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

AbstractBACKGROUND:
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.
AuthorsArmin Wolf, Anselm Kampik
JournalGraefe'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
PMID24424409 (Publication Type: Clinical Trial, Phase IV, Journal Article, Multicenter Study, Observational Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Angiogenesis Inhibitors
  • Antibodies, Monoclonal, Humanized
  • VEGFA protein, human
  • Vascular Endothelial Growth Factor A
  • Ranibizumab
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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