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Diffuse Diabetic Maculopathy With Intravitreal Triamcinolone or Laser

NCT ID: NCT00668239

Last Updated: 2008-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2006-06-30

Brief Summary

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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

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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.

Conditions

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Macular Edema

Keywords

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diffuse macular oedema type 2 diabetes mellitus laser therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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

Group Type ACTIVE_COMPARATOR

laser therapy

Intervention Type PROCEDURE

pan fotocoaglulation by laser therapy

2

triamcinolone as previously described

Group Type EXPERIMENTAL

intravitreous triamcinolone

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

laser therapy

pan fotocoaglulation by laser therapy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role lead

Responsible Party

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MIrela Jobim de Azevedo

Principal Investigators

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Alberto L Gil, MD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Health Science of Porto Alegre

Locations

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Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

HOspital de Clínicas de Porto alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

References

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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. doi: 10.1590/s0004-27492011000500007.

Reference Type DERIVED
PMID: 22183994 (View on PubMed)

Other Identifiers

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HCPA-04288

Identifier Type: -

Identifier Source: org_study_id