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Verteporfin plus ranibizumab for choroidal neovascularization in age-related macular degeneration: twelve-month MONT BLANC study results.
Ophthalmology 2012; 119(5):992-1000O

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+Show Affiliations

Department of Ophthalmology, Glostrup Hospital, University of Copenhagen, Glostrup, Denmark. miclar01@glo.regionh.dkNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase II
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

22424834

Citation

Larsen, Michael, et al. "Verteporfin Plus Ranibizumab for Choroidal Neovascularization in Age-related Macular Degeneration: Twelve-month MONT BLANC Study Results." Ophthalmology, vol. 119, no. 5, 2012, pp. 992-1000.
Larsen M, Schmidt-Erfurth U, Lanzetta P, et al. Verteporfin plus ranibizumab for choroidal neovascularization in age-related macular degeneration: twelve-month MONT BLANC study results. Ophthalmology. 2012;119(5):992-1000.
Larsen, M., Schmidt-Erfurth, U., Lanzetta, P., Wolf, S., Simader, C., Tokaji, E., ... Weisberger, A. (2012). Verteporfin plus ranibizumab for choroidal neovascularization in age-related macular degeneration: twelve-month MONT BLANC study results. Ophthalmology, 119(5), pp. 992-1000. doi:10.1016/j.ophtha.2012.02.002.
Larsen M, et al. Verteporfin Plus Ranibizumab for Choroidal Neovascularization in Age-related Macular Degeneration: Twelve-month MONT BLANC Study Results. Ophthalmology. 2012;119(5):992-1000. PubMed PMID: 22424834.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Verteporfin plus ranibizumab for choroidal neovascularization in age-related macular degeneration: twelve-month MONT BLANC study results. AU - Larsen,Michael, AU - Schmidt-Erfurth,Ursula, AU - Lanzetta,Paolo, AU - Wolf,Sebastian, AU - Simader,Christian, AU - Tokaji,Erika, AU - Pilz,Stefan, AU - Weisberger,Annemarie, AU - ,, Y1 - 2012/03/17/ PY - 2011/06/27/received PY - 2012/02/01/revised PY - 2012/02/01/accepted PY - 2012/3/20/entrez PY - 2012/3/20/pubmed PY - 2012/6/29/medline SP - 992 EP - 1000 JF - Ophthalmology JO - Ophthalmology VL - 119 IS - 5 N2 - 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. SN - 1549-4713 UR - https://www.unboundmedicine.com/medline/citation/22424834/Verteporfin_plus_ranibizumab_for_choroidal_neovascularization_in_age_related_macular_degeneration:_twelve_month_MONT_BLANC_study_results_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0161-6420(12)00122-4 DB - PRIME DP - Unbound Medicine ER -