David M Brown1, Ursula Schmidt-Erfurth2, Diana V Do3, Frank G Holz4, David S Boyer5, Edoardo Midena6, Jeffrey S Heier7, Hiroko Terasaki8, Peter K Kaiser9, Dennis M Marcus10, Quan D Nguyen3, Glenn J Jaffe11, Jason S Slakter12, Christian Simader2, Yuhwen Soo13, Thomas Schmelter14, George D Yancopoulos13, Neil Stahl13, Robert Vitti13, Alyson J Berliner13, Oliver Zeitz15, Carola Metzig14, Jean-François Korobelnik16. 1. Retina Consultants of Houston, Houston, Texas. 2. Medical University of Vienna, Vienna, Austria. 3. Truhlsen Eye Institute, University of Nebraska Medical Center, Omaha, Nebraska. 4. Department of Ophthalmology, University of Bonn, Bonn, Germany. 5. Retina-Vitreous Associates Medical Group, Beverly Hills, California. 6. Department of Ophthalmology, University of Padova, Padova, Italy. 7. Ophthalmic Consultants of Boston and Tufts University School of Medicine, Boston, Massachusetts. 8. Nagoya University Hospital, Nagoya, Japan. 9. Cole Eye Institute, Cleveland, Ohio. 10. Southeast Retina Center, Augusta, Georgia. 11. Department of Ophthalmology, Duke University, Durham, North Carolina. 12. Vitreous-Retina-Macula Consultants of New York, New York, New York. 13. Regeneron Pharmaceuticals, Inc, Tarrytown, New York. 14. Bayer HealthCare, Berlin, Germany. 15. Bayer HealthCare, Berlin, Germany; University Medical Center Hamburg-Eppendorf, Hamburg, Germany. 16. Service d'ophtalmologie, Hôpital Pellegrin-CHU de Bordeaux, Bordeaux, France; Université Bordeaux Segalen, Bordeaux, France; INSERM, ISPED, Centre INSERM U897-Epidemiologie-Biostatistique, Bordeaux, France. Electronic address: jean-francois.korobelnik@chu-bordeaux.fr.
Abstract
PURPOSE: To compare efficacy and safety of 2 dosing regimens of intravitreal aflibercept injection (IAI) with macular laser photocoagulation for diabetic macular edema (DME). DESIGN: Two similarly designed, randomized, phase 3 trials, VISTA(DME) and VIVID(DME). PARTICIPANTS: Patients (eyes; n=872) with type 1 or 2 diabetes mellitus who had DME with central involvement. METHODS: Eyes received IAI 2 mg every 4 weeks (2q4), IAI 2 mg every 8 weeks after 5 monthly doses (2q8), or laser control. MAIN OUTCOME MEASURES: The primary end point was mean change from baseline in best-corrected visual acuity (BCVA) at week 52. This report presents the 100-week results including mean change from baseline in BCVA, proportion of eyes that gained ≥15 letters, and proportion of eyes with a ≥2-step improvement in the Diabetic Retinopathy Severity Scale (DRSS) score. RESULTS:Mean BCVA gain from baseline to week 100 with IAI 2q4, IAI 2q8, and laser control was 11.5, 11.1, and 0.9 letters (P < 0.0001) in VISTA and 11.4, 9.4, and 0.7 letters (P < 0.0001) in VIVID, respectively. The proportion of eyes that gained ≥15 letters from baseline at week 100 was 38.3%, 33.1%, and 13.0% (P < 0.0001) in VISTA and 38.2%, 31.1%, and 12.1% (P ≤ 0.0001) in VIVID. The proportion of eyes that lost ≥15 letters at week 100 was 3.2%, 0.7%, and 9.7% (P ≤ 0.0220) in VISTA and 2.2%, 1.5%, and 12.9% (P ≤ 0.0008) in VIVID. Significantly more eyes in the IAI 2q4 and 2q8 groups versus those in the laser control group had a ≥2 step improvement in the DRSS score in both VISTA (37.0% and 37.1% vs. 15.6%; P < 0.0001) and VIVID (29.3% and 32.6% vs. 8.2%; P ≤ 0.0004). In an integrated safety analysis, the most frequent serious ocular adverse event was cataract (2.4%, 1.0%, and 0.3% for 2q4, 2q8, and control). CONCLUSIONS: In both VISTA and VIVID, the 52-week visual and anatomic superiority of IAI over laser control was sustained through week 100, with similar efficacy in the 2q4 and 2q8 groups. Safety in these studies was consistent with the known safety profile of IAI.
