Verteporfin plus ranibizumab for choroidal neovascularization in age-related macular degeneration: twelve-month MONT BLANC study results.

Abstract

PURPOSE:

To compare the efficacy and safety of same-day verteporfin photodynamic therapy (PDT) and intravitreal ranibizumab combination treatment versus ranibizumab monotherapy in neovascular age-related macular degeneration.

DESIGN:

Prospective, multicenter, double-masked, randomized, active-controlled trial.

PARTICIPANTS:

We included 255 patients with all types of active subfoveal choroidal neovascularization.

METHODS:

Patients were randomized 1:1 to as-needed (pro re nata; PRN) combination (standard-fluence verteporfin 6 mg/m(2) PDT and ranibizumab 0.5 mg) or PRN ranibizumab monotherapy (sham infusion [5% dextrose] PDT and ranibizumab 0.5 mg). Patients received 3 consecutive monthly injections followed by PRN retreatments based on protocol-specific retreatment criteria.

MAIN OUTCOME MEASURES:

Mean change in best-corrected visual acuity (BCVA) from baseline to month 12, and the proportion of patients with treatment-free interval ≥3 months at any timepoint after month 2.

RESULTS:

The mean change in BCVA at month 12 was +2.5 and +4.4 letters in the combination and monotherapy groups, respectively (P = 0.0048; difference: -1.9 letters [95% confidence interval, -5.76 to 1.86], for having achieved noninferiority with a margin of 7 letters). The proportion of patients with a treatment-free interval of ≥3 months at any timepoint after month 2 was high, but did not show a clinically relevant difference between the treatment groups. Secondary efficacy endpoints included the mean number of ranibizumab retreatments after month 2 (1.9 and 2.2 with combination and monotherapy, respectively [P = 0.1373]). The time to first ranibizumab retreatment after month 2 was delayed by 34 days (about 1 monthly visit) with combination (month 6) versus monotherapy (month 5). At month 12, mean ± standard error central retinal thickness decreased by 115.3±9.04 μm in the combination group and 107.7±11.02 μm in the monotherapy group. The mean number of verteporfin/sham PDT treatments was comparable in the 2 groups (combination, 1.7; monotherapy, 1.9). The safety profiles of the 2 groups were comparable, with a low incidence of ocular serious adverse events.

CONCLUSIONS:

The combination PRN treatment regimen with verteporfin PDT and ranibizumab was effective in achieving BCVA gain comparable with ranibizumab monotherapy; however, the study did not show benefits with respect to reducing the number of ranibizumab retreatment over 12 months. The combination therapy was well tolerated.

• Authors: Michael Larsen, Ursula Schmidt-Erfurth, Paolo Lanzetta, Sebastian Wolf, Christian Simader, Erika Tokaji, Stefan Pilz, Annemarie Weisberger, MONT BLANC Study Group
• Journal: Ophthalmology (Ophthalmology) Vol. 119 Issue 5 Pg. 992-1000 (May 2012) ISSN: 1549-4713 [Electronic] United States
• PMID: 22424834 (Publication Type: Clinical Trial, Phase II, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: Copyright © 2012 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Chemical References

• Angiogenesis Inhibitors
• Antibodies, Monoclonal, Humanized
• Photosensitizing Agents
• Porphyrins
• Verteporfin
• Ranibizumab

Topics

• Aged
• Aged, 80 and over
• Angiogenesis Inhibitors (adverse effects, therapeutic use)
• Antibodies, Monoclonal, Humanized (adverse effects, therapeutic use)
• Choroidal Neovascularization (drug therapy, physiopathology)
• Combined Modality Therapy
• Double-Blind Method
• Female
• Humans
• Incidence
• Macular Degeneration (drug therapy, physiopathology)
• Male
• Middle Aged
• Photochemotherapy
• Photosensitizing Agents (adverse effects, therapeutic use)
• Porphyrins (adverse effects, therapeutic use)
• Prospective Studies
• Ranibizumab
• Treatment Outcome
• Verteporfin
• Visual Acuity (physiology)