Sustained Benefits from Ranibizumab for Macular Edema Following Branch Retinal Vein Occlusion: 12-Month Outcomes of a Phase III Study

Retinal Consultants of Houston, Houston, Texas, USA.
Ophthalmology (Impact Factor: 6.14). 06/2011; 118(8):1594-602. DOI: 10.1016/j.ophtha.2011.02.022
Source: PubMed


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.

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    • "Ranibizumab is a humanized anti-VEGF antibody that inhibits all forms of biologically active VEGF [24]. Treatment with ranibizumab appears to significantly decrease bleeding and exudation in neovascular age-related macular degeneration [25], polypoidal choroidal vasculopathy [26], and retinal vein occlusion [27]. Ranibizumab has several theoretical advantages over bevacizumab. "
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    ABSTRACT: Purpose To evaluate the efficacy of anti-vascular endothelial growth factor (VEGF) compared with observation for treating acute central serous chorioretinopathy (CSC). Methods A retrospective study of 36 patients with acute CSC, including 21 patients treated with anti-VEGF (anti-VEGF group) and 15 patients with observation (observation group). Patients in the anti-VEGF group received a single dose of bevacizumab or ranibizumab at baseline. Best-corrected visual acuity (BCVA), central foveal thickness (CFT) and resolution of subretinal fluid (SRF) on optical coherence tomography (OCT) were assessed. The integrity of the foveal inner segment/outer segment (IS/OS) line at 12 months was also analyzed. Results Resolution of SRF was achieved in 20 of 21 eyes in the anti-VEGF group and in 12 of 15 eyes in the observation group (p = 0.151). Mean BCVA and CFT were not different between the two groups at 12 months (p > 0.05). The amount of change in BCVA, however, differed significantly between the groups (p = 0.044). Final OCT more frequently detected the foveal IS/OS line in the anti-VEGF group than in the observation group (p = 0.012). Conclusions In terms of BCVA, anti-VEGF and observation only had similar therapeutic effects in acute CSC patients. In some patients, however, the rapid resolution of SRF by anti-VEGF might reduce the risk of photoreceptor degeneration and improve long-term visual acuity.
    Full-text · Article · Aug 2014 · Korean Journal of Ophthalmology
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    • "Results from open-label extension studies to BRAVO, CRUISE and GENEVA (not included in this review as they were not RCTs) have been reported and provide further data on the efficacy and safety of ranibizumab up to 24 months and dexamethasone IVT up to 12 months [52-55]; in the extensions to BRAVO and CRUISE, all patients received ranibizumab 0.5 mg on an as-needed basis. These studies reported that improvements in BCVA following 6 months of treatment with ranibizumab were maintained up to 24 months in patients with BRVO [52,55] and up to 12 months in patients with CRVO, followed by a slight loss in BCVA between months 12 and 24 [53,55]. "
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    ABSTRACT: Macular oedema secondary to retinal vein occlusion (RVO) can cause vision loss due to blockage of the central retinal vein (CRVO) or a branch retinal vein (BRVO). This systematic review assessed the efficacies of widely used treatments for macular oedema secondary to RVO and the feasibility of conducting indirect comparisons between these therapies. A systematic review was undertaken in November 2010, including a literature search for trials in medical databases and relevant websites. Abstracts, conference presentations and unpublished studies were considered. Studies were data-extracted and quality assessed by two independent researchers. Outcome measures included the mean change in best corrected visual acuity (BCVA) from baseline in the study eye and/or number of patients gaining at least 10 letters from baseline to 6 months or the nearest equivalent time point. Fourteen unique randomized controlled trials (RCTs) were identified. Ranibizumab 0.5 mg produced greater improvements in BCVA at 6 months than sham in BRVO (mean difference 11.0 letters, 95% confidence interval [CI] 7.83, 14.17) and CRVO (mean difference 14.10 letters, 95% CI 10.51, 17.69) in two double-blind sham-controlled RCTs. Pooled data from two double-blind, sham-controlled RCTs showed that improvements in BCVA were also significantly better for dexamethasone intravitreal (IVT) implant 0.7 mg compared with sham in patients with BRVO or CRVO (mean difference 2.5 letters, 95% CI 0.7, 4.3); the difference was significant for BRVO alone, but not CRVO alone. A significantly greater proportion of patients with BRVO gained >=15 letters with laser therapy vs. no treatment at 36 months in a large prospective RCT (odds ratio 3.16, 95% CI 1.25, 8.00), whereas no difference was observed at 9 months in a smaller study. Three studies reported no benefit for laser therapy in CRVO. No indirect comparisons with ranibizumab were feasible due to differences in study design and baseline characteristics. Data from RCTs for ranibizumab and dexamethasone IVT demonstrate that both new agents constitute significant improvements over the previously widely accepted standard of care (laser therapy) for the treatment of BRVO and CRVO. However, head-to-head studies are needed to assess the relative efficacies of licensed therapies for RVO.
    Full-text · Article · Jan 2014 · BMC Ophthalmology
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    • "In the BRAVO trial,7 8 rescue grid laser photocoagulation was offered once during the 6-month treatment period and once during the 6-month observation period for patients meeting the treatment criteria. At month 12 in the BRAVO study,8 56.0% of patients in the 0.3 mg group and 60.3% of patients in the 0.5 mg group gained 15 ETDRS letters or more. In contrast, 20% of patients in the grid laser arm of the SCORE study2 gained 15 letters of VA at month 12 without concomitant anti-VEGF therapy. "
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    ABSTRACT: To determine the 2-year outcomes of intravitreal bevacizumab (IVB) injections in eyes with macular oedema (ME) following branch retinal vein occlusion (BRVO). 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. 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). 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.
    Full-text · Article · Nov 2013 · The British journal of ophthalmology
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