June 2017
Volume 58, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2017
Real life experience of combined fixed-dosing and Treat and Extend protocols for the treatment of Diabetic Macular Oedema (DMO) with Anti-Vascular Endothelial Growth Factors (VEGF) agents
Author Affiliations & Notes
  • Karim El-Assal
    Sunderland Eye Infirmary, Sunderland, United Kingdom
  • Alex Stubbing-Moore
    Sunderland Eye Infirmary, Sunderland, United Kingdom
  • Caspar Geenen
    Sunderland Eye Infirmary, Sunderland, United Kingdom
  • Deepali Varma
    Sunderland Eye Infirmary, Sunderland, United Kingdom
  • Ajay Kumar Kotagiri
    Sunderland Eye Infirmary, Sunderland, United Kingdom
  • Jonathan Smith
    Sunderland Eye Infirmary, Sunderland, United Kingdom
  • David H W Steel
    Sunderland Eye Infirmary, Sunderland, United Kingdom
  • Maged S Habib
    Sunderland Eye Infirmary, Sunderland, United Kingdom
  • Footnotes
    Commercial Relationships   Karim El-Assal, None; Alex Stubbing-Moore, None; Caspar Geenen, None; Deepali Varma, None; Ajay Kumar Kotagiri, None; Jonathan Smith, None; David Steel, None; Maged Habib, None
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science June 2017, Vol.58, 1899. doi:
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      Karim El-Assal, Alex Stubbing-Moore, Caspar Geenen, Deepali Varma, Ajay Kumar Kotagiri, Jonathan Smith, David H W Steel, Maged S Habib; Real life experience of combined fixed-dosing and Treat and Extend protocols for the treatment of Diabetic Macular Oedema (DMO) with Anti-Vascular Endothelial Growth Factors (VEGF) agents. Invest. Ophthalmol. Vis. Sci. 2017;58(8):1899.

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

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Abstract

Purpose : Clinical trials have shown the benefit of Anti-VEGF agents in treating centrally involved DMO (CI DMO). Several protocols have been adopted such as Pro re nata (PRN), Treat and Extend (T&E), and Fixed Dosing (FD). Real life data have however failed to replicate trials’ outcomes. Our results from previous audit for DMO patients showed that PRN protocol following initial loading dose of Anti-VEFG agents failed to maintain initial best corrected visual acuity (BCVA) gains over 12 months. In this audit, we evaluated the functional and structural outcome of a modified mixed protocol of FD with T&E following initial loading doses in patients with CI DMO.

Methods : Retrospective data collection for treatment-naive patients with CI DMO, initiated with Anti-VEGF agents between March 2015 and March 2016.
All patients received 5 initial monthly loading doses, followed by fixed 2-monthly injections for the first year. In second year, unstable patients (Loss of BCVA more than 5 letters from baseline and/or 15% increase of baseline central macular thickness (CMT)) received batch of 3 injections on 4 – 6 weekly intervals and then reassessed, while stable patients (BCVA less than 5 letters loss and/or less than 15% increase in CMT) are scheduled for batches of 2 injections on 2-monthly basis. Resolved patients (BCVA more than 5 letters gain and dry macula) are extended to 3-monthly injections and monitored thereafter.

Results : 57 eyes of 52 patients were included. Mean age 65.2 years (SD 11.7), 68% were males. 70% were treated with Ranibizumab while 30% received Aflibercept injections. Baseline BCVA was 65.9 letters (SD 12.6), while baseline CMT was 422.6 (SD 71.1). At month 6 following loading dose, BCVA improved to 70.2 letters (SD 11.8)
At 12 months, mean BCVA was maintained at 71.5 letters (SD 11.5) with CMT of 318 (SD 75.9) with an average of 7.3 injections in the first year. BCVA was maintained at 75.6 letters for 13 patients completing 18 months follow up (21%).

Conclusions : Our results demonstrate that in clinical practice, initial BCVA gains can be maintained at one year and beyond by adopting a modified mixed FD and T&E approach, in contrast to our previous results with PRN protocols. The new protocols have the benefit of timely delivering of predetermined scheduled treatments and reducing the burden on clinic capacity.

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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