Abstract | BACKGROUND: To assess healthcare processes during treatment of neovascular age-related macular degeneration (AMD) in patients under real-life conditions and evaluate efficacy of monthly visual acuity (VA) assessment in a pro re nata treatment regime. METHODS: A multicentre, prospective, non-interventional study based in Germany included neovascular AMD patients treated with intravitreal ranibizumab. Patients completed a 3-month loading phase with monthly intravitreal injections of 0.5 mg ranibizumab, followed by a 12-month maintenance phase during which investigators documented VA, additional injections, metamorphopsias, routine ophthalmological examinations and adverse events at monthly follow-up visits. Efficacy analysis included change from baseline in best-corrected VA (BCVA) based on descriptive statistics. RESULTS: A total of 2,232 patients were enrolled throughout Germany and 1,729 patients (mean age 77.8 years, 63.2 % women) comprised the efficacy population with a complete set of data. In the clinical setting recorded in our study, only a minority of patients underwent optical coherence tomography during the maintenance phase (71 of 1,729 patients). Patients received a mean total of 4.5 injections; three injections during upload phase and 1.5 additional injections during maintenance phase. Over half of the patients (51.4 %) did not receive additional injections. Mean decimal BCVA increased during the upload phase, (from LogMAR mean of 0.201 at baseline to 0.219 at Month 4) but displayed a decline over time (0.192 at Month 15). CONCLUSION:
Ranibizumab treatment in a real-life setting demonstrated efficacy in neovascular AMD patients, as shown by initial gains in BCVA. However, maintenance and improvement of these gains during the maintenance phase in a clinical routine setting remained below those expected compared with MARINA, ANCHOR and CATT trials, most likely due to a low number of retreatments, and the high number of patients with a poor response in regard to improvements of VA who were not investigated in these studies. TRIAL REGISTRATION NUMBER: This phase IV non-interventional health services research study was conducted under the Novartis internal registration code, CRFB002ADE10.
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Authors | Armin Wolf, Anselm Kampik |
Journal | Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie
(Graefes Arch Clin Exp Ophthalmol)
Vol. 252
Issue 4
Pg. 647-55
(Apr 2014)
ISSN: 1435-702X [Electronic] Germany |
PMID | 24424409
(Publication Type: Clinical Trial, Phase IV, Journal Article, Multicenter Study, Observational Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Angiogenesis Inhibitors
- Antibodies, Monoclonal, Humanized
- VEGFA protein, human
- Vascular Endothelial Growth Factor A
- Ranibizumab
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Topics |
- Aged
- Aged, 80 and over
- Angiogenesis Inhibitors
(therapeutic use)
- Antibodies, Monoclonal, Humanized
(therapeutic use)
- Female
- Health Services Research
- Humans
- Intravitreal Injections
- Male
- Middle Aged
- Prospective Studies
- Ranibizumab
- Retreatment
- Tomography, Optical Coherence
- Treatment Outcome
- Vascular Endothelial Growth Factor A
(antagonists & inhibitors)
- Visual Acuity
(physiology)
- Wet Macular Degeneration
(diagnosis, drug therapy, physiopathology)
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