First Author: S.Dodhia UK
Co Author(s): S. Mann
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Following the BRAVO study (ranibizumab for macular oedema secondary to BRVO), intravitreal ranibizumab (an anti-VEGF-A agent) injections are now considered first line therapy for patients with cystoid macular oedema secondary to branch retina vein occlusion. In the UK, according to NICE guidance (TA 283), this treatment is recommended for those not suitable for or who have not responded to laser treatment. The purpose of this audit is to determine the 12 month efficacy of intravitreal ranibizumab injections in BRVO and to compare results to treatment with a dexamethasone implant (700µg) which was previously used in the department.
This audit was carried out at a single site teaching hospital in a major City in the UK.
Patients with CMO secondary to BRVO started on a course of 0.5mg ranibizumab with 1 year follow up were ascertained from the departmental electronic database. Data were obtained retrospectively by reviewing electronic patient records, patient notes, and optical coherence tomography (OCT) scans. Data regarding age at diagnosis, gender, visual acuity (VA), central retinal thickness (CRT), intraocular pressure (IOP), dates of intravitreal treatment, and the total number of treatments over 1 year were recorded. Data concerning CRT and VA were obtained from three occasions: the date of first ranibizumab treatment, at 6 months and 12 months after treatment initiation. Visual acuity was calculated as an equivalent EDTRS letter score before data analysis was performed. CRT data from the central 3mm from the OCT scans were recorded. Of these 5 sectors, the sector with the greatest thickness value on the date of first Lucentis treatment was identified. Data analysis was performed using subsequent thickness values in this selected sector. Initial analysis of complete data from 22 patients has been performed.
Initial analysis of data collected from 22 patients (22 eyes) was performed. There were 10 female and 12 male patients, with a mean age of 68, ages ranged from 46 to 91. The mean decrease in CRT was 143.8μm observed at 6 months and a mean decrease of 161.8μm at 12 months from the date of initial treatment. One patient had an increase in CRT of 168μm at 6 months (406μm to 574μm) and a further patient had an increase of CRT of 12μm at 1 year (416μm to 428μm). The average gain in VA at 6 months after initial treatment was 12 EDTRS letters and a VA improvement of at least 15 EDTRS letters occurred in 45.5% of the 22 eyes. This compared favourably with only 31% patients treated with a dexamethasone implant gaining 15 EDTRS letters at 6 months (reported previously). At 12 months an average gain of 10.9 EDTRS letters was observed. No patient developed visually significant cataract requiring surgery.
Our results show a good response to ranibizumab for the treatment of macular oedema secondary to BRVO in terms of VA and CRT. The average gain of 12 EDTRS letters at 6 months is less than the average gain of 18.3 EDTRS letters reported in the BRAVO trial but our data represents the real world and our patients received 3 loading injections followed by a PRN regime (pro re nata) rather than monthly injections as in the trial. The percentage of patients achieving a gain of at least 15 ETDRS letters at 6 months is 45.5% which although less than the 61.1% of patients reported in the BRAVO trial, is superior to the 31% reported previously in our department receiving treatment with a dexamethasone implant (Ozurdex®). We recognise that the small sample size is a limitation of our study but allows us to identify an improvement in CRT and VA. We are continuing to collect data to further validate our results. The outcomes compare favourably to those patients treated with Ozurdex® within our department with a higher proportion of patients achieving a gain of 15 ETDRS letters at 6 months. This may be related to fewer patients developing cataract.