To Compare Therapeutic Effect of Intravitreal Bevacizumab and Triamcinolone in Resistant Uveitic Cystoid Macular Edema

July 28, 2008 updated by: Shahid Beheshti University of Medical Sciences
Cystoid macular edema (CME) is one of the common causes of vision loss in patients with UveitiS .Triamcinolone has been effectively used in reducing CME and improving the vision. Also there are some documents which recommend Bevacizumab(avastin) could reduce macular edema. This study compare intravitreous injection of triamcinolone and avastin in patients with resistant uveitic cystoid macular edema.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This study compare intravitreous injection of triamcinolone and avastin in patients with resistant uveitic cystoid macular edema.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Uveitic CME
  • Uveitic CME refractory to routine treatment
  • Vision better than 5/200 and worse than 20/50

Exclusion Criteria:

  • Mono- Ocular patients
  • History of vitrectomy
  • Glaucoma or ocular hypertension
  • History of other retinal disease that can cause macular edema
  • Pregnancy
  • Significant media opacity
  • Vision better than 20/50

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
Intravitreal injection of Triamcinolone
Drug: Intravitreal injection of Triamcinolone
4 mg of Triamcinolone
ACTIVE_COMPARATOR: 2
Intravitreal injection of Avastin
Drug: Intravitreal injection of Avastin
Injection of 1.25 mg of Avastin and

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Resorbed CME in OCT
Time Frame: every 3 month
every 3 month
Resorbed CME in clinical examination
Time Frame: Every 3 month
Every 3 month

Secondary Outcome Measures

Outcome Measure
Time Frame
need to retreatment
Time Frame: when ever needed
when ever needed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shahid Beheshti University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (ACTUAL)

May 1, 2008

Study Completion (ANTICIPATED)

September 1, 2008

Study Registration Dates

First Submitted

August 31, 2006

First Submitted That Met QC Criteria

August 31, 2006

First Posted (ESTIMATE)

September 1, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

July 30, 2008

Last Update Submitted That Met QC Criteria

July 28, 2008

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8524

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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