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Muhammad Hassan, Mohammad Ali Sadiq, Muhammad Sohail Halim, Rubbia Afridi, Nam V Nguyen, Yasir Jamal Sepah; Short-Term effects of Ranibizumab on Diabetic Retinopathy Severity and Progression in the Ranibizumab for Edema of the Macula in Diabetes – Protocol 3 with High Dose (READ-3) Study.. Invest. Ophthalmol. Vis. Sci. 2018;59(9):1909.
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To evaluate the short-term effects of two doses of Ranibizumab (0.5mg and 2.0mg) on diabetic retinopathy (DR) severity in patients with diabetic macular edema (DME).
In the READ-3 study, patients with DME were stratified into two groups to receive either 0.5mg or 2.0mg monthly intravitreal ranibizumab until month 6, followed by pro-re-nata dosing until month 24. Seven field fundus photographs were evaluated utilizing a 9-step ETDRS diabetic retinopathy (DR) severity scale, to assess DR severity at baseline, month 3 and month 6 by a centralized reading center. Chi-sqaure and logistic regression was utilized to assess differences in proportion of subjects demonstrating change in DR severity at month 3 and month 6.
Out of 152 eyes (152 patients) randomized in the READ-3 study, 91 eyes (91 patients) fulfilled the inclusion criteria for the index study. Thirty-nine eyes in the 0.5mg group and 24 eyes in 2.0mg group with the potential for improvement in the DR severity score were analyzed. Twenty-eight eyes (44.4%; 18 in 0.5mg and 10 in 2.0mg) had a prior history of PRP with baseline DR severity score 60. The median ETDRS DR severity score improved from 4 (moderate NPDR) to 3 (mild NPDR) at month 3 and was maintained at month 6 in both study groups. The proportion of patients with DR severity score of mild or better increased at month 3 (0.5mg:32.4% and 2.0mg:36.4%) and month 6 (0.5mg:41% and 2.0mg:50%) from baseline (0.5mg: 12.8% and 2.0mg: 4.2%) (Figure 1). 22.9% of eyes (groups combined) demonstrated a ≥2-step reduction in the ETDRS DR severity scale (0.5mg: 33.3% and 2.0mg:7.1%), at month 6 (Figure 2). The difference between the groups was not significant (p=0.071). Worsening of the DR severity was not demonstrated by any of the study subjects.
Intravitreal ranibizumab has a role in stopping the progression of DR severity in patient with DME starting as early as 3 to 6 months. 2.0 mg ranibizumab did not demonstrate any additional benefit over 0.5mg ranibizumab in improving DR severity.
This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.
Figure 1. Proportion of Subjects with ETDRS Severity Score of Mild or Better
Figure 2. Percentage of Patients with ≥2 Step Reduction in DR Severity Score
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