Victor H Gonzalez1, Joanna Campbell2, Nancy M Holekamp3, Szilárd Kiss4, Anat Loewenstein5, Albert J Augustin6, Julia Ma2, Allen C Ho7, Vaishali Patel2, Scott M Whitcup8, Pravin U Dugel9. 1. Valley Retina Institute, McAllen, Texas. Electronic address: maculadoc@aol.com. 2. Allergan plc, Irvine, California. 3. Pepose Vision Institute and Washington University School of Medicine, St Louis, Missouri. 4. Weill Cornell Medical College, New York, New York. 5. Department of Ophthalmology, Tel Aviv Medical Center and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. 6. Department of Ophthalmology, Staedtisches Klinikum Karlsruhe, Karlsruhe, Germany. 7. Wills Eye Hospital, Philadelphia, Pennsylvania. 8. Jules Stein Eye Institute, David Geffen School of Medicine at UCLA, Los Angeles, California. 9. Retinal Consultants of Arizona, Phoenix, Arizona; Department of Ophthalmology, Keck School of Medicine, University of Southern California, Los Angeles, California.
Abstract
PURPOSE: To determine whether early visual acuity response to ranibizumab in diabetic macular edema is associated with long-term outcome. DESIGN: Post hoc analysis of randomized controlled trial data. METHODS: Pooled data from the ranibizumab plus prompt and deferred laser treatment arms of the Diabetic Retinopathy Clinical Research Network's Protocol I study were used to explore the relationship between early (week 12) and late (weeks 52-156) visual acuity response (mean change from baseline in best-corrected visual acuity [CFB BCVA]; categorized improvement [<5, 5-9, or ≥10 Early Treatment Diabetic Retinopathy Study (ETDRS) letters] in BCVA). RESULTS: In the analysis population (340 eyes), <5-, 5- to 9-, and ≥10-letter BCVA improvements occurred in 39.7%, 23.2%, and 37.1% of eyes, respectively, at 12 weeks, and 34.2%, 16.5%, and 49.3% of eyes at 156 weeks. Within each early BCVA response category (<5, 5-9, and ≥10 letters of improvement at 12 weeks), mean CFB BCVA at 52-156 weeks varied by <5 letters from that at 12 weeks. CFB BCVA and <5-letter improvement at 12 weeks showed significant positive and negative association, respectively, with CFB BCVA and ≥10-letter improvement at 52 and 156 weeks. Similar relationships were demonstrated in eyes with baseline BCVA <69 letters, and associations remained significant after multivariate adjustment for potential confounders. CONCLUSIONS:Ranibizumab ±laser therapy resulted in similar rates (∼40%) of suboptimal (<5-letter) and pronounced (≥10-letter) BCVA improvement at 12 weeks. Eyes with suboptimal early BCVA response showed poorer long-term visual outcomes than eyes with pronounced early response (mean improvement 3.0 vs 13.8 letters at 156 weeks).
RCT Entities:
PURPOSE: To determine whether early visual acuity response to ranibizumab in diabetic macular edema is associated with long-term outcome. DESIGN: Post hoc analysis of randomized controlled trial data. METHODS: Pooled data from the ranibizumab plus prompt and deferred laser treatment arms of the Diabetic Retinopathy Clinical Research Network's Protocol I study were used to explore the relationship between early (week 12) and late (weeks 52-156) visual acuity response (mean change from baseline in best-corrected visual acuity [CFB BCVA]; categorized improvement [<5, 5-9, or ≥10 Early Treatment Diabetic Retinopathy Study (ETDRS) letters] in BCVA). RESULTS: In the analysis population (340 eyes), <5-, 5- to 9-, and ≥10-letter BCVA improvements occurred in 39.7%, 23.2%, and 37.1% of eyes, respectively, at 12 weeks, and 34.2%, 16.5%, and 49.3% of eyes at 156 weeks. Within each early BCVA response category (<5, 5-9, and ≥10 letters of improvement at 12 weeks), mean CFB BCVA at 52-156 weeks varied by <5 letters from that at 12 weeks. CFB BCVA and <5-letter improvement at 12 weeks showed significant positive and negative association, respectively, with CFB BCVA and ≥10-letter improvement at 52 and 156 weeks. Similar relationships were demonstrated in eyes with baseline BCVA <69 letters, and associations remained significant after multivariate adjustment for potential confounders. CONCLUSIONS:Ranibizumab ± laser therapy resulted in similar rates (∼40%) of suboptimal (<5-letter) and pronounced (≥10-letter) BCVA improvement at 12 weeks. Eyes with suboptimal early BCVA response showed poorer long-term visual outcomes than eyes with pronounced early response (mean improvement 3.0 vs 13.8 letters at 156 weeks).
Authors: I Chatziralli; M Santarelli; N Patrao; L Nicholson; M Zola; R Rajendram; P Hykin; S Sivaprasad Journal: Eye (Lond) Date: 2017-06-16 Impact factor: 3.775
Authors: Roxane J Hillier; Elvis Ojaimi; David T Wong; Michael Y K Mak; Alan R Berger; Radha P Kohly; Peter J Kertes; Farzin Forooghian; Shelley R Boyd; Kenneth Eng; Filiberto Altomare; Louis R Giavedoni; Rosane Nisenbaum; Rajeev H Muni Journal: JAMA Ophthalmol Date: 2018-04-01 Impact factor: 7.389
Authors: Neil M Bressler; Wesley T Beaulieu; Adam R Glassman; Kevin J Blinder; Susan B Bressler; Lee M Jampol; Michele Melia; John A Wells Journal: JAMA Ophthalmol Date: 2018-03-01 Impact factor: 7.389
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