NCT00370201

Brief Summary

This clinical trial will test the efficacy and safety of oral colchicine in prevention of proliferative vitreoretinopathy (PVR) in cases of rhegmatogenous retinal detachment

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 Mar 2004

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

March 1, 2004

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

August 30, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 31, 2006

Completed
Last Updated

October 9, 2006

Status Verified

March 1, 2004

First QC Date

August 30, 2006

Last Update Submit

October 6, 2006

Conditions

Rhegmatogenous Retinal Detachment

Keywords

retinal detachmentproliferative vitreoretinopathy

Outcome Measures

Primary Outcomes (2)

  • proliferative vitreoretinopathy

  • retinal reattachment rate

Secondary Outcomes (3)

  • visual acuity

  • reoperation

  • macular pucker

Interventions

colchicineDRUG

Eligibility Criteria

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

You may qualify if:

  • Rhegmatogenous retinal detachment

You may not qualify if:

  • PVR grade C
  • Duration of retinal detachment ≥ one month
  • History of cataract surgery
  • History of RD surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamid Ahmadieh,MD

Tehran, Tehran Province, 16666, Iran

Location

MeSH Terms

Conditions

Retinal DetachmentVitreoretinopathy, Proliferative

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

AlkaloidsHeterocyclic 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 30, 2006

First Posted

August 31, 2006

Study Start

March 1, 2004

Study Completion

August 1, 2006

Last Updated

October 9, 2006

Record last verified: 2004-03

Locations

IR(1)