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

NCT ID: NCT00893854

Last Updated: 2009-05-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL

Brief 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.

Conditions

Uveitis; Cystoid Macular Edema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Diclophenac

Group Type: EXPERIMENTAL

Diclophenac

Intervention Type: DRUG

Triamcinolone

Group Type: EXPERIMENTAL

Triamcinolone

Intervention Type: DRUG

Interventions

Diclophenac

Intervention Type: DRUG

Triamcinolone

Intervention Type: DRUG

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role: lead

Locations

Ophthalmic Research Center

Tehran, Tehran Province, Iran

Site Status: RECRUITING

Countries

Iran

Facility Contacts

Masoud Soheilian, MD

Role: primary

labbafi@hotmail.com

+98 21 22585952

Other Identifiers

8727

Identifier Type: -

Identifier Source: org_study_id