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

Primary Purpose

Resistant Cystoid Macular Edema

Status
Unknown status
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Intravitreal injection of Triamcinolone
Intravitreal injection of Avastin
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 Resistant Cystoid Macular Edema focused on measuring Resistant uveitic cystoid macular edema, intravitreal triamcinolone, intravitreal bevacizumab

Eligibility Criteria

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

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

Sites / Locations

  • Masoud Soheilian , MD

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Intravitreal injection of Triamcinolone

Intravitreal injection of Avastin

Outcomes

Primary Outcome Measures

Resorbed CME in OCT
Resorbed CME in clinical examination

Secondary Outcome Measures

need to retreatment

Full Information

First Posted
August 31, 2006
Last Updated
July 28, 2008
Sponsor
Shahid Beheshti University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00371111
Brief Title
To Compare Therapeutic Effect of Intravitreal Bevacizumab and Triamcinolone in Resistant Uveitic Cystoid Macular Edema
Study Type
Interventional

2. Study Status

Record Verification Date
July 2008
Overall Recruitment Status
Unknown status
Study Start Date
August 2006 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
September 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Shahid Beheshti University of Medical Sciences

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Resistant Cystoid Macular Edema
Keywords
Resistant uveitic cystoid macular edema, intravitreal triamcinolone, intravitreal bevacizumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Intravitreal injection of Triamcinolone
Arm Title
2
Arm Type
Active Comparator
Arm Description
Intravitreal injection of Avastin
Intervention Type
Drug
Intervention Name(s)
Intravitreal injection of Triamcinolone
Intervention Description
4 mg of Triamcinolone
Intervention Type
Drug
Intervention Name(s)
Intravitreal injection of Avastin
Intervention Description
Injection of 1.25 mg of Avastin and
Primary Outcome Measure Information:
Title
Resorbed CME in OCT
Time Frame
every 3 month
Title
Resorbed CME in clinical examination
Time Frame
Every 3 month
Secondary Outcome Measure Information:
Title
need to retreatment
Time Frame
when ever needed

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
Masoud Soheilian , MD
City
Tehran
ZIP/Postal Code
16666
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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