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...
Date First Received: September 5, 2006
Last Updated: July 28, 2008
Verified by: Shaheed Beheshti Medical University, June 2008
Clinical Trial Phase: Phase 3 | Start Date: July 2005
Overall Status: Active, not recruiting
Brief Summary
Condition Keyword(s):
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 Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study
Study Primary Completion Date: August 2008
Intervention(s) in this Clinical Trial
- Drug: pyrimethamine-sulfadiazine + prednisolone
- Administration of pyrimethamine-sulfadiazine + prednisolone
- Drug: Clindamycin+Dexamethasone
- Intravitreal injection of Clindamycin+Dexamethasone
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: 1
- Classic regimen (Pyrimethamine-Sulfadiazine + Prednisolon)
- Active Comparator: 2
- Intravitreal Clindamycin & Dexamethasone
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: N/A
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Shaheed Beheshti Medical University
Overall Clinical Trial Officials and Contacts
Masoud Soheilian, MD Principal Investigator Ophthalmic Research Center of Shaheed Beheshti Medical University
Additional Information
Information obtained from ClinicalTrials.gov on November 19, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00372294
Study ID Number: 8415
ClinicalTrials.gov Identifier: NCT00372294
Health Authority: Iran: Ethics Committee
Clinical Trials Authorship and Review
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