title: Sustained visual acuity loss in the comparison of age-related macular degeneration treatments trials.
abstract: OBJECTIVE
  Although anti-vascular endothelial growth factor treatment of neovascular age-related macular degeneration (AMD) results in improved vision overall, loss of substantial vision can occur. Understanding the processes that lead to loss of vision may lead to preventive strategies.
  
  
  OBJECTIVE
  To determine the incidence, characteristics, causes, and baseline predictors of sustained visual acuity loss after 2 years of treatment with ranibizumab or bevacizumab for neovascular AMD.
  
  
  METHODS
  A cohort study within a randomized clinical trial of participants in the Comparison of Age-Related Macular Degeneration Treatments Trials (CATT).
  
  
  METHODS
  Participants were randomly assigned to treatment with ranibizumab or bevacizumab and to 2 years of monthly or as needed injections or monthly injections for 1 year and as needed injections the following year.
  
  
  METHODS
  Sustained visual acuity loss, defined as loss of 15 or more letters from baseline at weeks 88 and 104.
  
  
  RESULTS
  Among 1030 participants, 61 eyes (5.9%) developed sustained visual acuity loss in 2 years. Within this group, visual acuity decreased gradually over time, with a mean decrease of 2, 19, and 33 letters from baseline at 4 weeks, 1 year, and 2 years, respectively. At 2 years, eyes with sustained visual acuity loss had more scarring (60.0% vs 41.4%, P = .007), more geographic atrophy (GA) (31.6% vs 20.7%, P = .004), larger lesions (16 vs 8 mm2, P < .001), and higher proportions of intraretinal fluid (82.5% vs 51.0%, P < .001), subretinal hyperreflective material (84.5% vs 44.2%, P < .001), retinal thinning (43.3% vs 23.0%, P < .001), and thickening (20.0% vs 12.1%, P < .001). Likely causes of sustained visual acuity loss included foveal scarring (44.3%), pigmentary abnormalities (27.9%), and foveal GA (11.5%). Baseline factors independently associated with a higher incidence of sustained visual acuity loss were the presence of nonfoveal GA (odds ratio [OR],  2.86; 95% CI, 1.35-6.08; P = .006), larger area of choroidal neovascularization (OR for a >4-disc area vs ≤1-disc area, 3.91; 95% CI, 1.70-9.03; P = .007), and bevacizumab treatment (OR,  1.83; 95% CI, 1.07-3.14; P = .03).
  
  
  CONCLUSIONS
  Sustained visual acuity loss was relatively rare in CATT. The development of foveal scar, pigmentary abnormalities, or GA contributed to most of the sustained visual acuity loss. Risk was 3% higher among eyes treated with bevacizumab. Treatment that targeted the prevention of scarring or GA may improve vision outcomes.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT00593450.
authors.affiliation: Department of Ophthalmology, Perelman School of Medicine, University of Pennsylvania, Philadelphia.
authors.forename: Gui-shuang
authors.initials: GS
authors.lastname: Ying
authors.affiliation: Department of Ophthalmology, Perelman School of Medicine, University of Pennsylvania, Philadelphia.
authors.forename: Benjamin J
authors.initials: BJ
authors.lastname: Kim
authors.affiliation: Department of Ophthalmology, Perelman School of Medicine, University of Pennsylvania, Philadelphia.
authors.forename: Maureen G
authors.initials: MG
authors.lastname: Maguire
authors.affiliation: Department of Ophthalmology, Perelman School of Medicine, University of Pennsylvania, Philadelphia.
authors.forename: Jiayan
authors.initials: J
authors.lastname: Huang
authors.affiliation: Department of Ophthalmology, Perelman School of Medicine, University of Pennsylvania, Philadelphia.
authors.forename: Ebenezer
authors.initials: E
authors.lastname: Daniel
authors.affiliation: Duke Eye Center, Duke University Medical Center, Durham, North Carolina.
authors.forename: Glenn J
authors.initials: GJ
authors.lastname: Jaffe
authors.affiliation: Department of Ophthalmology, Perelman School of Medicine, University of Pennsylvania, Philadelphia.
authors.forename: Juan E
authors.initials: JE
authors.lastname: Grunwald
authors.affiliation: Barnes Retina Institute, St Louis, Missouri.
authors.forename: Kevin J
authors.initials: KJ
authors.lastname: Blinder
authors.affiliation: Casey Eye Institute, Oregon Health and Science University, Portland.
authors.forename: Christina J
authors.initials: CJ
authors.lastname: Flaxel
authors.affiliation: Retina-Vitreous Associates Medical Group, Beverly Hills, California.
authors.forename: Firas
authors.initials: F
authors.lastname: Rahhal
authors.affiliation: Wills Eye Retina Service, Wills Eye Hospital, Philadelphia, Pennsylvania.
authors.forename: Carl
authors.initials: C
authors.lastname: Regillo
authors.affiliation: Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio.
authors.forename: Daniel F
authors.initials: DF
authors.lastname: Martin
mesh_terms: D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D000068258:Bevacizumab; D006801:Humans; D015994:Incidence; D008268:Macular Degeneration / Q000188:drug therapy* / Q000503:physiopathology; D008875:Middle Aged; D000069579:Ranibizumab; D014792:Visual Acuity
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000068258:Bevacizumab; D000069579:Ranibizumab