Dosing regimen and the frequency of macular hemorrhages in neovascular age-related macular degeneration treated with ranibizumab.
OBJECTIVE
The purpose of this study was to investigate if monthly intravitreal ranibizumab decreases risk of macular hemorrhages in patients with choroidal neovascularization secondary to age-related macular degeneration.


METHODS
Incidences of macular hemorrhages in the control and ranibizumab groups from three, multicenter, randomized, clinical trials (MARINA, ANCHOR, and PIER) were compared. Two time intervals (Months 0-3 and 5-17) were evaluated to account for transition from monthly to quarterly injections in PIER. Time interval after Month 17 was excluded because of crossover from control to active treatment in all trials.


RESULTS
Months 0-3: All trials showed higher incidence rates of hemorrhages in control compared with ranibizumab groups (ANCHOR: photodynamic therapy [27.3%], 0.3 mg [8.0%], 0.5 mg [8.6%]; MARINA: sham [18.6%], 0.3 mg [8.8%], 0.5 mg [8.8%]; and PIER: sham [16.1%], 0.3 mg [3.4%], 0.5 mg [3.3%]). In ANCHOR and MARINA, data of Months 5-17 showed higher incidence rates in control compared with monthly ranibizumab groups (ANCHOR: photodynamic therapy [47.8%], 0.3 mg [12.5%], 0.5 mg [12.3%]; and MARINA: sham [38.0%], 0.3 mg [13.2%], 0.5 mg [13.0%]), but this was not seen for quarterly ranibizumab groups in PIER (sham [22.4%], 0.3 mg [23.7%], 0.5 mg [28.3%]).


CONCLUSIONS
Treatment with monthly intravitreal ranibizumab was associated with reduced risk of new macular hemorrhages when compared with photodynamic therapy (ANCHOR) or sham (MARINA and PIER). There was no difference between PIER quarterly ranibizumab-treated and sham patients.
Barbazetto
Irene
I
Vitreous Retina Macula Consultants of New York, New York 10022, USA.
Saroj
Namrata
N
Shapiro
Howard
H
Wong
Pamela
P
Freund
K Bailey
KB
D020533:Angiogenesis Inhibitors / Q000008:administration & dosage*; D000911:Antibodies, Monoclonal / Q000008:administration & dosage*; D061067:Antibodies, Monoclonal, Humanized; D000925:Anticoagulants / Q000008:administration & dosage; D020256:Choroidal Neovascularization / Q000188:drug therapy* / Q000209:etiology; D004311:Double-Blind Method; D005451:Fluorescein Angiography; D006801:Humans; D015994:Incidence; D007429:Intraocular Pressure / Q000502:physiology; D058449:Intravitreal Injections; D008268:Macular Degeneration / Q000150:complications / Q000188:drug therapy*; D009887:Ophthalmoscopy; D010778:Photochemotherapy; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage; D000069579:Ranibizumab; D012166:Retinal Hemorrhage / Q000209:etiology / Q000517:prevention & control*; D041623:Tomography, Optical Coherence; D042461:Vascular Endothelial Growth Factor A / Q000037:antagonists & inhibitors; D014792:Visual Acuity / Q000502:physiology
D020533:Angiogenesis Inhibitors; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000925:Anticoagulants; D010975:Platelet Aggregation Inhibitors; C467484:VEGFA protein, human; D042461:Vascular Endothelial Growth Factor A; D000069579:Ranibizumab