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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Shahid Beheshti Medical University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Shahid Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT00372294
First received: September 5, 2006
Last updated: July 28, 2008
Last verified: June 2008
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Shahid Beheshti Medical University:

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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00372294

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

No publications provided

ClinicalTrials.gov Identifier: NCT00372294     History of Changes
Other Study ID Numbers: 8415
Study First Received: September 5, 2006
Last Updated: July 28, 2008
Health Authority: Iran: Ethics Committee

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

Additional relevant MeSH terms:
Chorioretinitis
Uveitis
Retinitis
Retinal Diseases
Eye Diseases
Choroiditis
Choroid Diseases
Uveal Diseases
Uveitis, Posterior
Panuveitis
Dexamethasone acetate
Methylprednisolone acetate
Prednisolone acetate
Dexamethasone
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Dexamethasone 21-phosphate
Prednisolone hemisuccinate
Prednisolone phosphate
BB 1101
Clindamycin
Clindamycin palmitate
Pyrimethamine
Clindamycin phosphate
Sulfadiazine
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics

ClinicalTrials.gov processed this record on October 01, 2014