Diffuse Diabetic Maculopathy With Intravitreal Triamcinolone or Laser

Macular Edema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00668239
• Other study ID #: HCPA-04288
• Status: Completed
• Phase: N/A
• First received: April 24, 2008
• Last updated: April 28, 2008
• Start date: September 2004
• Est. completion date: June 2006

Study information

• Verified date: April 2008
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: June 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Macular Edema

Intervention

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

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande do Sul
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	RS
Brazil	HOspital de Clínicas de Porto alegre	Porto alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diffuse macular oedema		1, 3 and 6 months	Yes
Secondary	morphofunctional assessment of retina		1,3 and 6 monts	Yes