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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

Tracking Information
First Submitted Date  ICMJE September 5, 2006
First Posted Date  ICMJE September 6, 2006
Last Update Posted Date July 30, 2008
Study Start Date  ICMJE July 2005
Estimated Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00372294 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE To Compare Intravitreal Clindamycin & Dexamethasone With Classic Treatment of Toxoplasmic Retinochoroiditis
Official Title  ICMJE Not Provided
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Chorioretinitis
Intervention  ICMJE
  • Drug: pyrimethamine-sulfadiazine + prednisolone
    Administration of pyrimethamine-sulfadiazine + prednisolone
  • Drug: Clindamycin+Dexamethasone
    Intravitreal injection of Clindamycin+Dexamethasone
Study Arms  ICMJE
  • Active Comparator: 1
    Classic regimen (Pyrimethamine-Sulfadiazine + Prednisolon)
    Intervention: Drug: pyrimethamine-sulfadiazine + prednisolone
  • Active Comparator: 2
    Intravitreal Clindamycin & Dexamethasone
    Intervention: Drug: Clindamycin+Dexamethasone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE November 2008
Estimated Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00372294
Other Study ID Numbers  ICMJE 8415
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Shahid Beheshti University of Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Masoud Soheilian, MD Ophthalmic Research Center of Shaheed Beheshti Medical University
PRS Account Shahid Beheshti University of Medical Sciences
Verification Date June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP