NCT00371020

Brief Summary

To evaluate the effect of combined 5-FU and low molecular weight heparin in infusion on the rate of retinal redetachment after silicone oil removal in cases of proliferative vitreoretinopathy (PVR).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2005

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 1, 2006

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

July 12, 2007

Status Verified

July 1, 2007

First QC Date

August 31, 2006

Last Update Submit

July 11, 2007

Conditions

Proliferative Vitreoretinopathy

Keywords

silicone oilPVRretinal redetachmentlow molecular weight heparin5-FU

Outcome Measures

Primary Outcomes (1)

  • Retinal redetachment rate

Secondary Outcomes (4)

  • visual acuity

  • intraocular pressure

  • reoperation

  • relative afferent pupillary defect

Interventions

low molecular weight heparin, 5-FUDRUG

Eligibility Criteria

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

You may qualify if:

  • Cases with history of vitrectomy and silicone oil injection for management of PVR who undergo silicone oil removal

You may not qualify if:

  • any sign of retinal redetachment before silicone oil removal
  • any sign of diabetic retinopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamid Ahmadieh, MD

Tehran, Tehran Province, 16666, Iran

Location

MeSH Terms

Conditions

Vitreoretinopathy, Proliferative

Interventions

Heparin, Low-Molecular-WeightFluorouracil

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

HeparinGlycosaminoglycansPolysaccharidesCarbohydratesUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Hamid Ahmadieh, MD

    Ophthalmic Research Center of Shaheed Beheshti Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 31, 2006

First Posted

September 1, 2006

Study Start

February 1, 2005

Study Completion

July 1, 2007

Last Updated

July 12, 2007

Record last verified: 2007-07

Locations

IR(1)