July 2019
Volume 60, Issue 9
Open Access
ARVO Annual Meeting Abstract  |   July 2019
Regression of diabetic retinopathy with anti-VEGF treatment: what is learned from a meta-analysis of four pivotal clinical trials
Author Affiliations & Notes
  • Diana V Do
    Byers Eye Institute, Stanford University School of Medicine, Palo Alto, California, United States
  • Quan Dong Nguyen
    Byers Eye Institute, Stanford University School of Medicine, Palo Alto, California, United States
  • Bann-Mo Day
    Genentech, Inc., South San Francisco, California, United States
  • Tatiana Ecoiffier
    Genentech, Inc., South San Francisco, California, United States
  • Ivo Stoilov
    Genentech, Inc., South San Francisco, California, United States
  • Footnotes
    Commercial Relationships   Diana Do, Bayer (C), Genentech, Inc. (F), Genentech, Inc. (C), Regeneron (F), Regeneron (C), Santen (F), Santen (C), Spouse - Bayer (C), Spouse - Genentech (C), Spouse - Genentech, Inc. (F), Spouse - Regeneron (F), Spouse - Regeneron (C), Spouse - Santen (F), Spouse - Santen (C); Quan Nguyen, Bayer (C), Genentech, Inc. (F), Genentech, Inc. (C), Regeneron (F), Regeneron (C), Santen (F), Santen (C); Bann-Mo Day, Genentech, Inc. (E); Tatiana Ecoiffier, Genentech, Inc. (E); Ivo Stoilov, Genentech, Inc. (E), Genentech, Inc. (I)
  • Footnotes
    Support  Support for RIDE/RISE Studies (NCT00473382/NCT00473330) was provided by Genentech, Inc., a member of the Roche Group. Protocol I (NCT00445003) received support from grants EY14231, EY14229, and EY018817; Protocol T (NCT01627249) received support from grants EY14231, EY23207, and EY18817.
Investigative Ophthalmology & Visual Science July 2019, Vol.60, 1732. doi:https://doi.org/
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      Diana V Do, Quan Dong Nguyen, Bann-Mo Day, Tatiana Ecoiffier, Ivo Stoilov; Regression of diabetic retinopathy with anti-VEGF treatment: what is learned from a meta-analysis of four pivotal clinical trials. Invest. Ophthalmol. Vis. Sci. 2019;60(9):1732. doi: https://doi.org/.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : To conduct a meta-analysis of the effects of ranibizumab (RBZ) on reducing diabetic retinopathy (DR) severity in eyes with varying stages of DR, and to investigate how anti-VEGF treatment at earlier stages of DR might decrease the risk of vision-threatening DR (VTDR).

Methods : Meta-analysis of clinical trials involving RBZ in eyes with DR (with diabetic macular edema; DME) included RIDE (NCT00473382)/RISE (NCT00473330) and DRCR Protocols I (NCT00445003) and T (NCT01627249).1-3 This meta-analysis focused on the RBZ (combined 0.3 mg RBZ, 0.5 mg RBZ, 0.5 mg RBZ + prompt laser, and 0.5 mg RBZ + deferred laser) and sham (sham in RIDE/RISE and sham + prompt laser in Protocol I) treatment arms. Patients with prior panretinal photocoagulation at baseline were excluded from this analysis.

Results : A total of 868 RBZ-treated eyes and 439 sham-treated eyes were included in the analysis. Baseline patient characteristics were similar across the RBZ and sham treatment arms, with respective mean (SD) values: age 61.8 (10.2) years and 63.1 (10.2) years; duration of diabetes 16.0 (9.2) and 15.4 (9.5) years; and HbA1c 7.8 (1.6) and 7.7 (1.5). Baseline DR severity scale (DRSS) score distributions were also comparable in the two arms: 40% and 34% of patients in the RBZ and sham arms, respectively, had moderate non-proliferative DR (NPDR; DRSS ≤43), 47% and 52% of patients, respectively, had moderately severe to severe NPDR (DRSS 47-53), and 14% of patients in both groups had above-mild PDR (DRSS ≥60). In the overall population, ≥2-step improvement in DRSS was observed in 43% of RBZ-treated patients at year 2 compared with 9% of sham-treated patients. When patients were stratified by baseline DR severity, the highest rates of DR improvement were observed in the moderately severe to severe NPDR group, with 73% of the RBZ-treated patients showing significant ≥2-step improvement at year 2 (Figure).

Conclusions : In this meta-analysis of 4 pivotal clinical trials of anti-VEGF treatments for DME, RBZ significantly improved DR in patients with moderate-severe NPDR. Treatment of earlier stages of DR with intravitreal VEGF inhibitors should be considered to prevent development of VTDR.

References
1. Nguyen QD et al; RIDE and RISE Research Group. Ophthalmology. 2012; 119(4):789-801.
2. DRCR.net. Ophthalmology. 2010; 117(6):1064-77.
3. DRCR.net. NEJM. 2015; 372:1193-203.

This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.

 

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