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

Sponsor
Shahid Beheshti University of Medical Sciences (Other)
Overall Status
Unknown status
CT.gov ID
NCT00893854
Collaborator
(none)
1
Location
2
Arms

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
The Comparison Between the Therapeutic Affect of Intravitreal Diclophenac and Triamcinolone in Persistent Uveitic Cystoids Macular Edema

Arms and Interventions

Arm Intervention/Treatment
Experimental: Diclophenac

Drug: Diclophenac
Experimental: Triamcinolone

Drug: Triamcinolone

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ophthalmic Research Center Tehran Iran, Islamic Republic of 166666

    Sponsors and Collaborators

    • Shahid Beheshti University of Medical Sciences

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00893854
    Other Study ID Numbers:
    • 8727
    First Posted:
    May 6, 2009
    Last Update Posted:
    May 6, 2009
    Last Verified:
    May 1, 2009
    Additional relevant MeSH terms:
    Macular Edema
    Uveitis
    Edema
    Triamcinolone
    Diclofenac

    Study Results

    No Results Posted as of May 6, 2009