Victor H Gonzalez1, David S Boyer, Ursula Schmidt-Erfurth, Jeffrey S Heier, Carmelina Gordon, Matthew S Benz, Dennis M Marcus, Nelson R Sabates, Robert Vitti, Husain Kazmi, Alyson J Berliner, Yuhwen Soo, Xiaoping Zhu, Hadi Moini, Oliver Zeitz, Rupert Sandbrink, Diana V Do. 1. *Valley Retina Institute, McAllen, Texas; †Retina-Vitreous Associates Medical Group, Beverly Hills, California; ‡Department of Ophthalmology, Medical University of Vienna, Vienna, Austria; §Ophthalmic Consultants of Boston and Tufts University School of Medicine, Boston, Massachusetts; ¶TLC EyeCare and Laser Center, Jackson, Michigan; **Retina Consultants of Houston, Houston, Texas; ††Southeast Retina Center, Augusta, Georgia; ‡‡Department of Ophthalmology, University of Missouri-Kansas City School of Medicine, Kansas City, Missouri; §§Regeneron Pharmaceuticals, Inc, Tarrytown, New York; ¶¶Bayer Healthcare, Berlin, Germany; ***Klinik und Poliklinik für Augenheilkunde, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany; †††Department of Neurology, Heinrich-Heine Universität, Düsseldorf, Germany; and ‡‡‡Department of Ophthalmology, Truhlsen Eye Institute, University of Nebraska Medical Center, Omaha, Nebraska.
Abstract
PURPOSE: To evaluate retinal sensitivity in patients with diabetic macular edema who receivedintravitreal aflibercept injection (IAI) or laser. METHODS: A substudy included 46 patients from DA VINCI (a randomized, double-masked Phase 2 study) receiving eitherlaser, 0.5 mg IAI every 4 weeks, 2 mg IAI every 4 weeks, 2 mg IAI every 8 weeks after 3 monthly doses (2q8), or 2 mg IAI as-needed after 3 monthly doses for 52 weeks. Retinal sensitivity was measured in one (central), five (one central and four inner), and eight (four inner and four outer) optical coherence tomography subfields. RESULTS:Mean best-corrected visual acuity improvement in the subgroup at Week 52 was 3.3 letters with laser and ranged from 5.4 to 16.3 letters in the IAI groups. Retinal sensitivity of laser patients at Week 52 was comparable with baseline in the central optical coherence tomography subfield but decreased in the five and eight optical coherence tomography subfields. Compared with laser, retinal sensitivity significantly increased with IAI in the 2q8 and pooled IAI groups in the 5 and 8 optical coherence tomography subfields at Week 52 (P < 0.05). CONCLUSION:Intravitreal aflibercept injection improved best-corrected visual acuity and retinal sensitivity in this subgroup of patients. Laser may cause a deterioration of macular function that is not detectable with best-corrected visual acuity testing.
RCT Entities:
PURPOSE: To evaluate retinal sensitivity in patients with diabetic macular edema who received intravitreal aflibercept injection (IAI) or laser. METHODS: A substudy included 46 patients from DA VINCI (a randomized, double-masked Phase 2 study) receiving either laser, 0.5 mg IAI every 4 weeks, 2 mg IAI every 4 weeks, 2 mg IAI every 8 weeks after 3 monthly doses (2q8), or 2 mg IAI as-needed after 3 monthly doses for 52 weeks. Retinal sensitivity was measured in one (central), five (one central and four inner), and eight (four inner and four outer) optical coherence tomography subfields. RESULTS: Mean best-corrected visual acuity improvement in the subgroup at Week 52 was 3.3 letters with laser and ranged from 5.4 to 16.3 letters in the IAI groups. Retinal sensitivity of laser patients at Week 52 was comparable with baseline in the central optical coherence tomography subfield but decreased in the five and eight optical coherence tomography subfields. Compared with laser, retinal sensitivity significantly increased with IAI in the 2q8 and pooled IAI groups in the 5 and 8 optical coherence tomography subfields at Week 52 (P < 0.05). CONCLUSION: Intravitreal aflibercept injection improved best-corrected visual acuity and retinal sensitivity in this subgroup of patients. Laser may cause a deterioration of macular function that is not detectable with best-corrected visual acuity testing.
Authors: Quan Dong Nguyen; Sandro De Falco; Francine Behar-Cohen; Wai-Ching Lam; Xuri Li; Nadine Reichhart; Federico Ricci; Jennifer Pluim; William W Li Journal: Acta Ophthalmol Date: 2016-11-22 Impact factor: 3.761