Japanese age-related macular degeneration trial: 1-year results of photodynamic therapy with verteporfin in Japanese patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration.
OBJECTIVE
To determine the effect and safety of verteporfin therapy (Visudyne) in Japanese age-related macular degeneration (AMD) patients.


METHODS
Open-label, multicenter, prospective, noncontrolled study.


METHODS
The setting was five university hospitals in Japan. The study population was patients at least 50 years old, with best-corrected visual acuity of 20/40 to 20/200 inclusive and fluorescein angiography documenting subfoveal, classic-containing choroidal neovascularization (CNV) secondary to AMD and a lesion of greatest linear dimension <or= 5400 microm. For the intervention, patients received verteporfin intravenously followed by light administration 15 minutes after the infusion start. Additional treatment was given every 3 months through month 9 if leakage from CNV was observed on angiogram. The main outcome measure was percentage of lesions with progression of classic CNV beyond the area of the baseline lesion.


RESULTS
Sixty-four patients were enrolled at five centers, and 61 patients completed the study. The median number of treatments given during the trial was three. At the 12-month examination, 12 patients (19%; 95% confidence interval: 11%-31%) had progression of classic CNV whereas 32 (50%) and 49 (77%) patients had no leakage from classic or occult CNV, respectively. The median visual acuity score (approximate Snellen equivalent) from baseline to month 12 increased from 50.0 (20/100)-56.5 (20/80(+2)) letters. Fourteen patients (22%) had visual disturbances, including two patients (3%) with acute vision decrease considered as serious adverse events and one patient (2%) with infusion-related back pain. No photosensitivity reactions were reported.


CONCLUSIONS
Verteporfin therapy for subfoveal CNV in these Japanese patients appeared to have a similar or better angiographic and vision effect as that observed in Caucasian patients, with the same safety profile, supporting its use in Japanese patients.
D000368:Aged; D000369:Aged, 80 and over; D020256:Choroidal Neovascularization / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D018450:Disease Progression; D005260:Female; D005451:Fluorescein Angiography; D005584:Fovea Centralis; D006801:Humans; D007262:Infusions, Intravenous; D007564:Japan; D008268:Macular Degeneration / Q000150:complications* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D010778:Photochemotherapy; D017319:Photosensitizing Agents / Q000627:therapeutic use*; D011166:Porphyrins / Q000627:therapeutic use*; D011446:Prospective Studies; D012449:Safety; D000077362:Verteporfin; D014792:Visual Acuity
D017319:Photosensitizing Agents; D011166:Porphyrins; D000077362:Verteporfin