Real-world data in retinal diseases treated with anti-vascular endothelial growth factor (anti-VEGF) therapy – a systematic approach to identify and characterize data sources

Abstract

Background Real-world data (RWD) has been a valuable addition to the scientific literature regarding treatment pathways, clinical outcomes and characteristics of patients with retinal diseases in recent years. Registries, observational studies and patient databases are often used for real-world research. However, there is limited information for each data source on the design, consistency, data captured, limitations and usability for assessing research questions. Using a systematic approach, we identified RWD sources for patients with retinal diseases and assessed them for completeness of data relating to different outcomes. Methods A systematic literature review was carried out to identify RWD sources for patients with retinal disease. Potentially relevant articles published between 2006 and 2016 were screened following electronic searches in Embase and MEDLINE. Congress and supplementary searches were undertaken to identify RWD sources that may not be referenced in full publications. For each data source, availability and quantity of data on baseline status, clinical outcomes, treatment and management, safety, and patient-reported and economic burden were assessed using a bespoke completeness assessment tool based on International Consortium for Health Outcomes Measurement guidelines for macular degeneration. Completeness of data for each area of interest in each data source was assessed and rated using a ‘good–moderate–poor’ rating system based on availability and quantity of available data. Each data source was then given an overall score based on its score for each of the 7 areas of interest. Results A total of 128 RWD sources from 32 countries were identified. Of the identified sources, 64 sources from 16 countries of interest were analyzed. Most of these sources provided information on baseline status and clinical outcomes and treatment, but few collected data on economic and patient-reported burden. Of the RWD sources analyzed, 10 scored highly in the overall completeness assessment, collecting data on most or all of the areas of interest; these sources are considered to be robust data sources for performing ophthalmology real-world studies. Conclusions The study provides a comprehensive list of RWD sources for patients with retinal disease, many of which will be useful for conducting real-world studies in the field of ophthalmology.

Extended real-world experience with the ILUVIEN® (fluocinolone acetonide) implant in the United Kingdom: 3-year results from the Medisoft® audit study

“…The goal of treating diabetic macular oedema (DMO) is to preserve or improve vision by reducing macular swelling [ 1 ]. Anti-vascular endothelial growth factor (VEGF) treatment is the first-line treatment for centre-involving DMO [ 2 – 4 ]. However, up to 66% of patients can have an insufficient response, despite initial intensive monthly anti-VEGF therapy [ 5 ].…”

Predictors of visual recovery in patients with macular edema secondary to central retinal vein occlusion after treatment with Conbercept

“…This causes the breakdown of the blood retinal barrier and ultimately leads to ME [ 3 ]. Many studies have shown that intravitreal anti-VEGF therapy is considered safe and effective for the treatment of CRVO-ME [ 4 , 5 ]. Conbercept, an anti-VEGF medication, is a humanized, soluble, VEGF receptor (VEGFR) protein comprising extracellular domain-2 of VEGFR1, and extracellular domains-3 and-4 of VEGFR-2.…”

Predictors of Visual Recovery in Patients with Macular Edema Secondary to Central Retinal Occlusion After Treatment with Conbercept

“…[3] Many studies have shown that intravitreal anti-VEGF therapy is considered safe and effective for the treatment of CRVO-ME. [4,5] Conbercept, an anti-VEGF medication, is a humanized, soluble, VEGF receptor (VEGFR) protein comprising extracellular domain-2 of VEGFR1, and extracellular domains-3 and-4 of VEGFR-2. Intravitreal injection of conbercept has been proven safe and effective for the treatment of CRVO-ME.…”