NCT00370760

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)

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2006

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
Last Updated

June 26, 2008

Status Verified

June 1, 2008

First QC Date

August 30, 2006

Last Update Submit

June 25, 2008

Conditions

Proliferative Vitreoretinopathy

Keywords

PVROral colchicineDexamethasonelow molecular weight heparin5-FU

Outcome Measures

Primary Outcomes (1)

  • Retinal reattachment rate

Secondary Outcomes (5)

  • PVR recurrence,

  • macular pucker,

  • reoperation,

  • ocular hypotony,

  • visual acuity

Study Arms (2)

1

ACTIVE COMPARATOR
Drug: oral colchicine, dexamethasone, low molecular weight heparin, 5-FU

2

PLACEBO COMPARATOR
Drug: placebo

Interventions

oral colchicine, dexamethasone, low molecular weight heparin, 5-FUDRUG
1
placeboDRUG
2

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cases with rhegmatogenous retinal detachment complicated by PVR grade C

You may not qualify if:

  • History of pars plana vitrectomy for PVR grade C
  • History of silicone oil injection
  • History of ocular trauma
  • Diabetic retinopathy
  • Glaucoma
  • Giant retinal tear

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamid Ahmadieh, MD

Tehran, Tehran Province, 16666, Iran

RECRUITING

MeSH Terms

Conditions

Vitreoretinopathy, Proliferative

Interventions

ColchicineDexamethasoneHeparin, Low-Molecular-WeightFluorouracil

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

AlkaloidsHeterocyclic CompoundsPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedHeparinGlycosaminoglycansPolysaccharidesCarbohydratesUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Hamid Ahmadieh, MD

    Ophthalmic Research Center of Shaheed Beheshti Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hamid Ahmadieh, MD

CONTACT

+98 21 22585952hahmadieh@hotmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 30, 2006

First Posted

September 1, 2006

Study Start

September 1, 2006

Last Updated

June 26, 2008

Record last verified: 2008-06

Locations

IR(1)