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Related Experiment Videos

Core outcomes for geographic atrophy trials.

Aniela Krystyna Krezel1,2, Ruth Hogg1,2, Lynne Lohfeld2,3

  • 1Centre for Experimental Medicine, Queen's University Belfast, Belfast, UK.

The British Journal of Ophthalmology
|December 19, 2019
PubMed
Summary

This study established a core outcome set (COS) for geographic atrophy (GA) clinical trials. The COS includes patient-reported outcomes, visual acuity, reading speed, and outer retina health for better trial design.

Keywords:
clinical trialmacularetinatreatment medicaltreatment other

Related Experiment Videos

Area of Science:

  • Ophthalmology
  • Clinical Trials
  • Patient-Reported Outcomes

Background:

  • Geographic atrophy (GA) clinical trials currently use varied outcome measures.
  • A standardized Core Outcome Set (COS) is needed for consistent trial design and interpretation.

Purpose of the Study:

  • To identify and propose a COS for GA clinical trials.
  • To ensure outcomes are relevant to patients, clinicians, and researchers.

Main Methods:

  • A five-component project involving Delphi method with patients and experts.
  • Focus groups and interviews with patients, family members, and support workers.
  • Two rounds of Delphi exercise with 301 and 76 participants, respectively; parallel Delphi with 43-21 experts; interviews with 20 patients, 4 family members, and 5 support workers.

Main Results:

  • Identified core outcomes for age-related macular degeneration trials.
  • Key outcomes include outer retina health, lesion size estimation, reading speed, visual acuity (distance, near, low luminance), patient-reported visual performance, and safety.

Conclusions:

  • A core outcome set (COS) for GA trials has been identified.
  • The proposed COS includes patient-reported outcomes, near visual acuity, reading speed, and outer retina assessment.
  • This COS aims to standardize and improve future GA clinical trial designs.