June 2022
Volume 63, Issue 7
Open Access
ARVO Annual Meeting Abstract  |   June 2022
Treat and Extend Protocol Outcomes in Diabetic Macular Edema: A Meta-Analysis
Author Affiliations & Notes
  • Param Bhatter
    University Hospitals, Cleveland, Ohio, United States
  • Abhinav Bheemidi
    Case Western Reserve University, Cleveland, Ohio, United States
    Cleveland Clinic Cole Eye Institute, Cleveland, Ohio, United States
  • Justin Muste
    University Hospitals, Cleveland, Ohio, United States
  • Shirley Wu
    University Hospitals, Cleveland, Ohio, United States
  • Molly Elson
    University Hospitals, Cleveland, Ohio, United States
  • Carolina Carvalho Soares Valentim
    Cleveland Clinic Cole Eye Institute, Cleveland, Ohio, United States
  • Rishi P Singh
    Cleveland Clinic Cole Eye Institute, Cleveland, Ohio, United States
  • Footnotes
    Commercial Relationships   Param Bhatter None; Abhinav Bheemidi None; Justin Muste None; Shirley Wu None; Molly Elson None; Carolina Carvalho Soares Valentim None; Rishi Singh Apellis, Graybug, Code F (Financial Support), Genentech/Roche, Alcon/Novartis, Zeiss, Bausch & Lomb, Regeneron, Code I (Personal Financial Interest)
  • Footnotes
    Support  This study was supported in part by the NIH-NEI P30 Core Grant (IP30EY025585), Unrestricted Grants from The Research to Prevent Blindness, Inc., and Cleveland Eye Bank Foundation awarded to the Cole Eye Institute
Investigative Ophthalmology & Visual Science June 2022, Vol.63, 2500 – F0226. doi:
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    • Get Citation

      Param Bhatter, Abhinav Bheemidi, Justin Muste, Shirley Wu, Molly Elson, Carolina Carvalho Soares Valentim, Rishi P Singh; Treat and Extend Protocol Outcomes in Diabetic Macular Edema: A Meta-Analysis. Invest. Ophthalmol. Vis. Sci. 2022;63(7):2500 – F0226.

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

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Abstract

Purpose : Intravitreal injections of anti- vascular endothelial growth factor (anti-VEGF) agents
are considered the gold standard for treatment for diabetic macular edema (DME). While
monthly and as needed (PRN) injections schemes have been shown to be effective, they
constitute a burden for patients and providers in real world clinical settings. Alternatively, treat
and extend (T&E) dosing can be used titrate the anti-VEGF dosing based on an individual’s
clinical response while minimizing treatment burden. This study aims to pool available data on
change in visual acuity (VA), number of injections, and change in central subfield thickness
(CST) as reported by T&E regimens for DME compared to monthly and PRN regimens.

Methods : PubMed, Science Direct, and EMBASE databases were queried for studies that met
the following criteria: retrospective or prospective design, T&E regimen reported in comparison
to a monthly or PRN regimen for the treatment of DME, and a 12 month follow up period. After
data were extracted, analysis was performed using a random effect model. Publication bias was
examined using a funnel plot and Egger’s linear regression test. An I^2 test was utilized to
determine heterogeneity.

Results : Six total randomized clinical trials were identified. Three studies compared monthly
regimens to T&E. The remainder compared PRN regimens to T&E. Comparing monthly and
T&E regimens, no significant difference was found between average VA improvement (p=0.30),
CST improvement (p=0.28), or number of injections (p=0.20). Comparing PRN and T&E
regimens, no significant difference was found between average VA improvement (p=0.64), CST
improvement (p=0.11), or number of injections (p=0.89).

Conclusions : In terms of VA and CST, T&E regiments were non-inferior to monthly or PRN
regiments. No significant difference in number of injections was detected. These conclusions are
limited by study design and outcome: only six studies, which included conservative T&E
regimens were included. Furthermore, the criteria did not filter for treatment naïve patients.
Future studies need to characterize the long-term reduction of treatment burden in T&E
protocols.

This abstract was presented at the 2022 ARVO Annual Meeting, held in Denver, CO, May 1-4, 2022, and virtually.

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