Anecortave acetate (15 milligrams) versus photodynamic therapy for treatment of subfoveal neovascularization in age-related macular degeneration.
OBJECTIVE
To compare 1-year safety and efficacy of anecortave acetate 15 mg with photodynamic therapy (PDT) with verteporfin in patients eligible for initial PDT treatment.


METHODS
Prospective, masked, randomized, multicenter, parallel group, active control, noninferiority clinical trial.


METHODS
Five hundred thirty patients with predominantly classic subfoveal choroidal neovascularization secondary to age-related macular degeneration were randomized to treatment with either anecortave acetate 15 mg or PDT.


METHODS
In the anecortave acetate group, the drug was administered under the Tenon's capsule as a periocular posterior juxtascleral depot (PJD) at the beginning of the study and at month 6. Before the first administration of anecortave acetate, patients in this treatment group received a sham PDT treatment, and sham PDT treatments were repeated every 3 months if there was evidence of leakage on fluorescein angiography (FA). Patients assigned to PDT received up to 4 PDT treatments at 3-month intervals, as needed based upon FA, and a sham PJD procedure at the beginning of the study and at month 6. Best-corrected visual acuity was determined at baseline and all follow-up visits. Safety data were regularly reviewed by an independent safety committee.


METHODS
Percent responders (patients losing <3 lines of vision) at month 12.


RESULTS
Percent responders in the anecortave acetate and PDT groups were 45% and 49%, respectively (not statistically different, P = 0.43). The confidence interval (CI) for the difference ranged from -13.2% favoring PDT to +5.6% favoring anecortave acetate. The month 12 clinical outcome for anecortave acetate was improved in patients for whom reflux was controlled and who were treated within the 6-month treatment window (57% vs. 49%; 95% CI, -4.3% favoring PDT to +21.7% favoring anecortave acetate). No serious adverse events related to the study drug were reported in either treatment group.


CONCLUSIONS
The safety and efficacy outcomes in this study demonstrate that the benefits of anecortave acetate for the treatment of choroidal neovascularization outweigh the risks associated with either the drug or the PJD administration procedure.
Slakter
Jason S
JS
Vitreous-Retina-Macula Consultants of New York, New York, New York, USA.
Bochow
Thomas W
TW
D'Amico
Donald J
DJ
Marks
Bethany
B
Jerdan
Janice
J
Sullivan
E Kenneth
EK
Robertson
Stella M
SM
Slakter
Jason S
JS
Sullins
Greg
G
Zilliox
Patricia
P
D000368:Aged; D000369:Aged, 80 and over; D020533:Angiogenesis Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D020256:Choroidal Neovascularization / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D003238:Connective Tissue / Q000187:drug effects; D004311:Double-Blind Method; D005260:Female; D005451:Fluorescein Angiography; D005584:Fovea Centralis; D006801:Humans; D008268:Macular Degeneration / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D010778:Photochemotherapy; D017319:Photosensitizing Agents / Q000009:adverse effects / Q000627:therapeutic use*; D011166:Porphyrins / Q000009:adverse effects / Q000627:therapeutic use; D011244:Pregnadienediols / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D016896:Treatment Outcome; D000077362:Verteporfin; D014792:Visual Acuity / Q000502:physiology
D020533:Angiogenesis Inhibitors; D017319:Photosensitizing Agents; D011166:Porphyrins; D011244:Pregnadienediols; D000077362:Verteporfin; C418047:anecortave acetate