-FU for Management of Proliferative Vitreoretinopathy (PVR)
Primary Purpose
Proliferative Vitreoretinopathy
Status
Unknown status
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
oral colchicine, dexamethasone, low molecular weight heparin, 5-FU
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Proliferative Vitreoretinopathy focused on measuring PVR, Oral colchicine, Dexamethasone, low molecular weight heparin, 5-FU
Eligibility 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
Sites / Locations
- Hamid Ahmadieh, MDRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Retinal reattachment rate
Secondary Outcome Measures
PVR recurrence,
macular pucker,
reoperation,
ocular hypotony,
visual acuity
Full Information
NCT ID
NCT00370760
First Posted
August 30, 2006
Last Updated
June 25, 2008
Sponsor
Shahid Beheshti University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT00370760
Brief Title
Oral Colchicine Combined With Intravitreal Infusion of Dexamethasone, LMW Heparin and 5-FU for Management of Proliferative Vitreoretinopathy (PVR)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Unknown status
Study Start Date
September 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Shahid Beheshti University of Medical Sciences
4. Oversight
5. Study Description
Brief Summary
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proliferative Vitreoretinopathy
Keywords
PVR, Oral colchicine, Dexamethasone, low molecular weight heparin, 5-FU
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
oral colchicine, dexamethasone, low molecular weight heparin, 5-FU
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Retinal reattachment rate
Secondary Outcome Measure Information:
Title
PVR recurrence,
Title
macular pucker,
Title
reoperation,
Title
ocular hypotony,
Title
visual acuity
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hamid Ahmadieh, MD
Phone
+98 21 22585952
Email
hahmadieh@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hamid Ahmadieh, MD
Organizational Affiliation
Ophthalmic Research Center of Shaheed Beheshti Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamid Ahmadieh, MD
City
Tehran
ZIP/Postal Code
16666
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hamid Ahmadieh, MD
Phone
+98 21 22585952
Email
hahmadieh@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
Oral Colchicine Combined With Intravitreal Infusion of Dexamethasone, LMW Heparin and 5-FU for Management of Proliferative Vitreoretinopathy (PVR)
We'll reach out to this number within 24 hrs