Original articleThe 1-year Results of CLEAR-IT 2, a Phase 2 Study of Vascular Endothelial Growth Factor Trap-Eye Dosed As-needed After 12-week Fixed Dosing
Section snippets
Study Design
The primary objectives of the study were to assess the effect of intravitreal VEGF Trap-Eye on CR/LT and to assess the ocular and systemic safety and tolerability of repeated doses of VEGF Trap-Eye in patients with choroidal neovascularization (CNV) associated with wet AMD. A key secondary objective was to assess the effect of VEGF Trap-Eye on BCVA.
This study was a double-masked, prospective, randomized, dose- and interval-ranging study in which 5 groups of approximately 30 patients each were
Patient Disposition
Of 159 patients who were randomized, 157 were treated and 134 (85.4%) completed 52 weeks in the study (Table 1 available online at http://aaojournal.org). For the 23 patients (14.6%) who were withdrawn before completion of 52 weeks, 6 (3.8%) withdrawals were at the request of the patient.
Baseline Characteristics
The study population was representative of the AMD population in the United States. Patients ranged in age from 53 to 94 years (mean, 78.3) and the majority were women (62%; Table 2). The mean time from
Discussion
Among patients with neovascular AMD, PRN dosing with VEGF Trap-Eye maintained efficacy established during a 12-week monthly or quarterly fixed-dosing phase for an additional 40 weeks. For all groups combined, a clinically significant improvement in visual acuity achieved at 12 weeks (5.7-letter gain) was maintained to 52 weeks (5.3-letter gain), accompanied by a decrease in CR/LT (−119 μm at week 12 and −130 μm at week 52). Among patients in all treatment groups combined, 22% experienced a gain
Acknowledgment
Technical writing and editorial assistance was provided by Meher Dustoor, PhD.
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Financial Disclosure(s): The authors have made the following disclosures:
Jeffrey S. Heier – Regeneron (C,S), Alcon (C), Genentech (C), Glaxosmithkline (C), Paloma (C), Neovista (C), Oraya (C).
David Boyer – Alcon (C,L), Genentech (C,L), Regeneron (C), Novartis (C), Pfizer (C), Eyetech (C), Allergan (C,L).
Quan Dong Nguyen – Genetech (S), Regeneron (S), Novartis (S), Pfizer (S), Lux Biosciences (S), Macu Sight (S), Bausch & Lomb (C).
Dennis Marcus – Genentech (C,S), Regeneron (S), Allergan (S), Neovista (S), Pfizer (S), Ophthotech (S), Alimaera (S).
Daniel B. Roth – Regeneron (C), Allergan (C), Notal Vision (C).
George Yancopoulos – Regeneron (E,O).
Neil Stahl – Regeneron Pharmaceuticals (E).
Avner Ingerman – Regeneron Pharmaceuticals (E).
Robert Vitti – Regeneron Pharmaceuticals (E).
Alyson J. Berliner – Regeneron Pharmaceuticals (E).
Ke Yang – Regeneron Pharmaceuticals (E, O).
David M. Brown – Thrombogenics(S), Molecular Partners (C,S), Schering Plough (S), Paloma (C,S), Alimaera (S), Ophthotech (S).
Supported by Regeneron Pharmaceuticals, Inc. and Bayer HealthCare AG. The sponsors participated in the design of the study, conducting the study, data collection, data management, data analysis, interpretation of the data, and the preparation, review and approval of the manuscript.
Manuscript no. 2010-1500.