EVEREST study report 2: imaging and grading protocol, and baseline characteristics of a randomised controlled trial of polypoidal choroidal vasculopathy

Br J Ophthalmol. 2015 May;99(5):624-8. doi: 10.1136/bjophthalmol-2014-305674. Epub 2015 Mar 10.

Abstract

Purpose: To describe the imaging standards, grading protocol and baseline characteristics of polypoidal choroidal vasculopathy (PCV) from the EVEREST study.

Methods: In a prospective, multicentre study, confocal scanning laser ophthalmoscope indocyanine green angiography (ICGA) was performed using a standardised imaging protocol. All images were graded using standardised, calibrated equipment by fellowship-trained ophthalmologists at the Central Reading Center.

Results: Sixty-one patients with PCV were included in the study. ICGA characteristics included: nodular appearance stereoscopically (56 eyes, 91.8%), hypofluorescent halo (42, 68.9%), abnormal vascular network (54, 88.5%) and pulsation of the polyps (4, 6.6%). Colour fundus photography revealed orange subretinal nodules (34, 55.7%) and massive submacular haemorrhage (8, 13.1%). The mean area of the PCV lesion was 3.11 mm(2) (range, 0.2-10.7 mm(2)). The vascular channels filled within 7.3-32.0 s (mean: 17.9 s) while the mean filling time for polyps was 21.9 s (range, 7.3-40.4 s). Patients with massive submacular haemorrhage were less likely to have abnormal vascular channels seen on ICGA (28.6% vs 83.3% for those without massive haemorrhage, p=0.001).

Conclusions: The imaging and grading protocols and baseline characteristics of a multicentre, randomised controlled trial of PCV are described in detail, and may serve as reference for future randomised, controlled trials on PCV.

Clinical trial number: This work was supported by Novartis Pharma AG, Basel, Switzerland grant number NCT00674323 (clinicaltrials.gov).

Keywords: Choroid; Macula; Neovascularisation; Retina.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Choroid / blood supply
  • Choroidal Neovascularization / classification
  • Choroidal Neovascularization / diagnosis*
  • Coloring Agents
  • Female
  • Fluorescein Angiography*
  • Humans
  • Indocyanine Green
  • Male
  • Microscopy, Confocal
  • Middle Aged
  • Ophthalmoscopy*
  • Polyps / classification
  • Polyps / diagnosis*
  • Prospective Studies

Substances

  • Coloring Agents
  • Indocyanine Green

Associated data

  • ClinicalTrials.gov/NCT00674323