Verteporfin therapy of subfoveal choroidal neovascularization in pathologic myopia: 2-year results of a randomized clinical trial--VIP report no. 3.
OBJECTIVE
To report 24-month vision and fluorescein angiographic outcomes from trials evaluating photodynamic therapy with verteporfin in patients with subfoveal choroidal neovascularization (CNV) caused by pathologic myopia.


METHODS
Multicenter, double-masked, placebo-controlled, randomized clinical trial at 28 ophthalmology practices in Europe and North America.


METHODS
Patients with subfoveal choroidal neovascular lesions caused by pathologic myopia measuring no more than 5400 micro m and best-corrected visual acuity (approximate Snellen equivalent) of 20/100 or better.


METHODS
Similar to methods described for 1-year results with follow-up examinations beyond 1 year, continuing every 3 months (except Photograph Reading Center evaluations only at the month 24 examination). During the second year, the same regimen (with verteporfin or placebo as applied at baseline) was used if angiography showed fluorescein leakage from CNV.


METHODS
The primary outcome was the proportion of eyes with fewer than 8 letters (approximately 1.5 lines) of visual acuity loss at the month 24 examination, adhering to an intent-to-treat analysis and using the last observation carried forward method to impute for any missing data.


RESULTS
Seventy-seven of 81 patients (95%) in the verteporfin group, compared with 36 of 39 patients (92%) in the placebo group, completed the month 24 examination. At this time point, 29 of 81 verteporfin-treated patients (36%) compared with 20 of 39 placebo-treated patients (51%) lost at least 8 letters (P = 0.11). The distribution of change in visual acuity at the month 24 examination was in favor of a benefit for the cases assigned to verteporfin (P = 0.05). This included improvement by at least 5 letters (equivalent to at least 1 line) in 32 verteporfin-treated cases [40%] vs. five placebo-treated cases (13%) and improvement by at least 15 letters (equivalent to at least 3 lines) in 10 verteporfin-treated cases (12%) vs. zero placebo-treated cases. No additional photosensitivity adverse reactions or injection site adverse events were associated with verteporfin therapy in the second year of follow-up.


CONCLUSIONS
Verteporfin therapy for subfoveal CNV caused by pathologic myopia safely maintained a visual benefit compared with a placebo therapy through 2 years of follow-up. Although the primary outcome was not statistically significantly in favor of verteporfin therapy at 2 years as it had been at 1 year of follow-up, the distribution of change in visual acuity at the month 24 examination was in favor of the verteporfin-treated group and showed that this group was more likely to have improved visual acuity through the month 24 examination. The VIP Study Group recommends verteporfin therapy for subfoveal CNV resulting from pathologic myopia based on both the 1- and 2-year results of this randomized clinical trial.
Blinder
Kevin J
KJ
Blumenkranz
Mark S
MS
Bressler
Neil M
NM
Bressler
Susan B
SB
Donato
Guy
G
Lewis
Hilel
H
Lim
Jennifer I
JI
Menchini
Ugo
U
Miller
Joan W
JW
Mones
Jordi M
JM
Potter
Michael J
MJ
Pournaras
Constantin
C
Reaves
Al
A
Rosenfeld
Philip
P
Schachat
Andrew P
AP
Schmidt-Erfurth
Ursula
U
Sickenberg
Michel
M
Singerman
Lawrence J
LJ
Slakter
Jason S
JS
Strong
H Andrew
HA
Virgili
Gianni
G
Williams
George A
GA
D000328:Adult; D000368:Aged; D020256:Choroidal Neovascularization / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology; D004311:Double-Blind Method; D005260:Female; D005451:Fluorescein Angiography; D005500:Follow-Up Studies; D005584:Fovea Centralis; D006801:Humans; D008297:Male; D008875:Middle Aged; D009216:Myopia / Q000150:complications* / Q000473:pathology; D010778:Photochemotherapy; D017319:Photosensitizing Agents / Q000627:therapeutic use*; D011166:Porphyrins / Q000627:therapeutic use*; D011446:Prospective Studies; D012449:Safety; D016896:Treatment Outcome; D000077362:Verteporfin; D014792:Visual Acuity
D017319:Photosensitizing Agents; D011166:Porphyrins; D000077362:Verteporfin