RCT Entities:
PURPOSE: To compare efficacy and safety of 2 dosing regimens of intravitreal aflibercept injection (IAI) with macular laser photocoagulation for diabetic macular edema (DME). DESIGN: Two similarly designed, randomized, phase 3 trials, VISTA(DME) and VIVID(DME). PARTICIPANTS: Patients (eyes; n=872) with type 1 or 2 diabetes mellitus who had DME with central involvement. METHODS: Eyes received IAI 2 mg every 4 weeks (2q4), IAI 2 mg every 8 weeks after 5 monthly doses (2q8), or laser control. MAIN OUTCOME MEASURES: The primary end point was mean change from baseline in best-corrected visual acuity (BCVA) at week 52. This report presents the 100-week results including mean change from baseline in BCVA, proportion of eyes that gained ≥15 letters, and proportion of eyes with a ≥2-step improvement in the Diabetic Retinopathy Severity Scale (DRSS) score. RESULTS: Mean BCVA gain from baseline to week 100 with IAI 2q4, IAI 2q8, and laser control was 11.5, 11.1, and 0.9 letters (P < 0.0001) in VISTA and 11.4, 9.4, and 0.7 letters (P < 0.0001) in VIVID, respectively. The proportion of eyes that gained ≥15 letters from baseline at week 100 was 38.3%, 33.1%, and 13.0% (P < 0.0001) in VISTA and 38.2%, 31.1%, and 12.1% (P ≤ 0.0001) in VIVID. The proportion of eyes that lost ≥15 letters at week 100 was 3.2%, 0.7%, and 9.7% (P ≤ 0.0220) in VISTA and 2.2%, 1.5%, and 12.9% (P ≤ 0.0008) in VIVID. Significantly more eyes in the IAI 2q4 and 2q8 groups versus those in the laser control group had a ≥2 step improvement in the DRSS score in both VISTA (37.0% and 37.1% vs. 15.6%; P < 0.0001) and VIVID (29.3% and 32.6% vs. 8.2%; P ≤ 0.0004). In an integrated safety analysis, the most frequent serious ocular adverse event was cataract (2.4%, 1.0%, and 0.3% for 2q4, 2q8, and control). CONCLUSIONS: In both VISTA and VIVID, the 52-week visual and anatomic superiority of IAI over laser control was sustained through week 100, with similar efficacy in the 2q4 and 2q8 groups. Safety in these studies was consistent with the known safety profile of IAI.
Authors: Susan B Bressler; Danni Liu; Adam R Glassman; Barbara A Blodi; Alessandro A Castellarin; Lee M Jampol; Paul L Kaufman; Michele Melia; Harinderjit Singh; John A Wells Journal: JAMA Ophthalmol Date: 2017-06-01 Impact factor: 7.389
Authors: Jennifer K Sun; Adam R Glassman; Wesley T Beaulieu; Cynthia R Stockdale; Neil M Bressler; Christina Flaxel; Jeffrey G Gross; Michel Shami; Lee M Jampol Journal: Ophthalmology Date: 2018-08-07 Impact factor: 12.079
Authors: Neil M Bressler; Wesley T Beaulieu; Maureen G Maguire; Adam R Glassman; Kevin J Blinder; Susan B Bressler; Victor H Gonzalez; Lee M Jampol; Michele Melia; Jennifer K Sun; John A Wells Journal: Am J Ophthalmol Date: 2018-08-02 Impact factor: 5.258