Diffuse Diabetic Maculopathy With Intravitreal Triamcinolone or Laser

NCT00668239 | Completed

• 1 other identifier: HCPA-04288
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 3

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

Conditions

Macular Edema

Keywords

diffuse macular oedema; type 2 diabetes mellitus; laser therapy

Outcome Measures

Primary Outcomes (1)

• diffuse macular oedema

  1, 3 and 6 months

Secondary Outcomes (1)

• morphofunctional assessment of retina

  1,3 and 6 monts

Study Arms (2)

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

2

EXPERIMENTAL

triamcinolone as previously described

Drug: intravitreous triamcinolone

Interventions

intravitreous triamcinolone 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

2

laser therapy PROCEDURE

pan fotocoaglulation by laser therapy

1

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

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

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (3)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

Location

HOspital de Clínicas de Porto alegre

Porto Alegre, Rio Grande do Sul, 9035/903, Brazil

Location

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90630040, Brazil

Location

Related Publications (1)

• 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.

  PMID: 22183994 DERIVED

MeSH Terms

Conditions

Macular Edema; Diabetes Mellitus, Type 2

Interventions

Laser Therapy

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Alberto L Gil, MD

  Federal University of Health Science of Porto Alegre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 24, 2008
• First Posted: April 29, 2008
• Study Start: September 1, 2004
• Primary Completion: April 1, 2006
• Study Completion: June 1, 2006
• Last Updated: April 29, 2008

Record last verified: 2008-04

Locations

BR (3)