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.
OBJECTIVE
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.


CONCLUSIONS
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.
Vallance
J H
JH
Clinical Research Unit, Bristol Eye Hospital, Bristol, UK.
Johnson
B
B
Majid
M A
MA
Banerjee
S
S
Mandal
K
K
Bailey
C C
CC
D020533:Angiogenesis Inhibitors / Q000008:administration & dosage*; D000911:Antibodies, Monoclonal / Q000008:administration & dosage*; D061067:Antibodies, Monoclonal, Humanized; D020256:Choroidal Neovascularization / Q000188:drug therapy*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005451:Fluorescein Angiography; D006801:Humans; D058449:Intravitreal Injections; D008268:Macular Degeneration / Q000188:drug therapy*; D010778:Photochemotherapy; D017319:Photosensitizing Agents / Q000008:administration & dosage*; D010865:Pilot Projects; D011166:Porphyrins / Q000627:therapeutic use; D011446:Prospective Studies; D000069579:Ranibizumab; D041623:Tomography, Optical Coherence; D000077362:Verteporfin; D014792:Visual Acuity
D020533:Angiogenesis Inhibitors; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D017319:Photosensitizing Agents; D011166:Porphyrins; D000077362:Verteporfin; D000069579:Ranibizumab