To Compare Intravitreal Clindamycin & Dexamethasone With... | NCT00372294

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

NCT00372294

Sponsor

Shahid Beheshti University of Medical Sciences

Status

Unknown status

Last Update Posted

Jul 30, 2008Estimated

Enrollment

Not provided

Phase

Phase 3

Conditions

Chorioretinitis

Interventions

pyrimethamine-sulfadiazine + prednisolone
Clindamycin+Dexamethasone

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2005

Primary Completion Date

Aug 2008Estimated

Completion Date

Nov 2008Estimated

First Submitted Date

Sep 5, 2006

First Submission Date that Met QC Criteria

Sep 5, 2006

First Posted Date

Sep 6, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 28, 2008

Last Update Posted Date

Jul 30, 2008Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Classic regimen (Pyrimethamine-Sulfadiazine + Prednisolon)	Drug: pyrimethamine-sulfadiazine + prednisolone
2	Active Comparator	Intravitreal Clindamycin & Dexamethasone	Drug: Clindamycin+Dexamethasone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
pyrimethamine-sulfadiazine + prednisolone	Drug	Administration of pyrimethamine-sulfadiazine + prednisolone	1

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Masoud Soheilian, MD	Ophthalmic Research Center of Shaheed Beheshti Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ophthalmic Research Center		Tehran	Tehran Province	16666	Iran

Condition Browse Module

MeSH Terms

ID	Term
D002825	Chorioretinitis
D014123	Toxoplasmosis

Ancestor Terms

ID	Term
D012173	Retinitis
D012164	Retinal Diseases
D005128	Eye Diseases
D002833	Choroiditis

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011239	Prednisolone

Ancestor Terms

ID	Term
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids

Browse Leaves

Not provided

Browse Branches

Not provided