A randomised prospective double-masked exploratory study comparing combination
photodynamic treatment and intravitreal ranibizumab vs intravitreal ranibizumab
monotherapy in the treatment of neovascular age-related macular degeneration.
Author(s): Vallance JH, Johnson B, Majid MA, Banerjee S, Mandal K, Bailey CC.
Affiliation(s): Clinical Research Unit, Bristol Eye Hospital, Bristol, UK.
Publication date & source: 2010, Eye (Lond). , 24(10):1561-7
AIMS: The aim of this study is to evaluate the effect of standard-fluence
verteporfin photodynamic therapy (PDT) delivered on the first day of a
ranibizumab regimen for choroidal neovascularisation secondary to age-related
macular degeneration compared with ranibizumab monotherapy.
METHODS: Patients were randomised to sham or standard-fluence verteporfin PDT at
baseline. The first of three monthly loading doses of ranibizumab was given on
the same day, and thereafter patients received monthly treatment with ranibizumab
as required. All patients underwent monthly visual acuity and OCT assessment and
3-monthly fluorescein angiography with follow-up to 1 year.
RESULTS: In all, 18 patients were recruited. The PDT group gained a mean of 2.2
ETDRS letters at 1 year and the sham group gained a mean of 4.4 letters (P=0.47).
Both groups required a mean of 1.3 injections of ranibizumab following the
3-month loading phase. Fluorescein angiography at 1 month demonstrated marked
choroidal hypoperfusion in all patients treated with PDT with reduced choroidal
perfusion persisting to month 12. This did not occur in the sham group.
CONCLUSION: The addition of standard-fluence verteporfin PDT at baseline to a
ranibizumab regimen conferred no benefit in terms of visual acuity or number of
ranibizumab injections required at 1 year. The combination of these treatments
resulted in persistent reduced choroidal perfusion, which raises potential safety
concerns.
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