Diabetic Macular Edema
Conditions
Keywords
bevacizumab, diabetic macular edema, triamcinolone
Brief summary
One of the most frequent complications of diabetic retinopathy is diabetic macular edema. Recently, intravitreal bevacizumab and intravitreal triamcinolone were the most popular therapeutic modalities. However, as the long term effects of intravitreal bevacizumab and intravitreal triamcinolone on visual acuity and macular thickness have not been compared, it was the purpose of the present study to compare these treatment effects
Detailed description
Randomization of intravitreal bevacizumab, intravitreal triamcinolone, intravitreal bevacizumab with triamcinolone on eyes with diabetic macular edema
Interventions
PROCEDUREIntravitreal injection
Intravitreal Injections were done under sterile conditions with topical anesthesia and insertion of a lid speculum. For the bevacizumab group, 1.25 mg (0.05 cc) bevacizumab (Avastin, made for F. Hoffmann-La Roche Ltd Basel, Switzerland by Genentech Inc., San Francisco, CA, USA) was injected intravitreally with a 30-gauge needle through the superotemporal quadrant. For the bevacizumab with triamcinolone group, in addition to intravitreal bevacizumab, 2 mg(0.05 cc) triamcinolone acetonide (Triamhexal, Hexal AG,Holzkirchen, Germany) was injected intravitreally through the inferotemporal quadrant. For triamcinolone group, 2 mg (0.05 cc) triamcinolone acetonide (Triamhexal, Hexal AG,Holzkirchen, Germany) was injected intravitreally.
Sponsors
Hallym University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diabetic macular edema (central macular thickness greater than 300 mm on optical coherence tomography )
Exclusion criteria
* history of glaucoma or ocular hypertension (defined as an intraocular pressure higher than 22 mmHg) * an ocular condition (other than diabetes) that, in the opinion of the investigator, might affect macular oedema or alter visual acuity during the course of the study (e.g. retinal vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, Irvine-Gass Syndrome, etc.) * systemic corticosteroid therapy history of thromboembolic event (including myocardial infarction or cerebral vascular accident) * major surgery within the prior 6 months or planned within the next 28 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual acuity | baseline, 1 month, 3 months, 6month, 9 month, 12 month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Central macular thickness | baseline, 1 month, 3 months, 6 months, 12months | analyzed by optical coherence tomography |
Countries
South Korea
Outcome results
None listed