drugset / Trial / NCT00682539
Intraocular Anti-VEGF Compared With Intraocular Triamcinolone in Patients With Diabetic Macular Edema
RandomizedParallel-groupTriple-blindTreatment
Summary
The purpose of this study is to investigate the change in macular edema and the absolute change in visual acuity following intravitreal administered injections of Bevacizumab (Avastin®) or Ranibizumab (Lucentis®) compared with Triamcinolone (Volon A®) in patients with clinical significant diabetic macular edema. The investigators monitor the change in macular edema measured with standard optical coherence tomography (OCT) and the absolute change in visual acuity analyzed by standardized charts according to the protocol used in the Early Retreatment in Diabetic Retinopathy Study (ETDRS).
Timeline
- Start
- 2007-10
- Primary completion
- 2014-07
- Completion
- 2014-07
Publications
- Rittiphairoj T, Mir TA, Li T, Virgili G. Intravitreal steroids for macular edema in diabetes. Cochrane Database Syst Rev. 2020 Nov 17;11(11):CD005656. doi: 10.1002/14651858.CD005656.pub3.
- Karst SG, Lammer J, Mitsch C, Schober M, Mehta J, Scholda C, Kundi M, Kriechbaum K, Schmidt-Erfurth U. Detailed analysis of retinal morphology in patients with diabetic macular edema (DME) randomized to ranibizumab or triamcinolone treatment. Graefes Arch Clin Exp Ophthalmol. 2018 Jan;256(1):49-58. doi: 10.1007/s00417-017-3828-1. Epub 2017 Oct 28.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bevacizumab | Monoclonal antibody | 2.5 mg | Intravitreal |
| Comparator | Triamcinolone | Other / unclassified | 8 mg | Intravitreal |