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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2008 by Shahid Beheshti University of Medical Sciences.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00372294
First Posted: September 6, 2006
Last Update Posted: July 30, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Shahid Beheshti University of Medical Sciences
  Purpose
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.

Condition Intervention Phase
Chorioretinitis Drug: pyrimethamine-sulfadiazine + prednisolone Drug: Clindamycin+Dexamethasone Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Shahid Beheshti University of Medical Sciences:

Study Start Date: July 2005
Estimated Study Completion Date: November 2008
Estimated Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00372294


Locations
Iran, Islamic Republic of
Ophthalmic Research Center
Tehran, Iran, Islamic Republic of, 16666
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
Investigators
Principal Investigator: Masoud Soheilian, MD Ophthalmic Research Center of Shaheed Beheshti Medical University
  More Information

ClinicalTrials.gov Identifier: NCT00372294     History of Changes
Other Study ID Numbers: 8415
First Submitted: September 5, 2006
First Posted: September 6, 2006
Last Update Posted: July 30, 2008
Last Verified: June 2008

Keywords provided by Shahid Beheshti University of Medical Sciences:
Toxoplasmosis
Chorioretinitis
Intravitreal Clindamycin
Dexamethasone in chorioretinitis
Toxoplasmic

Additional relevant MeSH terms:
Chorioretinitis
Retinitis
Retinal Diseases
Eye Diseases
Choroiditis
Choroid Diseases
Uveal Diseases
Uveitis, Posterior
Panuveitis
Uveitis
Dexamethasone acetate
Prednisolone acetate
Methylprednisolone acetate
Dexamethasone
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
BB 1101
Clindamycin
Clindamycin palmitate
Pyrimethamine
Clindamycin phosphate
Sulfadiazine
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs