June 2017
Volume 58, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2017
Ranibizumab efficacy in nAMD using a treat and extend regimen: a comparison between the interventional TREND and non-interventional LUMINOUS studies
Author Affiliations & Notes
  • Paul Mitchell
    Ophthalmology, University of Sydney, North Sydney, New South Wales, Australia
  • Wayne Macfadden
    Novartis Pharma AG, Basel, Switzerland
  • Volker Möckel
    Novartis Pharma AG, Basel, Switzerland
  • Sue Lacey
    Novartis Pharma AG, Basel, Switzerland
  • Cornelia Dunger-Baldauf
    Novartis Pharma AG, Basel, Switzerland
  • Footnotes
    Commercial Relationships   Paul Mitchell, Allergen (C), Allergen (R), Bayer (C), Bayer (R), Genentech (C), Genentech (R), Novartis (C), Novartis (R), Roche (C), Roche (R); Wayne Macfadden, Novartis Pharma AG (E); Volker Möckel, Novartis Pharma AG (E); Sue Lacey, Novartis Pharma AG (E); Cornelia Dunger-Baldauf, Novartis Pharma AG (E)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science June 2017, Vol.58, 891. doi:
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      Paul Mitchell, Wayne Macfadden, Volker Möckel, Sue Lacey, Cornelia Dunger-Baldauf; Ranibizumab efficacy in nAMD using a treat and extend regimen: a comparison between the interventional TREND and non-interventional LUMINOUS studies. Invest. Ophthalmol. Vis. Sci. 2017;58(8):891.

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

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Abstract

Purpose : Randomized clinical trials are the gold standard research method for unproven treatments; however, restrictive inclusion/exclusion criteria can limit the generalizability of findings to everyday clinical practice. We compare ranibizumab efficacy in neovascular age related macular degeneration (nAMD) using a treat and extend (T&E) regimen from a clinical trial with real-world evidence from a similar cohort within the non-interventional LUMINOUS study.

Methods : TREND, a recent one-year, visual acuity (VA) assessor-masked, interventional clinical trial, compared the efficacy and safety of T&E dosing of 0.5 mg ranibizumab intravitreal injections with monthly dosing in newly diagnosed, treatment-naïve nAMD patients.
LUMINOUS, a global, 5-year, multicenter, observational study across all approved ranibizumab indications, evaluated long-term safety and effectiveness of ranibizumab 0.5 mg in routine clinical practice.
We compared one-year efficacy and safety outcomes between patients who received T&E dosing in the TREND study (N=323) and a cohort of treatment-naïve patients with nAMD from Australian sites within the LUMINOUS study (N=227; Year 3 interim analysis), which predominantly received ranibizumab according to a T&E approach.

Results : Baseline patient demographics were generally well balanced (Table 1), although LUMINOUS patients had lower mean VA and older age. Mean VA gains after 12 months were 6.6 and 5.3 Early Treatment Diabetic Retinopathy Study (ETDRS) letters, with an average 8.7 and 7.9 ranibizumab injections, in the TREND and LUMINOUS cohorts, respectively (Figure 1). Good vision (≥73 letters, VA 20/40) was achieved by 45.0% and 32.3% of patients, respectively. The rate of ocular serious adverse events (SAEs) was 1.2% and 0.4%, while non-ocular SAEs was 11.1% and 4.3%, respectively. No new safety signals were identified.

Conclusions : Treatment-naïve nAMD patients from the Australian cohort of the real-world LUMINOUS study achieved comparable treatment outcomes to patients in the T&E arm of the TREND clinical trial, despite the lack of strict enrollment criteria. This replication of clinical trial VA improvement with ranibizumab in the real world confirms the generalizability of the TREND clinical trial results.

This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.

 

Table 1. Baseline demographics and ocular characteristics

Table 1. Baseline demographics and ocular characteristics

 

Figure 1. Visual acuity over 1 year in treatment-naïve patients with nAMD

Figure 1. Visual acuity over 1 year in treatment-naïve patients with nAMD

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