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

July 28, 2008 updated by: Shahid Beheshti University of Medical Sciences
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
Classic regimen (Pyrimethamine-Sulfadiazine + Prednisolon)
Drug: pyrimethamine-sulfadiazine + prednisolone
Administration of pyrimethamine-sulfadiazine + prednisolone
ACTIVE_COMPARATOR: 2
Intravitreal Clindamycin & Dexamethasone
Drug: Clindamycin+Dexamethasone
Intravitreal injection of Clindamycin+Dexamethasone

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shahid Beheshti University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (ANTICIPATED)

August 1, 2008

Study Completion (ANTICIPATED)

November 1, 2008

Study Registration Dates

First Submitted

September 5, 2006

First Submitted That Met QC Criteria

September 5, 2006

First Posted (ESTIMATE)

September 6, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

July 30, 2008

Last Update Submitted That Met QC Criteria

July 28, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8415

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Locations

3
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