Diffuse Diabetic Maculopathy With Intravitreal Triamcinolone or Laser - Full Text View

Sponsor:	Hospital de Clinicas de Porto Alegre
Information provided by:	Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:	NCT00668239

Purpose

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

Condition	Intervention
Macular Edema	Drug: intravitreous triamcinolone Procedure: laser therapy

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Treatment of Diffuse Diabetic Maculopathy With Intravitreal Triamcinolone and Laser Photocoagulation: Randomized Clinical Trial With Morphological and Functional Evaluation

Resource links provided by NLM:

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Diabetes Edema

Drug Information available for: Triamcinolone diacetate Triamcinolone acetonide Triamcinolone Triamcinolone hexacetonide

U.S. FDA Resources

Further study details as provided by Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Enrollment:	14
Study Start Date:	September 2004
Study Completion Date:	June 2006
Primary Completion Date:	April 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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	Procedure: laser therapy pan fotocoaglulation by laser therapy
2: Experimental triamcinolone as previously described	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

Arms

Assigned Interventions

1: Active Comparator

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

Procedure: laser therapy

pan fotocoaglulation by laser therapy

2: Experimental

triamcinolone as previously described

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

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.

Eligibility

Ages Eligible for Study:	30 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00668239

Locations

Brazil, Rio Grande do Sul
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90630040
Brazil, RS
HOspital de Clínicas de Porto alegre
Porto alegre, RS, Brazil, 9035/903
Hospital de Clínicas de Porto Alegre
Porto Alegre, RS, Brazil, 90035-003

Sponsors and Collaborators

Hospital de Clinicas de Porto Alegre

Investigators

Principal Investigator:

Alberto L Gil, MD

UFRGS

More Information

No publications provided

Responsible Party:	MIrela Jobim de Azevedo ( MIrela Jobim de Azevedo )
Study ID Numbers:	HCPA-04288
Study First Received:	April 24, 2008
Last Updated:	April 28, 2008
ClinicalTrials.gov Identifier:	NCT00668239 History of Changes
Health Authority:	Brazil: National Committee of Ethics in Research

Keywords provided by Hospital de Clinicas de Porto Alegre:

diffuse macular oedema
type 2 diabetes mellitus
laser therapy

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Eye Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Edema
Macular Degeneration
Retinal Degeneration
Enzyme Inhibitors
Triamcinolone diacetate

Immunosuppressive Agents
Hormones
Glucocorticoids
Pharmacologic Actions
Triamcinolone hexacetonide
Macular Edema
Signs and Symptoms
Triamcinolone Acetonide
Therapeutic Uses
Triamcinolone
Retinal Diseases

ClinicalTrials.gov processed this record on February 08, 2010