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

Primary Purpose

Chorioretinitis

Status
Unknown status
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
pyrimethamine-sulfadiazine + prednisolone
Clindamycin+Dexamethasone
Sponsored by
Shahid Beheshti University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chorioretinitis focused on measuring Toxoplasmosis, Chorioretinitis, Intravitreal Clindamycin, Dexamethasone in chorioretinitis, Toxoplasmic

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ophthalmic Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Classic regimen (Pyrimethamine-Sulfadiazine + Prednisolon)

Intravitreal Clindamycin & Dexamethasone

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 5, 2006
Last Updated
July 28, 2008
Sponsor
Shahid Beheshti University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00372294
Brief Title
To Compare Intravitreal Clindamycin & Dexamethasone With Classic Treatment of Toxoplasmic Retinochoroiditis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Unknown status
Study Start Date
July 2005 (undefined)
Primary Completion Date
August 2008 (Anticipated)
Study Completion Date
November 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Shahid Beheshti University of Medical Sciences

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chorioretinitis
Keywords
Toxoplasmosis, Chorioretinitis, Intravitreal Clindamycin, Dexamethasone in chorioretinitis, Toxoplasmic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Classic regimen (Pyrimethamine-Sulfadiazine + Prednisolon)
Arm Title
2
Arm Type
Active Comparator
Arm Description
Intravitreal Clindamycin & Dexamethasone
Intervention Type
Drug
Intervention Name(s)
pyrimethamine-sulfadiazine + prednisolone
Intervention Description
Administration of pyrimethamine-sulfadiazine + prednisolone
Intervention Type
Drug
Intervention Name(s)
Clindamycin+Dexamethasone
Intervention Description
Intravitreal injection of Clindamycin+Dexamethasone

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masoud Soheilian, MD
Organizational Affiliation
Ophthalmic Research Center of Shaheed Beheshti Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ophthalmic Research Center
City
Tehran
ZIP/Postal Code
16666
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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