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Muhammad Sohail Halim, Rubbia Afridi, Muhammad Hassan, Mohammad Ali Sadiq, Diana V Do, Quan Dong Nguyen, Yasir Jamal Jamal Sepah; Differences in the characteristics of subjects achieving complete or partial resolution of diabetic macular edema in the READ-3 Study. Invest. Ophthalmol. Vis. Sci. 2017;58(8):1916.
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© ARVO (1962-2015); The Authors (2016-present)
To identify baseline (BL) predictors of edema status at month 12 and to recognize subjects with greater potential for response to ranibizumab (RBZ) therapy.
In the READ-3 study, eyes with DME were randomized to receive monthly intravitreal injections of RBZ (0.5 or 2.0 mg). 130 out of 152 study subjects were analyzed for this post-hoc sub-study. 22 patients did not meet the inclusion criteria and were excluded from the analysis. Subjects were divided into three groups (persistent, rebound and resolved) based on edema status at Month 3, 6, 9 and 12. Analyzed characteristics included demographics, prior anti-VEGF therapy, presence of vitreomacular adhesion (VMA), HbA1c, central subfield thickness (CST) and BCVA. Chi2 and ANOVA were used to assess the differences among the study groups. Multi-logistic regression was utilized to assess the probability of edema outcomes based on the baseline (BL) CST, VMA status, levels of IL-6 and IL-8 and prior anti-VEGF therapy.
There was no significant difference between age, gender, race, BMI, smoking status, HbA1c, and BCVA among the study groups at all time points (p>0.05). A significant difference was observed in the BL-CST among the study groups for both RBZ doses (p<0.05) (Table 1). Regression analysis identified BL CST level as a significant predictor for edema outcome with the probability of patient having persistent edema at M12 of >80% at CST of >575µm (p<0.05) (Fig 1). This association persisted even when the model was controlled for the dose of RBZ (RR: 1.006, p < 0.05). BL CST was a significant predictor for having persistent edema at M12 in patients with no history of VMA with >80% probability of edema persistence at CST>560um (RR:1.006; p<0.03). However, in the presence of VMA, BL CST was no longer a significant predictor and the probability of having persistent edema decreased to 60% at CST of 900µm (RR:0.99; p:0.94). Subjects with prior anti-VEGF therapy had an 80% probability of persistent edema at CST of >480µm; however, this regression model was insignificant (RR:1.01; p:0.13).
DME eyes with high CST (>575) at baseline may not achieve complete resolution of edema despite repeated Intravitreal injections of anti-VEGF therapy. Presence VMA reduces while prior anti-VEGF therapy increases the probability of persistent edema.
This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.
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