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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00371111
Other study ID # 8524
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received August 31, 2006
Last updated July 28, 2008
Start date August 2006
Est. completion date September 2008

Study information

Verified date July 2008
Source hahid Beheshti University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority Iran: Ethics Committee
Study type Interventional

Clinical Trial 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.


Description:

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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 40
Est. completion date September 2008
Est. primary completion date May 2008
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Intravitreal injection of Triamcinolone
4 mg of Triamcinolone
Intravitreal injection of Avastin
Injection of 1.25 mg of Avastin and

Locations

Country Name City State
Iran, Islamic Republic of Masoud Soheilian , MD Tehran

Sponsors (1)

Lead Sponsor Collaborator
hahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Resorbed CME in OCT every 3 month No
Primary Resorbed CME in clinical examination Every 3 month No
Secondary need to retreatment when ever needed No