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Original Investigation | Clinical Trial

Reading Speed Improvements in Retinal Vein Occlusion After Ranibizumab Treatment

Ivan J. Suñer, MD1; Neil M. Bressler, MD2; Rohit Varma, MD3; Paul Lee, MD4; Chantal M. Dolan, PhD5; James Ward, PhD5; Shoshana Colman, PhD5; Roman G. Rubio, MD5
[+] Author Affiliations
1Retina Associates of Florida, Tampa
2Wilmer Eye Institute, The Johns Hopkins University School of Medicine, Baltimore, Maryland
3Doheny Eye Institute, University of Southern California, Los Angeles
4Duke Eye Center, Duke University School of Medicine, Durham, North Carolina
5Genentech, Inc, South San Francisco, California
JAMA Ophthalmol. 2013;131(7):851-856. doi:10.1001/jamaophthalmol.2013.114.
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Importance  Treatment of macular edema secondary to retinal vein occlusion with ranibizumab has been shown to improve visual acuity compared with macular laser or observation. It is important to determine whether these visual acuity improvements translate into measurable improvements in visual function.

Objective  To examine the benefit of ranibizumab (Lucentis) on measured reading speed, a direct performance assessment, through 6 months in eyes of patients with macular edema after retinal vein occlusion (RVO).

Design  Two multicenter, double-masked, phase 3 trials in which participants with macular edema after branch RVO or central RVO were randomized 1:1:1 to monthly sham, ranibizumab, 0.3 mg, or ranibizumab, 0.5 mg, for 6 months.

Setting  Community- and academic-based ophthalmology practices specializing in retinal diseases.

Participants  Seven hundred eighty-nine eyes of 789 participants who were at least aged 18 years with macular edema secondary to retinal vein occlusion in the branch vein occlusion (BRAVO) and central vein occlusion (CRUISE) trials.

Interventions  Eyes were randomized 1:1:1 to 1 of 3 groups for monthly injections for 6 months: sham (132 in BRAVO and 130 in CRUISE), intravitreal ranibizumab, 0.3 mg (134 in BRAVO and 132 in CRUISE), and intravitreal ranibizumab, 0.5 mg (131 in BRAVO and 130 in CRUISE). Patients were able to receive macular laser after 3 months if they met prespecified criteria.

Main Outcomes and Measures  Reading speed in the study eye was measured with enlarged text (letter size equivalent to approximately 20/1500 at the test distance) at baseline and 1, 3, and 6 months. The number of correctly read words per minute (wpm) was reported. The reading speed test requires a sixth-grade reading level and does not account for literacy or cognitive state.

Results  In patients with branch RVO, the mean gain for the 0.5-mg group was 31.3 wpm compared with 15.0 wpm in sham-treated eyes (difference, 16.3 wpm; P = .007) at 6 months. In patients with central RVO, the mean gain for the 0.5-mg group was 20.5 wpm compared with 8.1 wpm in sham-treated eyes (difference, 12.4 wpm; P = .01) at 6 months. A gain of 15 or more letters of best-corrected visual acuity letter score corresponded to an increase in reading speed of 12.3 wpm and 15.8 wpm in patients with branch and central RVO, respectively.

Conclusions and Relevance  These results suggest that patients with macular edema after RVO treated monthly with ranibizumab are more likely to have improvements in reading speed of the affected eyes through 6 months compared with sham treatment. These results demonstrate the relevance of the treatment benefit to functional visual gain.

Trial Registration  clinicaltrials.gov Identifier: NCT00486018 and NCT00485836

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Figures

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Figure 1.
Mean Change From Baseline in Reading Speed in the Study Eye at 6 Months

P values are from tests of treatment differences using analysis of covariance t tests (stratified) with end-point baseline value as a covariate and baseline visual acuity letter score (≥55, 54 to 35, ≤34) as the stratification variable. Error bars represent 95% CI. Last-observation-carried-forward method was used to impute missing values. BRAVO indicates Ranibizumab for the Treatment of Macular Edema Following Branch Retinal Vein Occlusion: Evaluation of Efficacy and Safety; CRUISE, Ranibizumab for the Treatment of Macular Edema After Central Retinal Vein Occlusion Study: Evaluation of Efficacy and Safety; and wpm, words per minute.

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Figure 2.
Percentage of Patients With Reading Speed Less Than 40 Words per Minute in the Study Eye

Percentage of patients with reading speed less than 40 words per minute (wpm) in the study eye for (A) BRAVO and (B) CRUISE. (Note: Last-observation-carried-forward reading speed was used to impute missing values.) BL indicates baseline; BRAVO, Ranibizumab for the Treatment of Macular Edema Following Branch Retinal Vein Occlusion: Evaluation of Efficacy and Safety; and CRUISE, Ranibizumab for the Treatment of Macular Edema After Central Retinal Vein Occlusion Study: Evaluation of Efficacy and Safety.

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Figure 3.
Percentage of Patients With Reading Speed Greater Than 160 Words per Minute in the Study Eye

Percentage of patients with reading speed greater than 160 words per minute (wpm) in the study eye for (A) BRAVO and (B) CRUISE. (Note: Last-observation-carried-forward reading speed was used to impute missing values.) BL indicates baseline; BRAVO, Ranibizumab for the Treatment of Macular Edema Following Branch Retinal Vein Occlusion: Evaluation of Efficacy and Safety; and CRUISE, Ranibizumab for the Treatment of Macular Edema after Central Retinal Vein Occlusion Study: Evaluation of Efficacy and Safety.

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