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

This study is ongoing, but not recruiting participants.

First Received: September 5, 2006 Last Updated: July 28, 2008 History of Changes

Sponsor:	Shaheed Beheshti Medical University
Information provided by:	Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier:	NCT00372294

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study

Resource links provided by NLM:

MedlinePlus related topics: Toxoplasmosis

Drug Information available for: Dexamethasone Prednisolone Prednisolone acetate Depo-medrol Pyrimethamine Sulfadiazine Clindamycin Clindamycin hydrochloride Clindamycin phosphate Clindamycin Palmitate Hydrochloride Clindamycin palmitate Dexamethasone acetate Doxiproct plus Medrol veriderm Methylprednisolone Prednisolone sodium phosphate Prednisolone Sodium Succinate Dexamethasone Sodium Phosphate Methylprednisolone Sodium Succinate Methylprednisolone hemisuccinate 6-Methylprednisolone

U.S. FDA Resources

Further study details as provided by Shaheed 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
1: Active Comparator Classic regimen (Pyrimethamine-Sulfadiazine + Prednisolon)	Drug: pyrimethamine-sulfadiazine + prednisolone Administration of pyrimethamine-sulfadiazine + prednisolone
2: Active Comparator 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

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

Shaheed Beheshti Medical University

Investigators

Principal Investigator:

Masoud Soheilian, MD

Ophthalmic Research Center of Shaheed Beheshti Medical University

More Information

No publications provided

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

Keywords provided by Shaheed Beheshti Medical University:

Toxoplasmosis
Chorioretinitis
Intravitreal Clindamycin
Dexamethasone in chorioretinitis
Toxoplasmic

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Pyrimethamine
Panuveitis
Dexamethasone
Anti-Infective Agents
Antiprotozoal Agents
Clindamycin
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Uveitis, Posterior
Methylprednisolone
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Retinitis
Antiemetics

Prednisolone acetate
Neuroprotective Agents
Hormones
Antimalarials
Anti-Bacterial Agents
Antiparasitic Agents
Uveitis
Therapeutic Uses
Coccidiostats
Retinal Diseases
Dexamethasone acetate
Methylprednisolone Hemisuccinate
Uveal Diseases
Antineoplastic Agents, Hormonal
Clindamycin-2-phosphate

ClinicalTrials.gov processed this record on February 08, 2010