Gui-shuang Ying1, Maureen G Maguire2, Ebenezer Daniel2, Frederick L Ferris3, Glenn J Jaffe4, Juan E Grunwald2, Cynthia A Toth4, Jiayan Huang2, Daniel F Martin5. 1. Department of Ophthalmology, University of Pennsylvania, Philadelphia, Pennsylvania. Electronic address: gsying@mail.med.upenn.edu. 2. Department of Ophthalmology, University of Pennsylvania, Philadelphia, Pennsylvania. 3. National Eye Institute, National Institutes of Health, Bethesda, Maryland. 4. Department of Ophthalmology, Duke University, Durham, North Carolina. 5. Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio.
Abstract
PURPOSE: To evaluate the association of baseline characteristics and early visual acuity (VA) response with visual outcomes at years 1 or 2 in the Comparison of Age-Related Macular Degeneration (AMD) Treatments Trials (CATT). DESIGN: Secondary analysis of CATT. PARTICIPANTS: The 1185 CATT participants with baseline VA of 20/25 to 20/320. METHODS: Participants were assigned to ranibizumab or bevacizumab and to 1 of 3 dosing regimens. Associations of baseline characteristics and early VA response (week 4 or 12) with VA response at years 1 or 2 were assessed by R(2) from linear regression analyses. Patients who had a poor initial response (VA 20/40 or worse with persistent fluid and without ≥1-line VA gain) were defined as candidates for changing treatment. MAIN OUTCOME MEASURES: Visual acuity change from baseline. RESULTS: Statistically significant (P < 0.05) baseline predictors for less VA gain at year 2 were older age, VA of 20/40 or better, larger choroidal neovascularization area, presence of geographic atrophy, total foveal thickness ≤325 μm or ≥425 μm, and elevation of retinal pigment epithelium. Among 176 eyes gaining ≥3 lines at week 12, 78% had a ≥3-line gain at year 2, whereas among 113 eyes losing ≥1 line at week 12, 27% improved to a ≥1-line gain at year 2. Visual acuity response at week 12 was more predictive of VA response at year 2 (R(2) = 0.30) than VA response at week 4 (R(2) = 0.17) and baseline predictors (R(2) = 0.13; P < 0.0001). Among 126 candidates for changing treatment drug at week 12, mean VA improved by 2.8 letters (P = 0.050), mean total retinal thickness decreased 53 μm (P < 0.0001), and fluid resolved in 33% (P < 0.0001) between week 12 and year 1 with continued use of the same drug and regimen. Similar improvements were observed among 83 candidates for changing drugs at week 24. CONCLUSIONS:Visual acuity response at week 12 is more predictive of 2-year vision outcomes than either several baseline characteristics or week 4 response. Eyes with poor initial response may benefit from continued treatment without switching to another drug.
RCT Entities:
PURPOSE: To evaluate the association of baseline characteristics and early visual acuity (VA) response with visual outcomes at years 1 or 2 in the Comparison of Age-Related Macular Degeneration (AMD) Treatments Trials (CATT). DESIGN: Secondary analysis of CATT. PARTICIPANTS: The 1185 CATT participants with baseline VA of 20/25 to 20/320. METHODS:Participants were assigned to ranibizumab or bevacizumab and to 1 of 3 dosing regimens. Associations of baseline characteristics and early VA response (week 4 or 12) with VA response at years 1 or 2 were assessed by R(2) from linear regression analyses. Patients who had a poor initial response (VA 20/40 or worse with persistent fluid and without ≥1-line VA gain) were defined as candidates for changing treatment. MAIN OUTCOME MEASURES: Visual acuity change from baseline. RESULTS: Statistically significant (P < 0.05) baseline predictors for less VA gain at year 2 were older age, VA of 20/40 or better, larger choroidal neovascularization area, presence of geographic atrophy, total foveal thickness ≤325 μm or ≥425 μm, and elevation of retinal pigment epithelium. Among 176 eyes gaining ≥3 lines at week 12, 78% had a ≥3-line gain at year 2, whereas among 113 eyes losing ≥1 line at week 12, 27% improved to a ≥1-line gain at year 2. Visual acuity response at week 12 was more predictive of VA response at year 2 (R(2) = 0.30) than VA response at week 4 (R(2) = 0.17) and baseline predictors (R(2) = 0.13; P < 0.0001). Among 126 candidates for changing treatment drug at week 12, mean VA improved by 2.8 letters (P = 0.050), mean total retinal thickness decreased 53 μm (P < 0.0001), and fluid resolved in 33% (P < 0.0001) between week 12 and year 1 with continued use of the same drug and regimen. Similar improvements were observed among 83 candidates for changing drugs at week 24. CONCLUSIONS: Visual acuity response at week 12 is more predictive of 2-year vision outcomes than either several baseline characteristics or week 4 response. Eyes with poor initial response may benefit from continued treatment without switching to another drug.
