NCT00372294

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2005

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 5, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 6, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

July 30, 2008

Status Verified

June 1, 2008

Enrollment Period

3.1 years

First QC Date

September 5, 2006

Last Update Submit

July 28, 2008

Conditions

Chorioretinitis

Keywords

ToxoplasmosisChorioretinitisIntravitreal ClindamycinDexamethasone in chorioretinitisToxoplasmic

Study Arms (2)

1

ACTIVE COMPARATOR

Classic regimen (Pyrimethamine-Sulfadiazine + Prednisolon)

Drug: pyrimethamine-sulfadiazine + prednisolone

2

ACTIVE COMPARATOR

Intravitreal Clindamycin \& Dexamethasone

Drug: Clindamycin+Dexamethasone

Interventions

pyrimethamine-sulfadiazine + prednisoloneDRUG

Administration of pyrimethamine-sulfadiazine + prednisolone

1
Clindamycin+DexamethasoneDRUG

Intravitreal injection of Clindamycin+Dexamethasone

2

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Any allergic reaction to the used medications
  • One eyed patients
  • Partially treated patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ophthalmic Research Center

Tehran, Tehran Province, 16666, Iran

Location

MeSH Terms

Conditions

ChorioretinitisToxoplasmosis

Interventions

Prednisolone

Condition Hierarchy (Ancestors)

RetinitisRetinal DiseasesEye DiseasesChoroiditisChoroid DiseasesUveal DiseasesUveitis, PosteriorPanuveitisUveitisCoccidiosisProtozoan InfectionsParasitic DiseasesInfections

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Masoud Soheilian, MD

    Ophthalmic Research Center of Shaheed Beheshti Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 5, 2006

First Posted

September 6, 2006

Study Start

July 1, 2005

Primary Completion

August 1, 2008

Study Completion

November 1, 2008

Last Updated

July 30, 2008

Record last verified: 2008-06

Locations

IR(1)