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

• Sponsor: Shahid Beheshti University of Medical Sciences (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00372294
• Collaborator: (none)
• Location: 1
• Arms: 2
• Duration (Months): 40

Study Details

Study Description

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 Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Study Start Date: Jul 1, 2005
• Anticipated Primary Completion Date: Aug 1, 2008
• Anticipated Study Completion Date: Nov 1, 2008

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00372294
• Other Study ID Numbers: 8415
• First Posted: Sep 6, 2006
• Last Update Posted: Jul 30, 2008
• Last Verified: Jun 1, 2008

• Keywords provided by , ,: Toxoplasmosis; Chorioretinitis; Intravitreal Clindamycin; Dexamethasone in chorioretinitis; Toxoplasmic
• Additional relevant MeSH terms: Chorioretinitis; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Sulfadiazine; Pyrimethamine; Dexamethasone; Prednisolone

Study Results

No Results Posted as of Jul 30, 2008