Evidence map›Paper›PMID 25034049›Full record

ReviewThe British journal of ophthalmology2015

Biomarkers and surrogate endpoints in glaucoma clinical trials.

Felipe A Medeiros

Open access · greenAbstract readReview
In one paragraph

Review in The British journal of ophthalmology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 6 pooled it
5.4field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 6 syntheses or guidelines pooled it, 56 citations in OpenAlex.

  1. Pooled it
  2. Outcome measures in childhood glaucoma: a systematic review of randomized controlled trials.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2023
    Pooled it
  3. Pooled it
  4. Ab interno trabecular bypass surgery with iStent for open-angle glaucoma.The Cochrane database of systematic reviews · 2019
    Pooled it
  5. Pooled it
  6. Pooled it
  7. Trial
  8. Trial
  9. Review
  10. Article
  11. Review
  12. Article
  13. Article
  14. Article
  15. Angiopoietin-1 Knockout Mice as a Genetic Model of Open-Angle Glaucoma.Translational vision science & technology · 2020
    Article
  16. Article
  17. Impact of ab-interno trabeculectomy on Bruch's membrane opening-based morphometry of the optic nerve head for glaucoma progression analysis.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2019
    Article
  18. Review
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

1 author at 1 institution in 1 country.

Felipe A Medeiros
University of California, San Diego · US

Funding

Vision BiostatisticsP30EY022589 · NEI · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI LINDA M ZANGWILL · 2012 to 2026
$10.3M
Diagnostic Innovations in Glaucoma Study (DIGS): Functional ImpairmentR01EY021818 · NEI · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI MEDEIROS, FELIPE · 2011 to 2015
$3.4M
NEI NIH HHS EY021818NEI NIH HHS P30 EY022589NEI NIH HHS R01 EY021818
6 · The paper itself

Abstract

Surrogate endpoints are often used as replacements for true clinically relevant endpoints in several areas of medicine, as they enable faster and less expensive clinical trials. However, without proper validation, the use of surrogates may lead to incorrect conclusions about the efficacy and safety of treatments. This article reviews the general requirements for validating surrogate endpoints and provides a critical assessment of the use of intraocular pressure (IOP), visual fields, and structural measurements of the optic nerve as surrogate endpoints in glaucoma clinical trials. A valid surrogate endpoint must be able to predict the clinically relevant endpoint and fully capture the effect of an intervention on that endpoint. Despite its widespread use in clinical trials, no proper validation of IOP as a surrogate endpoint has ever been conducted for any class of IOP-lowering treatments. Evidence has accumulated with regard to the role of imaging measurements of optic nerve damage as surrogate endpoints in glaucoma. These measurements are predictive of functional losses in the disease and may explain, at least in part, treatment effects on clinically relevant endpoints. The use of composite endpoints in glaucoma trials may overcome weaknesses of the use of structural or functional endpoints in isolation. Unless research is dedicated to fully develop and validate suitable endpoints that can be used in glaucoma clinical trials, we run the risk of inappropriate judgments about the value of new therapies.

Indexed as

BiomarkersAntihypertensive AgentsClinical Trials as TopicDiagnostic ImagingEndpoint DeterminationGlaucomaHumansIntraocular PressureOptic DiskTonometry, OcularVisual FieldsAntihypertensive AgentsBiomarkersClinical TrialGlaucomaImagingIntraocular Pressure

Identifiers

PMID25034049
PMCPMC4523640
OpenAlexW2106993365

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.