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

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ClinicalTrials.gov Identifier: NCT00372294
Recruitment Status : Unknown
Verified June 2008 by Shahid Beheshti University of Medical Sciences.
Recruitment status was:  Active, not recruiting
First Posted : September 6, 2006
Last Update Posted : July 30, 2008
Sponsor:
Information provided by:
Shahid Beheshti University of Medical Sciences

Brief Summary:
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 or disease Intervention/treatment Phase
Chorioretinitis Drug: pyrimethamine-sulfadiazine + prednisolone Drug: Clindamycin+Dexamethasone Phase 3

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : July 2005
Estimated Primary Completion Date : August 2008
Estimated Study Completion Date : November 2008


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





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Ages Eligible for Study:   Child, Adult, Older Adult
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

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

ClinicalTrials.gov Identifier: NCT00372294     History of Changes
Other Study ID Numbers: 8415
First Posted: September 6, 2006    Key Record Dates
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