Abstract
Purpose :
To evaluate whether re-treatment with intravitreal application of ranibizumab given by the first observation of intraretinal fluid detected by optical coherence tomography (OCT) improves the final best corrected visual acuity (BCVA) at month 12 when compared with re-treatment given by presence of significant macular edema with decrease of BCVA
Methods :
In total 18 treatment naive BRVO patients were included into the prospective interventional Trial ("Ranibizumab given by OCT") and randomized into two group. Both groups received 3 initial monthly ranibizumab injections. Furthre re-treatment was guided by OCT findings. The experimental group received re-applications by first presence of intraretinal fluid even the BCVA remained stable. In the control group the re-injections were given when the recurrence of macular edema with decrease of BCVA ≥5 ETDRS letters. Changes in BCVA in ETDRS letters, central retinal thickness (CRT), number of applied ranibizumab injections and rates of adverse events (AEs and SAEs) were documented over 12 months and compared between the study arms.
Results :
TThe BCVA improved in experimental group at last visit (EoS=End of Study) compared to baseline in mean 4.3 (SD± 6.1) ETDRS letters and in the control group in mean 6.8 (SD± 10.6) ETDRS letters. The difference between both groups was not significant (-2,44 letters; (95%CI:-11.06;6.17) letters; p=0.556). Here, a rather smaller heterogeneity was observed with higher BCVA score within the experimental group. Only minor group difference was observed regarding the CRT between groups during the course of trial (the change at EoS visit compared to baseline was in the experimental arm CRT -42.2µm (SD± 76.9µm) compared to control group with -80.8µm (SD± 164.4µm). The patients in experimental group received in mean 9.2 (SD± 2.9) and the controls 6.8 (SD± 3.2) ranibizumab applications. No relevant AEs and SAEs were observed in both study arms during the entire trial.
Conclusions :
The immediate re-injection by the first presence of intraretinal fluid did not significantly improve the finale functional results of ranibizumab treatment in patients with BRVO. A larger trial with longer follow-up is necessary to investigate the impact of intensified anti-VEGF treatment on macular morphology and long-time functional results.
This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.