Dexamethasone intravitreal implant in previously treated patients with diabetic macular edema: subgroup analysis of the MEAD study
| Autor: | Augustin, Albert J, Kuppermann, Baruch D, Lanzetta, Paolo, Loewenstein, Anat, Li, Xiao-Yan, Cui, Harry, Hashad, Yehia, Whitcup, Scott M, Ozurdex MEAD Study Group |
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| Rok vydání: | 2015 |
| Předmět: |
Vascular Endothelial Growth Factor A
Male genetic structures Clinical Trials and Supportive Activities Visual Acuity Angiogenesis Inhibitors Eye Ophthalmology & Optometry Triamcinolone Acetonide Dexamethasone Macular Edema Clinical Research Diabetic retinopathy Opthalmology and Optometry Humans Corticosteroid Glucocorticoids Tomography Eye Disease and Disorders of Vision Aged Drug Implants Diabetes Evaluation of treatments and therapeutic interventions Implant Ozurdex MEAD Study Group Middle Aged eye diseases Optical Coherence 6.1 Pharmaceuticals Retreatment Intravitreal Injections Drug delivery Female Immunosuppressive Agents |
| Zdroj: | BMC ophthalmology, vol 15, iss 1 |
| Popis: | BackgroundDexamethasone intravitreal implant 0.7 mg (DEX 0.7) was approved for treatment of diabetic macular edema (DME) after demonstration of its efficacy and safety in the MEAD registration trials. We performed subgroup analysis of MEAD study results to evaluate the efficacy and safety of DEX 0.7 treatment in patients with previously treated DME.MethodsThree-year, randomized, sham-controlled phase 3 study in patients with DME, best-corrected visual acuity (BCVA) of 34-68 Early Treatment Diabetic Retinopathy Study letters (20/200-20/50 Snellen equivalent), and central retinal thickness (CRT) ≥ 300 μm measured by time-domain optical coherence tomography. Patients were randomized to 1 of 2 doses of DEX (0.7 mg or 0.35 mg), or to sham procedure, with retreatment no more than every 6 months. The primary endpoint was ≥ 15-letter gain in BCVA at study end. Average change in BCVA and CRT from baseline during the study (area-under-the-curve approach) and adverse events were also evaluated. The present subgroup analysis evaluated outcomes in patients randomized to DEX 0.7 (marketed dose) or sham based on prior treatment for DME at study entry.ResultsBaseline characteristics of previously treated DEX 0.7 (n = 247) and sham (n = 261) patients were similar. In the previously treated subgroup, mean number of treatments over 3 years was 4.1 for DEX 0.7 and 3.2 for sham, 21.5% of DEX 0.7 patients versus 11.1 % of sham had ≥ 15-letter BCVA gain from baseline at study end (P = 0.002), mean average BCVA change from baseline was +3.2 letters with DEX 0.7 versus +1.5 letters with sham (P = 0.024), and mean average CRT change from baseline was -126.1 μm with DEX 0.7 versus -39.0 μm with sham (P |
| Databáze: | OpenAIRE |
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