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Graefes Arch Clin Exp Ophthalmol. 2014 Apr;252(4):647-55. doi: 10.1007/s00417-013-2562-6. Epub 2014 Jan 15.

Efficacy of treatment with ranibizumab in patients with wet age-related macular degeneration in routine clinical care: data from the COMPASS health services research.

Author information

1
Augenklinik der LMU, Klinikum der Universität München, Campus Innenstadt, Mathildenstrasse 8, 80336, München, Germany, armin.wolf@med.uni-muenchen.de.

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.

PMID:
24424409
PMCID:
PMC3968520
DOI:
10.1007/s00417-013-2562-6
[Indexed for MEDLINE]
Free PMC Article

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