July 2018
Volume 59, Issue 9
ARVO Annual Meeting Abstract  |   July 2018
Screening failure rates in the EVEREST II clinical trial: challenges in the diagnosis of symptomatic macular polypoidal choroidal vasculopathy
Author Affiliations & Notes
  • Colin S Tan
    Ophthalmology, National Healthcare Group Eye Institute, Singapore, Singapore
  • Soumil Parikh
    Novartis Pharma AG, Basel, Switzerland
  • Footnotes
    Commercial Relationships   Colin Tan, Bayer (F), Heidelberg Engineering (F), Novartis (F); Soumil Parikh, Novartis (E)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science July 2018, Vol.59, 2404. doi:
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      Colin S Tan, Soumil Parikh; Screening failure rates in the EVEREST II clinical trial: challenges in the diagnosis of symptomatic macular polypoidal choroidal vasculopathy
      . Invest. Ophthalmol. Vis. Sci. 2018;59(9):2404.

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

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Purpose : To assess the ocular pathology of patients who were initially diagnosed as polypoidal choroidal vasculopathy (PCV) by EVEREST II study investigators but subsequently excluded from the trial following Central Reading Center (CRC) evaluation.

Methods : EVEREST II was a 24-month, phase IV, randomized, double-masked, multicenter study that compared the efficacy and safety of combination therapy of ranibizumab 0.5 mg and verteporfin photodynamic therapy with ranibizumab monotherapy in PCV. The presence of PCV in one study eye and eligibility for enrollment were confirmed by the CRC (Fundus Image Reading Centre, Singapore) using a standardized reading protocol as defined by the presence of active macular polypoidal lesions on indocyanine green angiography and serosanguineous maculopathy on fundus photography and fluorescein angiography.

Results : Overall, 491 participants were screened by the CRC of which 169 (34.4%) were deemed screening failures. Misdiagnosis of PCV in patients with typical neovascular age-related macular degeneration (nAMD) was the primary reason for screening failures, accounting for 53.7% of the cases assessed. The second most prominent category for screening failures was confirmed PCV diagnosis but unsuitable for recruitment (28.4%), in which the predominant subgroups were PCV disease activity not involving the macula (48.6%), concurrent pathology (31.4%), and PDT size in excess of study limits of 5400 µm (20.0%). In addition, a smaller number of screening failures were due to misdiagnosis of dry AMD (8.1%), central serous chorioretinopathy (4.1%), retinal angiomatous proliferation (2.4%), equivocal lesions (0.8%), and retinal microaneurysms (0.8%).

Conclusions : The employment of well-defined, stringent criteria by the CRC during screening of participants in EVEREST II ensured that only definite PCV cases were recruited. The relatively high screening failure rate is indicative of the challenges in PCV diagnosis, owing to its clinical and angiographic resemblance to other retinal pathologies. The primary reason for exclusion following CRC screening was PCV diagnosis in patients whose pathology was nAMD. Correct diagnosis of PCV is important to ensure appropriate therapy.

This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.


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