Evidence map›Paper›PMID 36977936›Full record

Trial reportEye (London, England)2023

Visual acuity time in range: a novel concept to describe consistency in treatment response in diabetic macular oedema.

Igor Kozak, Ian Pearce, Chui Ming Gemmy Cheung, Tobias Machewitz, George N Lambrou, Daniel Molina, Lima Suleiman, Hossam Youssef, Neil M Bressler

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Eye (London, England), 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
2.8field-weighted citation impact, top 10% 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

8 citing papers in PubMed, 10 citations in OpenAlex.

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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

9 authors at 6 institutions in 5 countries.

Igor KozakMoorfields Eye Hospitals UAE, Abu Dhabi, United Arab Emirates. igor.kozak@moorfields.ae.ORCID 0000-0003-1813-0017
Ian PearceSt Paul's Eye Unit, Royal Liverpool University Hospital, Liverpool, UK.
Chui Ming Gemmy CheungSingapore National Eye Centre, Singapore Eye Research Institute, Singapore, Singapore.ORCID 0000-0003-3358-3516
Tobias MachewitzBayer AG, Berlin, Germany.
George N LambrouBayer Consumer Care AG, Basel, Switzerland.
Daniel MolinaBayer Consumer Care AG, Basel, Switzerland.
Lima SuleimanBayer Middle East FZE, Dubai, United Arab Emirates.
Hossam YoussefBayer Middle East FZE, Dubai, United Arab Emirates.
Neil M BresslerDepartment of Ophthalmology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Bayer (Switzerland) · CHBayer (Germany) · DEJohns Hopkins University · USMoorfields Eye Hospital · GBSingapore National Eye Center · SGUniversity of Liverpool · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo assess 'time in range' as a novel measure of treatment response in diabetic macular oedema (DMO).

methodsThis post hoc analysis of the Protocol T randomised clinical trial included 660 individuals with centre-involved DMO and best-corrected visual acuity (BCVA) letter score ≤78-≥24 (approximate Snellen equivalent 20/32-20/320). Study participants received intravitreal aflibercept 2.0 mg, repackaged (compounded) bevacizumab 1.25 mg, or ranibizumab 0.3 mg given up to every 4 weeks using defined retreatment criteria. Mean time in range was calculated using a BCVA letter score threshold of ≥69 (20/40 or better; minimum driving requirement in many regions), with sensitivity analyses using BCVA thresholds from 100 to 0 (20/10 to 20/800) in 1-letter increments.

resultsTime in range was defined as either the absolute or relative duration above a predefined BCVA threshold, measured in weeks or as a percentage of time, respectively. Using a BCVA letter score threshold of ≥69 (20/40 or better), the least squares mean time in range (adjusted for baseline BCVA) in Year 1 was 41.2 weeks with intravitreal aflibercept, 4.0 weeks longer (95% CI: 1.7, 6.3; p = 0.002) than bevacizumab and 3.6 weeks longer (1.3, 5.9; p = 0.004) than ranibizumab. Overall, mean time in range was numerically longer for intravitreal aflibercept for all BCVA letter score thresholds between 92 and 30 (20/20 to 20/250). In the Day 365-728 analysis, time in range was 3.9 (1.3, 6.5) and 2.4 (0.0, 4.9) weeks longer with intravitreal aflibercept vs bevacizumab and vs ranibizumab (p = 0.011 and 0.106), respectively.

conclusionBCVA time in range may represent another way to describe visual outcomes and potential impact on vision-related functions over time for patients with DMO and provide a better understanding, for physicians and patients, of the consistency of treatment efficacy.

Indexed as

Diabetes MellitusDiabetic RetinopathyMacular EdemaAngiogenesis InhibitorsBevacizumabHumansIntravitreal InjectionsRanibizumabReceptors, Vascular Endothelial Growth FactorVascular Endothelial Growth Factor AVisual AcuityAngiogenesis InhibitorsBevacizumabRanibizumabReceptors, Vascular Endothelial Growth FactorVascular Endothelial Growth Factor A

Identifiers

PMID36977936
PMCPMC10630493
OpenAlexW4361218481

What Socratic holds

Textmetadata
LicenceCC BY
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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 Socratic graph.