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Oral Colchicine Combined With Intravitreal Infusion of Dexamethasone, LMW Heparin and 5-FU for Management of Proliferative Vitreoretinopathy (PVR)

NCT ID: NCT00370760

Last Updated: 2008-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Brief Summary

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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)

Detailed Description

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Conditions

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Proliferative Vitreoretinopathy

Keywords

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PVR Oral colchicine Dexamethasone low molecular weight heparin 5-FU

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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1

Group Type ACTIVE_COMPARATOR

oral colchicine, dexamethasone, low molecular weight heparin, 5-FU

Intervention Type DRUG

2

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Interventions

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oral colchicine, dexamethasone, low molecular weight heparin, 5-FU

Intervention Type DRUG

placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role lead

Principal Investigators

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Hamid Ahmadieh, MD

Role: PRINCIPAL_INVESTIGATOR

Ophthalmic Research Center of Shaheed Beheshti Medical University

Locations

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Hamid Ahmadieh, MD

Tehran, Tehran Province, Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Hamid Ahmadieh, MD

Role: CONTACT

Phone: +98 21 22585952

Email: [email protected]

Facility Contacts

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Hamid Ahmadieh, MD

Role: primary

Other Identifiers

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8404

Identifier Type: -

Identifier Source: org_study_id