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Differences in the characteristics of subjects achieving complete, partial, or no resolution of macular edema in the READ-3 study

  • Retinal Disorders
  • Published:
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Abstract

Purpose

To identify baseline characteristics of subjects enrolled in the READ-3 study that would predict the response of macular edema to ranibizumab (RBZ) therapy at year 1.

Methods

In this post hoc analysis of the READ-3 randomized, multicenter phase 2 clinical trial, subjects with diabetic macular edema (DME) were randomized to receive monthly intravitreal injections of RBZ (0.5 or 2.0 mg) for 6 consecutive injections followed by as-needed treatments based on pre-defined retreatment criteria. In this sub-study, subjects were divided into three groups (persistent, rebound, and resolved) based on edema status at month 12 (M12). Multi-logistic regression was utilized to assess the probability of edema outcomes M12, based on the baseline characteristics.

Results

One hundred twenty-three out of 152 subjects were analyzed for this sub-study. A significant difference was observed in the baseline (BL) central subfield thickness (CST) among the study groups (p < 0.05). BL CST was a significant predictor for edema outcome at M12 with > 80% probability of the subject having persistent edema if BL CST was > 570 μm (p < 0.05). This association persisted when controlled for the dose of RBZ (relative risk (RR), 1.007; p < 0.05). BL CST was also a significant predictor for having persistent edema at M12 in subjects without vitreomacular adhesion (VMA) (> 80% probability of edema persistence at CST > 570 μm [RR, 1.006; p < 0.05]). However, in the presence of VMA, BL CST was no longer a significant predictor of having persistent edema at month 12 (RR, 1.005; p > 0.05).

Conclusions

Subjects with high CST (> 570 μm) at baseline may not benefit from repeated intravitreal injections of anti-VEGF for resolution of edema.

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Authors and Affiliations

  1. Byers Eye Institute, Stanford University, 2370 Watson Court – Suite 200, Palo Alto, CA, 94303, USA

    Muhammad Sohail Halim, Rubbia Afridi, Murat Hasanreisoglu, Muhammad Hassan, Diana V. Do & Yasir Jamal Sepah

  2. Ocular Imaging Research and Reading Center, Menlo Park, CA, USA

    Muhammad Sohail Halim & Mohamed Ibrahim-Ahmed

  3. Department of Ophthalmology, Koç University, School of Medicine, Istanbul, Turkey

    Murat Hasanreisoglu

  4. Koç University Research Center for Translational Medicine, Istanbul, Turkey

    Murat Hasanreisoglu

Authors
  1. Muhammad Sohail Halim
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  2. Rubbia Afridi
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  3. Murat Hasanreisoglu
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  4. Muhammad Hassan
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  6. Diana V. Do
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for the READ-3 Investigators

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Correspondence to Yasir Jamal Sepah.

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All procedures performed in studies involving human participants were in accordance with the 1964 Helsinki declaration and approved by a local investigational review board for some sites and by the Western Institutional Review Board for others.

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Halim, M.S., Afridi, R., Hasanreisoglu, M. et al. Differences in the characteristics of subjects achieving complete, partial, or no resolution of macular edema in the READ-3 study. Graefes Arch Clin Exp Ophthalmol 259, 2941–2948 (2021). https://doi.org/10.1007/s00417-021-05148-6

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  • DOI: https://doi.org/10.1007/s00417-021-05148-6

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