The Comparison Between the Therapeutic Affect of Intravitreal Diclophenac and Triamcinolone in Persistent Uveitic Cystoids Macular Edema

Uveitis Clinical Trial

Official title:

The Comparison Between the Therapeutic Affect of Intravitreal Diclophenac and Triamcinolone in Persistent Uveitic Cystoids Macular Edema

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00893854
• Other study ID #: 8727
• Status: Recruiting
• Phase: Phase 1
• First received: May 4, 2009
• Last updated: May 4, 2009

Study information

• Verified date: May 2009
• 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

Cystoids macular edema (CME) is one of the most common causes of low vision due to uveitis. The treatment for reducing the intra-ocular inflammation can decrease the macular edema. In some patients, CME persists even after inflammation control, and additional treatment is needed for better vision. Oral steroid, periocular and intravitreal Triamcinolone are the principles in treatment, but some complications like cataracts and increased ocular pressure have been seen. Diclophenac is a non-steroid anti-inflammatory drug that improves the vision and decreases the macular thickness by slowing down the prostaglandin E2 (PGE2) ending in vascular endothelial growth factor (VEGF) inhibition. In this study, the investigators are going to compare the therapeutic affect of intravitreal Diclophenac and Triamcinolone in persistent uveitic cystoids macular edema. Since diclophenac is a cheap and accessible drug in all curative centers it could be applied instead of Triamcinolone.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• cystoids macular edema which is diagnosed by OCT and flurocein angiography

• 5/200 < Visual acuity < 20/50

• resistance to routine treatment (oral treatment, periocular injection)

Exclusion Criteria:

• history of retinal disease cause macular edema like diabetes

• arterial occlusion

• monocular patients

• patients candidate for intra-ocular operation

• history of glaucoma or ocular hypertension

• any cataract that would interfere with OCT

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystoid Macular Edema
• Edema
• Macular Edema
• Uveitis

Intervention

Drug:
• Diclophenac

• Triamcinolone

Locations

Country	Name	City	State
Iran, Islamic Republic of	Ophthalmic Research Center	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
hahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of,