Abstract
Purpose: :
The effectiveness of ranibizumab both on retinal function and retinal morphology has already been proven in many multi-center trials. Treatment effects of monthly versus quarterly injections of ranibizumab in the study eye have been investigated in this phase IIIb multi-center, randomized, active-controlled, double-masked ‘Excite’ trial and have already been reported. In this retrospective analysis the effect of ranibizumab on the non study eye was investigated.
Methods: :
353 patients at 54 study sites with diagnosis of subfoveal CNV in the study eye due to AMD were included. Best-corrected visual acuity (BCVA) inclusion criterion was between 20/40 and 20/320 in the study eye. BCVA exclusion criterion was less than 20/200 in both eyes. Patients were randomized 1:1:1 to receive 3 initial monthly injections of ranibizumab followed by quarterly injections of 0.3mg in group A, quarterly injections of 0.5mg in group B, and monthly injections of 0.3mg in group C. For both eyes change of BCVA letter score and mean central retinal thickness (CRT) in microns (µm) measured with optical coherence tomography (OCT) were monthly examined for all patients in all groups.
Results: :
All groups (120 versus 118 versus 115 patients in groups A, B and C) were balanced regarding age, gender, BCVA, CRT and lesion type for both eyes. At month 3 in all groups a statistically significant increase in VA of 7.0 letters in the study eye versus 3 letters in the non study eye occurred, as well as a statistically significant decrease in CRT of 104µm in the study eye versus 25 µm in the non study eye.BCVA both of the study eye (month 3 versus month 12: further gain of 1 letter in the monthly group, loss of 2 letters in the quarterly groups) and of the non study eye remained stable within the next months.CRT remained stable in the study eye when measured one month after treatment (except transient increase at months 4,5,7,8,10 and 11, when no treatment was performed for more than 1 month in the quarterly groups) and had an additional decrease in the non study eye of 10 µm from month 3 to month 9 which was statistically not significant.The maximum change of CRT was 161-0.91*CRT for the study eye and 121-0.68*CRT for the non study eye.
Conclusions: :
Regularly administrations of ranibizumab in eyes with subfoveal CNV secondary to AMD might have a therapeutic effect also in the second eye. This effect was observed both for BCVA and for CRT. Further analyses also including morphologic changes like cysts, subretinal fluid and pigment epithelial detachment have to be performed.
Clinical Trial: :
www.clinicaltrials.gov NCT00275821
Keywords: age-related macular degeneration • choroid: neovascularization • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials