Diffuse Diabetic Maculopathy With Intravitreal Triamcinolone or Laser
Information source: Hospital de Clinicas de Porto Alegre
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Macular Edema
Intervention: intravitreous triamcinolone (Drug); laser therapy (Procedure)
Phase: N/A
Status: Completed
Sponsored by: Hospital de Clinicas de Porto Alegre Official(s) and/or principal investigator(s):
Alberto L Gil, MD, Principal Investigator, Affiliation: UFRGS
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
Clinical Details
Official title: Treatment of Diffuse Diabetic Maculopathy With Intravitreal Triamcinolone and Laser Photocoagulation: Randomized Clinical Trial With Morphological and Functional Evaluation
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: diffuse macular oedema
Secondary outcome: morphofunctional assessment of retina
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
Minimum age: 30 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
HOspital de Clínicas de Porto alegre, Porto alegre, RS 9035/903, Brazil
Hospital de Clínicas de Porto Alegre, Porto Alegre, RS 90035-003, Brazil
Hospital de Clínicas de Porto Alegre, Porto Alegre, Rio Grande do Sul 90630040, Brazil
Additional Information
Starting date: September 2004
Ending date: June 2006
Last updated: April 28, 2008
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