NCT00893854

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.

Trial Health

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Trial Health Score

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Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 6, 2009

Completed
Last Updated

May 6, 2009

Status Verified

May 1, 2009

First QC Date

May 4, 2009

Last Update Submit

May 4, 2009

Conditions

Study Arms (2)

Diclophenac

EXPERIMENTAL
Drug: Diclophenac

Triamcinolone

EXPERIMENTAL
Drug: Triamcinolone

Interventions

Diclophenac
Triamcinolone

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • cystoids macular edema which is diagnosed by OCT and flurocein angiography
  • /200 \< Visual acuity \< 20/50
  • resistance to routine treatment (oral treatment, periocular injection)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ophthalmic Research Center

Tehran, Tehran Province, 166666, Iran

RECRUITING

MeSH Terms

Conditions

UveitisMacular Edema

Interventions

DiclofenacTriamcinolone

Condition Hierarchy (Ancestors)

Uveal DiseasesEye DiseasesMacular DegenerationRetinal DegenerationRetinal Diseases

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 4, 2009

First Posted

May 6, 2009

Last Updated

May 6, 2009

Record last verified: 2009-05

Locations