Diffuse Diabetic Maculopathy With Intravitreal Triamcinolone or Laser

This study has been completed.

Sponsor:

Information provided by:

Hospital de Clinicas de Porto Alegre

ClinicalTrials.gov Identifier:

NCT00668239

First received: April 24, 2008

Last updated: April 28, 2008

Last verified: April 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

April 24, 2008

Last Updated Date

April 28, 2008

Start Date ^ICMJE

September 2004

Primary Completion Date

April 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

diffuse macular oedema [ Time Frame: 1, 3 and 6 months ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00668239 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

morphofunctional assessment of retina [ Time Frame: 1,3 and 6 monts ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Diffuse Diabetic Maculopathy With Intravitreal Triamcinolone or Laser

Official Title ^ICMJE

Treatment of Diffuse Diabetic Maculopathy With Intravitreal Triamcinolone and Laser Photocoagulation: Randomized Clinical Trial With Morphological and Functional Evaluation

Brief Summary

This study compares the use of intravitreous triamcinolone and laser therapy to treat maculopahty in patients with type 2 diabetes mellitus in a short-tem period of 6 months

Detailed Description

The purpose of this double blind randomized clinical trial was to compare the treatment of diffuse diabetic macular oedema with intravitreal triamcinolone and laser in patients with type 2 diabetes mellitus (DM), using a morphofunctional assessment. Patients with clinically significant diffuse macular oedema, previously untreated and with a macular thickness >250 μm at optical coherence tomography (OCT) were randomized for treatment with Laser or intravitreal injection of Triamcinolone acetate. Optical coherence tomography (OCT), biomicroscopy, fundoscopy, fluorescein angiography, tonometry, scotometry, visual acuity and contrast acuities were performed at 0, 1, 3 and 6 months.

Study Type ^ICMJE

Interventional

Study Phase

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Macular Edema

Intervention ^ICMJE

Drug: intravitreous triamcinolone
Intravenous injection of 0.1 ml (4 mg) of triamcinolone acetate was performed through the pars plana in a surgical environment. The medication used was manipulated by the Ophthalmos chemist. This type of formulation is different from the similar American one (Kenalog ®) since it does not use a conservation agent
Procedure: laser therapy
pan fotocoaglulation by laser therapy

Study Arm (s)

Active Comparator: 1
Laser treatment: laser was applied to the macular region according to the modified grid technique in inverted C, preserving 500 μ of the foveolus and avascular zone, with 100μ diameter shots, energy varying from 0.2 to 0.5 joules, with a time of exposure between 0.2 and 0.4 seconds. One hundred and fifty to 200 shots were applied according to the size of the retinal area². ND YAG laser (Crystal Focus (EMERED®) was used

Intervention: Procedure: laser therapy
Experimental: 2
triamcinolone as previously described

Intervention: Drug: intravitreous triamcinolone

Publications *

Gil AL, Azevedo MJ, Tomasetto GG, Muniz CH, Lavinsky J. Treatment of diffuse diabetic maculopathy with intravitreal triamcinolone and laser photocoagulation: randomized clinical trial with morphological and functional evaluation. Arq Bras Oftalmol. 2011 Sep-Oct;74(5):343-7.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2006

Primary Completion Date

April 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

patients with type 2 DM, diffuse macular oedema secondary to diabetic retinopathy, seen at the Centre of Reference for Diabetic Retinopathy at Hospital de Clinicas de Porto Alegre (HCPA) and at the Ophthalmology Outpatient Clinic at HCPA,

Exclusion Criteria:

patients with type 2 DM and previous treatment of diffuse macular oedema secondary to diabetic retinopathy

Gender

Both

Ages

30 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Brazil

Administrative Information

NCT Number ^ICMJE

NCT00668239

Other Study ID Numbers ^ICMJE

HCPA-04288

Has Data Monitoring Committee

Responsible Party

MIrela Jobim de Azevedo

Study Sponsor ^ICMJE

Hospital de Clinicas de Porto Alegre

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Alberto L Gil, MD

UFRGS

Information Provided By

Hospital de Clinicas de Porto Alegre

Verification Date

April 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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