Diabetic Macular Edema, Diabetic Retinopathy
Conditions
Keywords
diabetic macular edema, triamcinolone acetonide, intravitreal, steroid
Brief summary
Efficacy duration of triamcinolone acetonide (steroid) for treatment of diabetic macular edema. Furthermore, dosage dependency of triamcinolone acetonide comparing a high dosage versus a low dosage.
Detailed description
Patients with diabetic retinopathy suffer from visual acuity loss caused by diabetic macular edema. Intravitreal injected Triamcinolone Acetonide (steroid) reduces macular edema and increases visual acuity. The duration of its effect is however limited. Therefore, several injections are necessary. In this study a dosage dependency of triamcinolone acetonide (high dosage vs low dosage) is performed. The primary outcome parameters are the number of treatments and the efficacy of each injection.
Interventions
DRUGIntravitreal injection (triamcinolone acetonide)
Sponsors
Heidelberg University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* diabetic macular edema and visual acuity between 20/200 and 20/40 age over 18 years
Exclusion criteria
* recent treatment with laser photocoagulation or intravitreal drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual acuity, no of treatments, duration of efficacy | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| intraocular pressure, retinal thickness | 12 months |
Countries
Germany
Contacts
Primary ContactUlrich HM Spandau, PhD MD
Backup ContactAnne Wickenhaeuser, MD
Outcome results
None listed