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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified May 2009 by Shahid Beheshti University of Medical Sciences.
Recruitment status was: Recruiting

Sponsor:

Information provided by:

Shahid Beheshti University of Medical Sciences

ClinicalTrials.gov Identifier:

NCT00893854

First received: May 4, 2009

Last updated: NA

Last verified: May 2009

History: No changes posted

Purpose

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	Intervention	Phase
Uveitis Cystoid Macular Edema	Drug: Diclophenac Drug: Triamcinolone	Phase 1


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

Resource links provided by NLM:

MedlinePlus related topics: Edema

Drug Information available for: Triamcinolone diacetate Triamcinolone acetonide Triamcinolone Triamcinolone hexacetonide Diclofenac sodium Diclofenac potassium Diclofenac

Genetic and Rare Diseases Information Center resources: Uveal Diseases

U.S. FDA Resources

Further study details as provided by Shahid Beheshti University of Medical Sciences:

Arms	Assigned Interventions
Experimental: Diclophenac	Drug: Diclophenac
Experimental: Triamcinolone	Drug: Triamcinolone

Eligibility


Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00893854

Locations


Iran, Islamic Republic of
Ophthalmic Research Center	Recruiting
Tehran, Iran, Islamic Republic of, 166666
Contact: Masoud Soheilian, MD +98 21 22585952 labbafi@hotmail.com

Sponsors and Collaborators

Shahid Beheshti University of Medical Sciences

More Information


ClinicalTrials.gov Identifier:	NCT00893854 History of Changes
Other Study ID Numbers:	8727
Study First Received:	May 4, 2009
Last Updated:	May 4, 2009

Additional relevant MeSH terms:


Edema Macular Edema Uveitis Signs and Symptoms Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases Uveal Diseases Diclofenac Triamcinolone hexacetonide Triamcinolone Triamcinolone Acetonide Triamcinolone diacetate Anti-Inflammatory Agents, Non-Steroidal	Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Immunosuppressive Agents Immunologic Factors

ClinicalTrials.gov processed this record on July 19, 2017

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