Authors: Francis Char DeCroos; Cynthia A Toth; Sandra S Stinnett; Cynthia S Heydary; Russell Burns; Glenn J Jaffe Journal: Ophthalmology Date: 2012-08-28 Impact factor: 12.079
Authors: Juan E Grunwald; Ebenezer Daniel; Gui-Shuang Ying; Maxwell Pistilli; Maureen G Maguire; Judith Alexander; Revell Whittock-Martin; Candace R Parker; Krista Sepielli; Barbara A Blodi; Daniel F Martin Journal: Ophthalmology Date: 2012-04-17 Impact factor: 12.079
Authors: Gui-shuang Ying; Jiayan Huang; Maureen G Maguire; Glenn J Jaffe; Juan E Grunwald; Cynthia Toth; Ebenezer Daniel; Michael Klein; Dante Pieramici; John Wells; Daniel F Martin Journal: Ophthalmology Date: 2012-10-06 Impact factor: 12.079
Authors: Benjamin Bakall; James C Folk; H Culver Boldt; Elliott H Sohn; Edwin M Stone; Stephen R Russell; Vinit B Mahajan Journal: Am J Ophthalmol Date: 2013-05-22 Impact factor: 5.258
Authors: Stephanie A Hagstrom; Gui-Shuang Ying; Gayle J T Pauer; Gwen M Sturgill-Short; Jiayan Huang; David G Callanan; Ivana K Kim; Michael L Klein; Maureen G Maguire; Daniel F Martin Journal: Ophthalmology Date: 2013-01-18 Impact factor: 12.079
Authors: Brandon G Busbee; Allen C Ho; David M Brown; Jeffrey S Heier; Ivan J Suñer; Zhengrong Li; Roman G Rubio; Phillip Lai Journal: Ophthalmology Date: 2013-01-23 Impact factor: 12.079
Authors: Yoshihiro Yonekawa; Christopher Andreoli; John B Miller; John I Loewenstein; Lucia Sobrin; Dean Eliott; Demetrios G Vavvas; Joan W Miller; Ivana K Kim Journal: Am J Ophthalmol Date: 2013-05-10 Impact factor: 5.258
Authors: Jeffrey S Heier; David M Brown; Victor Chong; Jean-Francois Korobelnik; Peter K Kaiser; Quan Dong Nguyen; Bernd Kirchhof; Allen Ho; Yuichiro Ogura; George D Yancopoulos; Neil Stahl; Robert Vitti; Alyson J Berliner; Yuhwen Soo; Majid Anderesi; Georg Groetzbach; Bernd Sommerauer; Rupert Sandbrink; Christian Simader; Ursula Schmidt-Erfurth Journal: Ophthalmology Date: 2012-10-17 Impact factor: 12.079
Authors: Usha Chakravarthy; Simon P Harding; Chris A Rogers; Susan M Downes; Andrew J Lotery; Sarah Wordsworth; Barnaby C Reeves Journal: Ophthalmology Date: 2012-05-11 Impact factor: 12.079
Authors: Matthew A Windsor; Sissi J J Sun; Kevin D Frick; Eric A Swanson; Philip J Rosenfeld; David Huang Journal: Am J Ophthalmol Date: 2017-12-07 Impact factor: 5.258
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
Authors: Atsuro Uchida; Deepa Manjunath; Rishi P Singh; Aleksandra V Rachitskaya; Peter K Kaiser; Sunil K Srivastava; Jamie L Reese; Justis P Ehlers Journal: Ophthalmol Retina Date: 2018-06-14
Authors: Gui-Shuang Ying; Maureen G Maguire; Wei Pan; Juan E Grunwald; Ebenezer Daniel; Glenn J Jaffe; Cynthia A Toth; Stephanie A Hagstrom; Daniel F Martin Journal: Ophthalmol Retina Date: 2018-06