title: Effect of lesion size, visual acuity, and lesion composition on visual acuity change with and without verteporfin therapy for choroidal neovascularization secondary to age-related macular degeneration: TAP and VIP report no. 1.
abstract: OBJECTIVE
  To determine whether differences in baseline lesion size and visual acuity might explain differing results found in three different lesion compositions (predominantly classic, minimally classic, and occult with no classic) among three placebo-controlled, randomized clinical trials evaluating photodynamic therapy with verteporfin (Visudyne, Novartis AG), also termed verteporfin therapy, in patients with subfoveal choroidal neovascularization (CNV) due to age-related macular degeneration (AMD).
  
  
  METHODS
  Exploratory analyses were conducted in patients with predominantly classic or minimally classic lesions at enrollment in the Treatment of AMD with Photodynamic Therapy (TAP) Investigation and in AMD patients with occult with no classic CNV in the Verteporfin In Photodynamic Therapy (VIP) Trial. Baseline characteristics of patients among these three lesion compositions were compared. In addition, multiple linear regression modeling was used to explore the effect of baseline lesion size, visual acuity, and lesion composition on mean change in visual acuity from baseline to 24 months.
  
  
  RESULTS
  At baseline, the mean size of predominantly classic lesions (3.4 disk areas) was smaller than that of minimally classic (4.7 disk areas) and occult with no classic lesions (4.3 disk areas). In the multiple linear regression model of individual lesion compositions, there was a significant treatment-by-lesion-size interaction for minimally classic and occult with no classic lesions, but not for predominantly classic lesions. Interaction between treatment and baseline visual acuity was not significant for any lesion composition. Small verteporfin-treated lesions lost less vision than large verteporfin-treated lesions in each lesion composition. In the multiple linear regression model that included all lesion compositions, lesion size was a more significant predictive factor for the magnitude of treatment benefit than either lesion composition or visual acuity. Smaller (4.0 disk areas or less) minimally classic and occult with no classic lesions had similar visual acuity outcomes to those observed in predominantly classic lesions.
  
  
  CONCLUSIONS
  Based on exploratory analyses, lesion size in the TAP Investigation and VIP Trial was an important predictor of the magnitude of treatment benefit with verteporfin therapy in occult with no classic and minimally classic lesion compositions. In patients with AMD, treating smaller rather than larger neovascular lesions, regardless of lesion composition, likely will result in a better level of visual acuity.
authors.affiliation: nmboffice@jhmi.edu
authors.forename: Keven J
authors.initials: KJ
authors.lastname: Blinder
authors.forename: Shannon
authors.initials: S
authors.lastname: Bradley
authors.forename: Neil M
authors.initials: NM
authors.lastname: Bressler
authors.forename: Susan B
authors.initials: SB
authors.lastname: Bressler
authors.forename: Guy
authors.initials: G
authors.lastname: Donati
authors.forename: Yong
authors.initials: Y
authors.lastname: Hao
authors.forename: Colin
authors.initials: C
authors.lastname: Ma
authors.forename: Ugo
authors.initials: U
authors.lastname: Menchini
authors.forename: Joan
authors.initials: J
authors.lastname: Miller
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Potter
authors.forename: Constantin
authors.initials: C
authors.lastname: Pournaras
authors.forename: Al
authors.initials: A
authors.lastname: Reaves
authors.forename: Philip J
authors.initials: PJ
authors.lastname: Rosenfeld
authors.forename: H Andrew
authors.initials: HA
authors.lastname: Strong
authors.forename: Michael
authors.initials: M
authors.lastname: Stur
authors.forename: Xiang Yao
authors.initials: XY
authors.lastname: Su
authors.forename: Gianni
authors.initials: G
authors.lastname: Virgili
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D020256:Choroidal Neovascularization / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology*; D005260:Female; D006801:Humans; D008268:Macular Degeneration / Q000150:complications*; D008297:Male; D008875:Middle Aged; D010778:Photochemotherapy; D017319:Photosensitizing Agents / Q000627:therapeutic use*; D011166:Porphyrins / Q000627:therapeutic use*; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic; D016896:Treatment Outcome; D000077362:Verteporfin; D014792:Visual Acuity / Q000502:physiology*
chemical_list: D017319:Photosensitizing Agents; D011166:Porphyrins; D000077362:Verteporfin