Comparison of early retreatment with the standard regimen in verteporfin therapy of neovascular age-related macular degeneration.
OBJECTIVE
To compare the efficacy and safety of early retreatment with verteporfin therapy with that of approved standard verteporfin therapy in neovascular age-related macular degeneration.


METHODS
Prospective, randomized, multicenter clinical trial.


METHODS
Two hundred three patients with predominantly classic choroidal neovascularization secondary to age-related macular degeneration.


METHODS
Throughout the first 6 months of follow-up, patients received retreatment with verteporfin therapy either every 2 months (group A) or 3 months (group B). From 6 to 12 months, both groups received retreatment at 3-month intervals.


METHODS
The primary outcome of the study was best-corrected mean visual acuity as measured using the Early Treatment Diabetic Retinopathy Study protocol. The secondary outcomes were percentage of patients losing at least 3 lines of vision, percentage of patients gaining at least 1 line of vision, and lesion size based on the greatest linear dimension (GLD) documented by fluorescein angiography, impact of initial lesion size, and retreatment rate as well as safety.


RESULTS
Visual acuity was similar in both groups at baseline with a mean visual acuity of 20/100(-1). During the 12 months of follow-up, mean visual acuity was better in the early retreatment group at all intervals; however, no statistically significant benefit was seen in the overall population at any time (P>0.1). At month 12, mean visual acuity was 20/160(+1) in group A and 20/160(-1) in group B. There was a trend for better outcomes in the early retreatment group with regard to loss of less than 3 lines of vision at 12 months (61% vs. 51.7%). No statistically significant difference was seen with regard to lesion size for either group throughout follow-up with a final GLD of the lesion of 2790 microm (group A) and 2996 microm (group B). However, subgroup analysis indicated a statistically relevant benefit (P< or =0.004) for patients with small lesions (GLD<2000 microm) at baseline receiving early retreatment.


CONCLUSIONS
Early retreatment in 2-month intervals did not show a significant overall benefit at 1 year of follow-up compared with the standard regimen. However, smaller lesions seemed to benefit from early retreatment with verteporfin therapy in contrast to larger lesions.
Michels
Stephan
S
Klinik für Augenheilkunde und Optometrie, Medizinische Universität Wien, Vienna, Austria.
Wachtlin
Joachim
J
Gamulescu
Maria A
MA
Heimann
Heinrich
H
Prünte
Christian
C
Inhoffen
Werner
W
Krebs
Ilse
I
Schmidt-Erfurth
Ursula
U
D000368:Aged; D020256:Choroidal Neovascularization / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology; D005451:Fluorescein Angiography; D005500:Follow-Up Studies; D006801:Humans; D008268:Macular Degeneration / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*; D010778:Photochemotherapy; D017319:Photosensitizing Agents / Q000009:adverse effects / Q000627:therapeutic use*; D011166:Porphyrins / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D019233:Retreatment; D016896:Treatment Outcome; D000077362:Verteporfin; D014792:Visual Acuity / Q000502:physiology
D017319:Photosensitizing Agents; D011166:Porphyrins; D000077362:Verteporfin