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To Compare Intravitreal Clindamycin & Dexamethasone With Classic Treatment of Toxoplasmic Retinochoroiditis

NCT ID: NCT00372294

Last Updated: 2008-07-30

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

2005-07-31

Study Completion Date

2008-11-30

Brief Summary

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Toxoplasmosis, an intra cellular parasite, is a very important cause of chorioretinitis. The goal of treatment is arresting multiplication of the parasite in its inflammatory active phase. In this study the investigators try to compare the efficacy of the classic regimen (Pyrimethamine-Sulfadiazine + Prednisolon) with intravitreal Clindamycin \& Dexamethasone.

Detailed Description

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Conditions

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Chorioretinitis

Keywords

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Toxoplasmosis Chorioretinitis Intravitreal Clindamycin Dexamethasone in chorioretinitis Toxoplasmic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Classic regimen (Pyrimethamine-Sulfadiazine + Prednisolon)

Group Type ACTIVE_COMPARATOR

pyrimethamine-sulfadiazine + prednisolone

Intervention Type DRUG

Administration of pyrimethamine-sulfadiazine + prednisolone

2

Intravitreal Clindamycin \& Dexamethasone

Group Type ACTIVE_COMPARATOR

Clindamycin+Dexamethasone

Intervention Type DRUG

Intravitreal injection of Clindamycin+Dexamethasone

Interventions

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pyrimethamine-sulfadiazine + prednisolone

Administration of pyrimethamine-sulfadiazine + prednisolone

Intervention Type DRUG

Clindamycin+Dexamethasone

Intravitreal injection of Clindamycin+Dexamethasone

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with Toxoplasmic chorioretinitis
* Location of the lesion within zone I of the retina or a lesion greater than 2DD with 3+-4+ vitreous inflammation in zone II or III
* No allergic history to the used drugs
* No any other diseases

Exclusion Criteria

* Any allergic reaction to the used medications
* One eyed patients
* Partially treated patients
Eligible Sex

ALL

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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Masoud Soheilian, MD

Role: PRINCIPAL_INVESTIGATOR

Ophthalmic Research Center of Shaheed Beheshti Medical University

Locations

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Ophthalmic Research Center

Tehran, Tehran Province, Iran

Site Status

Countries

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Iran

Other Identifiers

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8415

Identifier Type: -

Identifier Source: org_study_id