An optical coherence tomography-guided, variable dosing regimen with intravitreal ranibizumab (Lucentis) for neovascular age-related macular degeneration.
OBJECTIVE
To evaluate an optical coherence tomography (OCT)-guided, variable-dosing regimen with intravitreal ranibizumab for the treatment of patients with neovascular age-related macular degeneration (AMD).


METHODS
Open-label, prospective, single-center, nonrandomized, investigator-sponsored clinical study.


METHODS
In this two-year study, neovascular AMD patients with subfoveal choroidal neovascularization (CNV) (n = 40) and a central retinal thickness of at least 300 microm as measured by OCT were enrolled to receive three consecutive monthly intravitreal injections of ranibizumab (0.5 mg). Thereafter, retreatment with ranibizumab was performed if one of the following changes was observed between visits: a loss of five letters in conjunction with fluid in the macula as detected by OCT, an increase in OCT central retinal thickness of at least 100 microm, new-onset classic CNV, new macular hemorrhage, or persistent macular fluid detected by OCT at least one month after the previous injection of ranibizumab.


RESULTS
At month 12, the mean visual acuity improved by 9.3 letters (P < .001) and the mean OCT central retinal thickness decreased by 178 microm (P < .001). Visual acuity improved 15 or more letters in 35% of patients. These visual acuity and OCT outcomes were achieved with an average of 5.6 injections over 12 months. After a fluid-free macula was achieved, the mean injection-free interval was 4.5 months before another reinjection was necessary.


CONCLUSIONS
This OCT-guided, variable-dosing regimen with ranibizumab resulted in visual acuity outcomes similar to the Phase III clinical studies, but required fewer intravitreal injections. OCT appears useful for determining when retreatment with ranibizumab is necessary.
Fung
Anne E
AE
Pacific Eye Associates, California Pacific Medical Center, San Francisco, California, USA.
Lalwani
Geeta A
GA
Rosenfeld
Philip J
PJ
Dubovy
Sander R
SR
Michels
Stephan
S
Feuer
William J
WJ
Puliafito
Carmen A
CA
Davis
Janet L
JL
Flynn
Harry W
HW
Esquiabro
Maria
M
D000368:Aged; D000369:Aged, 80 and over; D020533:Angiogenesis Inhibitors / Q000008:administration & dosage*; D000911:Antibodies, Monoclonal / Q000008:administration & dosage*; D061067:Antibodies, Monoclonal, Humanized; D020256:Choroidal Neovascularization / Q000175:diagnosis / Q000188:drug therapy*; D005260:Female; D005451:Fluorescein Angiography; D006801:Humans; D007267:Injections; D008268:Macular Degeneration / Q000175:diagnosis / Q000188:drug therapy*; D008297:Male; D011446:Prospective Studies; D000069579:Ranibizumab; D019233:Retreatment; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D014792:Visual Acuity; D014822:Vitreous Body
D020533:Angiogenesis Inhibitors; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000069579:Ranibizumab