Original articleEfficacy and Safety of Monthly versus Quarterly Ranibizumab Treatment in Neovascular Age-related Macular Degeneration: The EXCITE Study
Section snippets
Study Design
The EXCITE study was a 1-year, randomized, double-masked, active-controlled, multicenter, Phase IIIb study in patients with subfoveal CNV secondary to AMD, comparing the efficacy and safety of quarterly dosing regimens of ranibizumab with a monthly dosing regimen during the maintenance phase, that is, from month 3 onward.
Eligible patients were randomly assigned in a 1:1:1 ratio to any of the following 3 double-masked treatment arms (Fig 1): loading doses of 3 initial monthly intravitreal
Patients
A total of 482 patients were screened and 353 patients were randomized for treatment with the study medication. As per the study design, patients received ranibizumab 0.3 mg quarterly (120 patients), ranibizumab 0.5 mg quarterly (118 patients), or ranibizumab 0.3 mg monthly dosing (115 patients). The PP population included 104 patients (86.7%) from the 0.3 mg quarterly, 88 (74.6%) from the 0.5 mg quarterly, and 101 (87.8%) from the 0.3 mg monthly dosing groups. The study was completed by 106
Discussion
The EXCITE trial is the first study directly comparing visual outcomes between monthly and quarterly dosing regimens in the treatment of patients with subfoveal CNV, secondary to AMD. The EXCITE study offers a rigorous analysis of the quarterly treatment regimen, with monthly study visits and OCT assessments, providing a monthly monitoring of functional and anatomic changes in the study eye. The EXCITE study allows to (1) compare the study outcome under monthly vs. quarterly treatment and (2)
Acknowledgments
The authors acknowledge medical writing assistance from Ajithkumar Vasudevan, PhD, and Shivani Mittra, PhD, Novartis Healthcare Pvt Ltd.
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Cited by (0)
*Group members listed online in Appendix 1 (available at http://aaojournal.org).
Manuscript no. 2009-1732.
Financial Disclosure(s): The authors have made the following disclosures: Ursula Schmidt-Erfurth – Consultant – Alcon Laboratories Inc., Bayer Healthcare, Carl Zeiss Meditec, Heidelberg Engineering Inc., Novartis Pharmaceutical Corporation, Regeneron; Research Grant – Bayer Healthcare, Carl Zeiss Meditec, Novartis Pharmaceutical Corporation Bora Eldem – Lecture Fee, Financial Support for this project – Novartis Pharmaceuticals Corporation Robyn Guymer – Consultant – Novartis Pharmaceuticals Corporation Jean-Francois Korobelnik – Consultant –Alcon Laboratories, Bayer Healthcare, Novartis Pharmaceuticals Corporation, THEA Reinier Schlingemann – Consultant, Lecture Fee – Novartis Pharmaceuticals Corporation Peter Wiedemann – Lecture Fee – Novartis Pharmaceutical Corporation Christian Simader – Consultant – Novartis Pharmaceutical Corporation Margarita Gekkieva –Employee – Novartis Pharma Andreas Weichselberger –Employee – Novartis Pharma Supported by Novartis Pharma, AG, Switzerland.
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A list of the primary investigators for the EXCITE study is available at http://aaojournal.org.