Combination verteporfin photodynamic therapy ranibizumab-dexamethasone in choroidal neovascularization due to age-related macular degeneration: results of a phase II randomized trial.
OBJECTIVE
To assess whether combination therapy (CT) reduces retreatments when compared to ranibizumab monotherapy (RM), while safely maintaining similar vision outcomes.


METHODS
In this 24-month trial, patients with age-related macular degeneration (AMD) were randomized to 1) quarter-fluence or 2) half-fluence triple therapy (verteporfin photodynamic therapy [vPDT] + ranibizumab + dexamethasone), 3) half-fluence double therapy (vPDT + ranibizumab), or 4) RM. The primary outcomes were number of retreatment visits and change from baseline in visual acuity (VA) at 12 months.


RESULTS
One hundred sixty-two subjects enrolled. There were 4.0 (P=0.02), 3.2 (P<0.001), 4.1 (P=0.03), and 5.7 retreatment visits through month 12, and 5.9 (P=0.03), 4.3 (P<0.001), 5.9 (P=0.02) and 8.7 through month 24, in groups 1, 2, 3, and 4, respectively (P-value comparing with RM). Month 12 VA score change from baseline (95% confidence interval) was +3.6 (-0.9 to +8.1), +6.8 (+2.4 to +11.1), +5.0 (+0.6 to +9.3), and +6.5 (+1.7 to +11.4), respectively.


CONCLUSIONS
CT resulted in significantly fewer retreatment visits than a RM regimen at months 12 and 24. VA results appeared similar although wide confidence intervals preclude conclusions regarding vision outcomes.
Retina Macula Institute, Torrance, CA.
Ron P
RP
Gallemore
Retina Macula Institute, Torrance, CA.
Josh
J
Wallsh
Retina Centers PC, Tucson, AZ.
Henry L
HL
Hudson
Wills Eye Institute, Philadelphia, PA.
Allen C
AC
Ho
Eyesight Ophthalmic Services, Portsmouth, NH.
Richard
R
Chace
Retinal Consultants Medical Group, Sacramento, CA, USA.
Joel
J
Pearlman
age-related macular degeneration (AMD); combination therapy; photodynamic therapy (PDT); ranibizumab; verteporfin