Abstract | PURPOSE: DESIGN: Prospective, masked, randomized, multicenter, parallel group, active control, noninferiority clinical trial. PARTICIPANTS: 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. MAIN OUTCOME MEASURE: 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:
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Authors | Jason S Slakter, Thomas W Bochow, Donald J D'Amico, Bethany Marks, Janice Jerdan, E Kenneth Sullivan, Stella M Robertson, Jason S Slakter, Greg Sullins, Patricia Zilliox, Anecortave Acetate Clinical Study Group |
Journal | Ophthalmology
(Ophthalmology)
Vol. 113
Issue 1
Pg. 3-13
(Jan 2006)
ISSN: 1549-4713 [Electronic] United States |
PMID | 16368146
(Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
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Chemical References |
- Angiogenesis Inhibitors
- Photosensitizing Agents
- Porphyrins
- Pregnadienediols
- Verteporfin
- anecortave acetate
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Topics |
- Aged
- Aged, 80 and over
- Angiogenesis Inhibitors
(administration & dosage, adverse effects)
- Choroidal Neovascularization
(drug therapy, etiology, physiopathology)
- Connective Tissue
(drug effects)
- Double-Blind Method
- Female
- Fluorescein Angiography
- Fovea Centralis
- Humans
- Macular Degeneration
(complications, drug therapy, physiopathology)
- Male
- Middle Aged
- Photochemotherapy
- Photosensitizing Agents
(adverse effects, therapeutic use)
- Porphyrins
(adverse effects, therapeutic use)
- Pregnadienediols
(administration & dosage, adverse effects)
- Prospective Studies
- Treatment Outcome
- Verteporfin
- Visual Acuity
(physiology)
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