Two-year outcomes of intravitreal bevacizumab therapy for macular oedema secondary to branch retinal vein occlusion

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Abstract

Aim

To determine the 2-year outcomes of intravitreal bevacizumab (IVB) injections in eyes with macular oedema (ME) following branch retinal vein occlusion (BRVO).

Methods

Of 105 consecutive eyes (105 treatment-naïve patients) with ME following BRVO, 89 eyes were followed for 2 years after the first injection. During the 2-year follow-up period, patients were examined at least every 3 months and received an IVB injection (1.25 mg/0.05 mL) if they met prespecified retreatment criteria. Rescue grid laser was permitted based on the findings of the Branch Vein Occlusion Study.

Results

The baseline logarithm of the minimum angle of resolution visual acuity (VA) was 0.64±0.24 (mean±SD), which significantly (p=0.001) improved 1 month after the first injection to 0.39±0.22. One year after the first injection, VA improved significantly (p=0.001) to 0.33±0.21 and remained 0.34±0.21 until 2 years after the first injection (p=0.001). The changes in foveal thickness were correlated with those of VA during the 2-year follow-up period with a mean of 3.8±1.5 injections (including the first injection).

Conclusions

This relatively large case series study showed favourable 2-year outcomes using bevacizumab to treat ME following BRVO. Bevacizumab provides substantial long-term benefits in the treatment of ME following BRVO.

Related collections

Most cited references 18

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Photocoagulation for diabetic macular edema. Early Treatment Diabetic Retinopathy Study report number 1. Early Treatment Diabetic Retinopathy Study research group.

(1985)

Data from the Early Treatment Diabetic Retinopathy Study (ETDRS) show that focal photocoagulation of "clinically significant" diabetic macular edema substantially reduces the risk of visual loss. Focal treatment also increases the chance of visual improvement, decreases the frequency of persistent macular edema, and causes only minor visual field losses. In this randomized clinical trial, which was supported by the National Eye Institute, 754 eyes that had macular edema and mild to moderate diabetic retinopathy were randomly assigned to focal argon laser photocoagulation, while 1,490 such eyes were randomly assigned to deferral of photocoagulation. The beneficial effects of treatment demonstrated in this trial suggest that all eyes with clinically significant diabetic macular edema should be considered for focal photocoagulation. Clinically significant macular edema is defined as retinal thickening that involves or threatens the center of the macula (even if visual acuity is not yet reduced) and is assessed by stereo contact lens biomicroscopy or stereo photography. Follow-up of all ETDRS patients continues without other modifications in the study protocol.

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Sustained benefits from ranibizumab for macular edema following branch retinal vein occlusion: 12-month outcomes of a phase III study.

David M Brown, Peter A Campochiaro, Robert Bhisitkul … (2011)

Assess 12-month efficacy and safety of intraocular injections of 0.3 mg or 0.5 mg ranibizumab in patients with macular edema after branch retinal vein occlusion (BRVO). Prospective, randomized, sham injection-controlled, double-masked, multicenter trial. A total of 397 patients with macular edema after BRVO. Eligible patients were randomized 1:1:1 to 6 monthly injections of 0.3 mg or 0.5 mg ranibizumab or sham injections. After 6 months, all patients with study eye best-corrected visual acuity (BCVA) ≤20/40 or central subfield thickness ≥250 μm were to receive ranibizumab. Patients could receive rescue laser treatment once during the treatment period and once during the observation period if criteria were met. The main efficacy outcome reported is mean change from baseline BCVA letter score at month 12. Additional visual and anatomic parameters were assessed. Mean (95% confidence interval) change from baseline BCVA letter score at month 12 was 16.4 (14.5-18.4) and 18.3 (15.8-20.9) in the 0.3 mg and 0.5 mg groups, respectively, and 12.1 (9.6-14.6) in the sham/0.5 mg group (P<0.01, each ranibizumab group vs. sham/0.5 mg). The percentage of patients who gained ≥15 letters from baseline BCVA at month 12 was 56.0% and 60.3% in the 0.3 mg and 0.5 mg groups, respectively, and 43.9% in the sham/0.5 mg group. On average, there was a marked reduction in central foveal thickness (CFT) after the first as-needed injection of 0.5 mg ranibizumab in the sham/0.5 mg group, which was sustained through month 12. No new ocular or nonocular safety events were identified. At month 12, treatment with ranibizumab as needed during months 6-11 maintained, on average, the benefits achieved by 6 monthly ranibizumab injections in patients with macular edema after BRVO, with low rates of ocular and nonocular safety events. In the sham/0.5 mg group, treatment with ranibizumab as needed for 6 months resulted in rapid reduction in CFT to a similar level as that in the 0.3 mg ranibizumab treatment group and an improvement in BCVA, but not to the extent of that in the 2 ranibizumab groups. Intraocular injections of ranibizumab provide an effective treatment for macular edema after BRVO. Proprietary or commercial disclosure may be found after the references. Copyright © 2011 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

