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A Randomized, Placebo-Controlled Clinical Trial of Intravitreal Triamcinolone for Refractory Diabetic Macular Edema

Primary Purpose

Diabetic Macular Edema

Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Triamcinolone acetonide
Sponsored by
Shahid Beheshti University of Medical Sciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Macular Edema focused on measuring Cystoid macular edema, Diabetic macular edema, Hard exudates, Intravitreal triamcinolone, Macular thickness

Eligibility Criteria

44 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Clinically significant macular edema(CSME) Clinically significant macular edema(CSME)refractory to initial or supplemental macular photocoagulation Exclusion Criteria: Mono-ocular patients History of vitrectomy Glaucoma or ocular hypertension Significant media opacity Traction on the macula

Sites / Locations

  • Labbafinejad Medical Center

Outcomes

Primary Outcome Measures

Central macular thickness

Secondary Outcome Measures

Visual acuity
intraocular pressure
Cataract progression
Cystoid macular edema
Macular hard exudates
Macular leakage severity in FA

Full Information

First Posted
August 29, 2006
Last Updated
February 27, 2007
Sponsor
Shahid Beheshti University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00369863
Brief Title
A Randomized, Placebo-Controlled Clinical Trial of Intravitreal Triamcinolone for Refractory Diabetic Macular Edema
Study Type
Interventional

2. Study Status

Record Verification Date
February 2007
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Shahid Beheshti University of Medical Sciences

4. Oversight

5. Study Description

Brief Summary
To determine the efficacy and safety of intravitreal triamcinolone acetonide for refractory diabetic macular edema.
Detailed Description
Overall 80% of diabetic patients with low vision are in the nonproliferative stage and the main cause of decreased visual acuity is macular edema. According to the early treatment diabetic retinopathy study (ETDRS), the treatment of choice for diabetic macular edema (DME) is laser therapy, which may be neither effective nor curative in some patients.There are many cases which are refractory to laser treatment or not suitable candidates for it. Corticosteroids might have a beneficial effect on DME. They have been used with different doses and routes (periocular,intravitreal,and slow released implants) for a variety of retinal diseases. Recently, a few prospective randomized studies, concerning the effect of intravitreal triamcinolone acetonide (IVT) on DME have been published. In their two-year results, Gillies et al. concluded that IVT improved vision and reduced macular thickness in eyes with refractory diabetic macular edema. They showed that this beneficial effect persisted for up to 2 years with repeated treatment. We also conducted a randomized placebo-controlled clinical trial to determine the safety and efficacy of IVT for intractable DME. Besides, we tried to evaluate the effect of this intervention on angiographic findings of these patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema
Keywords
Cystoid macular edema, Diabetic macular edema, Hard exudates, Intravitreal triamcinolone, Macular thickness

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
76 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Triamcinolone acetonide
Primary Outcome Measure Information:
Title
Central macular thickness
Secondary Outcome Measure Information:
Title
Visual acuity
Title
intraocular pressure
Title
Cataract progression
Title
Cystoid macular edema
Title
Macular hard exudates
Title
Macular leakage severity in FA

10. Eligibility

Sex
All
Minimum Age & Unit of Time
44 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinically significant macular edema(CSME) Clinically significant macular edema(CSME)refractory to initial or supplemental macular photocoagulation Exclusion Criteria: Mono-ocular patients History of vitrectomy Glaucoma or ocular hypertension Significant media opacity Traction on the macula
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammad - Hossein Dehghan, MD
Organizational Affiliation
Ophthalmic Research Center of Shaheed Beheshti Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Labbafinejad Medical Center
City
Tehran
ZIP/Postal Code
16666
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

A Randomized, Placebo-Controlled Clinical Trial of Intravitreal Triamcinolone for Refractory Diabetic Macular Edema

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