An observational retrospective subgroup analysis of verteporfin photodynamic therapy-naive and previously treated patients in the focus trial.
OBJECTIVE
To perform a retrospective post hoc subgroup analysis of the FOCUS trial to assess the visual acuity outcomes and treatment benefits for patients receiving combination therapy who, at the time of enrollment, were naive to verteporfin photodynamic therapy (PDT) or had previously received PDT.


METHODS
In this retrospective post hoc analysis of 24-month data from the FOCUS trial, PDT-naive and previously PDT-treated patients (n = 162) were included. Patients were randomized in a 2:1 ratio to receive 0.5 mg of ranibizumab monthly plus PDT or PDT alone. We retrospectively identified patients who had or had not received prior PDT for a post hoc subgroup analysis of 12- and 24-month outcomes.


RESULTS
For the PDT-naive patients, mean change in the visual acuity at 24 months was +4.1 letters for the ranibizumab plus PDT group and -11.5 letters for the PDT monotherapy group, a treatment benefit over control group of 15.6 letters (95% confidence interval: 7.1-24.2). For the previously treated patients, mean change in the visual acuity at 24 months was +5.2 letters for the ranibizumab plus PDT group and -4.3 letters for the PDT monotherapy group, a treatment benefit over control group of 9.5 letters (95% confidence interval: 2.3-16.8).


CONCLUSIONS
In the FOCUS subanalysis, the PDT-naive patients showed a trend toward greater treatment benefit over control subjects compared with patients previously treated with PDT. However, this study was not designed to address this question, and the confidence intervals were wide. Furthermore, the mean change in the visual acuity from baseline to 24 months was similar for both the PDT-naive and previously treated patients receiving combination therapy.
Apte
Rajendra S
RS
Ophthalmology and Visual Sciences, Washington University School of Medicine, St. Louis, MO, USA. apte@vision.wustl.edu
Alexander
Sherri L
SL
Henry
Erin C
EC
Wong
Pamela
P
Tuomi
Lisa
L
D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage; D061067:Antibodies, Monoclonal, Humanized; D020256:Choroidal Neovascularization / Q000188:drug therapy* / Q000209:etiology* / Q000503:physiopathology; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008268:Macular Degeneration / Q000150:complications* / Q000188:drug therapy / Q000503:physiopathology; D008297:Male; D008499:Medical Records; D008875:Middle Aged; D010778:Photochemotherapy; D017319:Photosensitizing Agents / Q000627:therapeutic use*; D011166:Porphyrins / Q000627:therapeutic use*; D000069579:Ranibizumab; D012189:Retrospective Studies; D016037:Single-Blind Method; D016896:Treatment Outcome; D000077362:Verteporfin; D014792:Visual Acuity / Q000187:drug effects
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D017319:Photosensitizing Agents; D011166:Porphyrins; D000077362:Verteporfin; D000069579:Ranibizumab