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Ranibizumab for macular edema due to retinal vein occlusions: long-term follow-up in the HORIZON trial.

Jeffrey Heier, Peter A Campochiaro, Linda Yau … (2012)

To assess long-term safety and efficacy of intraocular ranibizumab injections in patients with macular edema after retinal vein occlusion (RVO). Open-label extension trial of the 12-month Ranibizumab for the Treatment of Macular Edema following Branch Retinal Vein Occlusion: Evaluation of Efficacy and Safety (BRAVO) and Central Retinal Vein Occlusion Study: Evaluation of Efficacy and Safety (CRUISE) trials. We included 304 patients who completed BRAVO and 304 patients who completed CRUISE. Patients were seen at least every 3 months and given an intraocular injection of 0.5 mg ranibizumab if they met prespecified retreatment criteria. Primary outcomes were incidence and severity of ocular and nonocular adverse events (AEs). Key efficacy outcomes included mean change from baseline best-corrected visual acuity (BCVA) letter score by Early Treatment Diabetic Retinopathy Study protocol and central foveal thickness. In patients who completed month 12, the mean number of injections (excluding month 12 injection) in the sham/0.5-, 0.3/0.5-, and 0.5-mg groups was 2.0, 2.4, and 2.1 (branch RVO) and 2.9, 3.8, and 3.5 (central RVO), respectively. The incidence of study eye ocular serious AEs (SAEs) and SAEs potentially related to systemic vascular endothelial growth factor inhibition across treatment arms was 2% to 9% and 1% to 6%, respectively. The mean change from baseline BCVA letter score at month 12 in branch RVO patients was 0.9 (sham/0.5 mg), -2.3 (0.3/0.5 mg), and -0.7 (0.5 mg), respectively. The mean change from baseline BCVA at month 12 in central RVO patients was -4.2 (sham/0.5 mg), -5.2 (0.3/0.5 mg), and -4.1 (0.5 mg), respectively. No new safety events were identified with long-term use of ranibizumab; rates of SAEs potentially related to treatment were consistent with prior ranibizumab trials. Reduced follow-up and fewer ranibizumab injections in the second year of treatment were associated with a decline in vision in central RVO patients, but vision in branch RVO patients remained stable. Results suggest that during the second year of ranibizumab treatment of RVO patients, follow-up and injections should be individualized and, on average, central RVO patients may require more frequent follow-up than every 3 months. Copyright © 2012 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

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Author and article information

Journal

Journal ID (nlm-ta): Br J Ophthalmol

Journal ID (iso-abbrev): Br J Ophthalmol

Journal ID (hwp): bjophthalmol

Journal ID (publisher-id): bjo

Title: The British Journal of Ophthalmology

Publisher: BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )

ISSN (Print): 0007-1161

ISSN (Electronic): 1468-2079

Publication date (Print): February 2014

Publication date (Electronic): 8 November 2013

Volume: 98

Issue: 2

Pages: 195-199

Affiliations

Department of Ophthalmology, Ohtsuka Eye Hospital , Sapporo, Japan

Author notes

[Correspondence to ] Dr Taiichi Hikichi, Department of Ophthalmology, Ohtsuka Eye Hospital, Kita-16 Nishi-4, Kita-ku, Sapporo 001-0016, Japan; taiichi-hikichi@ 123456hokkaido.med.or.jp

Article

Publisher ID: bjophthalmol-2013-303121

DOI: 10.1136/bjophthalmol-2013-303121

PMC ID: 3913112

PubMed ID: 24215032

SO-VID: 367fde53-f446-4371-9e5a-8dc9b83de887

License:

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 3.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/3.0/