Abstract
Purpose :
This study seeks to compare dexamethasone implant with rescue intravitreal ranibizumab to monthly intravitreal ranibizumab for the treatment of macular edema secondary to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO).
Methods :
The study was a randomized control trial of treatment-naïve patients with BRVO or CRVO and macular edema. Subjects were randomized 1:1 for treatment with dexamethasone implant every 3 months with monthly rescue ranibizumab vs monthly ranibizumab alone. As a pilot study 10 subjects were included in each arm. Visual acuity, intraocular pressure and spectral-domain optical coherence tomography measures of macular edema were measured at baseline and monthly visits for 6 months.
Results :
Eight of 10 patients in the study arm and 8 of 10 patients in the control arm completed the study. Each group consisted of 5 patients with BRVO and 5 patients with CRVO. Baseline visual acuity and central macular thickness were comparable between the two groups. At the 6-month final endpoint, there was no statistically significant difference in improvement of visual acuity between the two groups (12 letters vs 16 letters; p = 0.608). There was no statistically significant difference in improvement in central macular thickness between the two groups (385 vs 370 microns; p =0.866). However, total number of injections was less in the treatment group (4.5 vs 5.75 injections; p < 0.05). There were no systemic adverse events, however, two patients in the dexamethasone implant group developed elevated intraocular pressure which returned to baseline with treatment and one patient in the dexamethasone implant group developed a corneal ulcer.
Conclusions :
In this small pilot study, dexamethasone implant with rescue ranibizumab and monthly ranibizumab injections had comparable improvement visual acuity and macular edema. The mean number of injections was significantly lower in the dexamethasone arm. Larger scale trials are needed to determine which treatment methods provide optimal visual outcomes with the best safety profile and least burden on patients and providers.
This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.