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A randomized, double masked, controlled study of the efficacy and safety of intravitreal ranibizumab versus bevacizumab in subjects with macular edema secondary to branch retinal vein occlusion

Session Details

Session Title: Vascular Diseases and Diabetic Retinopathy II

Session Date/Time: Friday 12/09/2014 | 11:00-13:00

Paper Time: 12:04

Venue: Boulevard C

First Author: : R.Narayanan INDIA

Co Author(s): :    B.U. Panchal   J. Chhablani   T. Das   S. Jalali   R.K. Pappuru  

Abstract Details

Purpose:

To assess the efficacy and safety of intravitreally (IVT) administered ranibizumab compared to bevacizumab on bestcorrected visual acuity (BCVA) using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol in subjects with macular edema secondary to branch retinal vein occlusion (BRVO).

Setting:

Tertiary Eye Care Center

Methods:

Single center, non-inferiority trial with equal allocation to groups. This trial was registered (CTRI number REF/2012/01/003120). Seventy-five participants with macular edema secondary to BRVO were randomized 1:1 using block randomization with a block size of 6 to receive either IVT injection of ranibizumab or bevacizumab on an as needed basis.The primary outcome was the mean change in visual acuity (VA) at 6 months, with a non-inferiority limit of 5 letters. The other outcomes were the mean changes in central retinal thickness (CRT) and the safety outcomes. All the patients and outcome assessors were masked to the treatment groups. At each visit the participants underwent BCVA using the ETDRS protocol, slit lamp biomicroscopy, intra ocular pressure measurement, indirect ophthalmoscopy and optical coherence tomography. All participants underwent IVT administration of the study drug at baseline and subsequently as per predefined criteria. Patients were evaluated monthly and macular laser was offered as per defined criteria after 3 months.

Results:

Participants were randomized to group A (37) receiving IVT ranibizumab and to group B (38) receiving IVT bevacizumab with a mean age of 53 and 50 years respectively. The mean BCVA at baseline in group A was 52.81 ± 14.41 letters and 56.10 ± 10.01 letters in group B. At the end of 6 months the mean gain in VA was 18 letters (p<0.0001; 95% Confidence Interval [CI], 12.78 to 22.60) in ranibizumab group and 15 letters (p<0.0001; 95% CI, 12.00 to 20.50) in bevacizumab group. The comparison between ranibizumab and bevacizumab was noninferior (ranibizumab minus bevacizumab: 3 letters, p=0.74; 95% CI, -4.99 to 7.99). The mean CRT at baseline was 441.34 ± 116.52μm in group A and 493.85 ± 162.98μm in group B. At the end of 6 months the mean CRT was 265.53 ± 100.56μm in ranibizumab group and 276.71 ± 67.79μm in bevacizumab group. There were 2 serious adverse events (SAE) in ranibizumab group (significant ERM and fracture tibia) and 1 in bevacizumab group (dengue fever).

Conclusions:

At 6 months, ranibizumab and bevacizumab had equivalent effects on visual acuity in patients with macular edema due to BRVO. SAE were very low in both the groups and the differences were not significant.

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