Evidence map›Paper›PMID 19752419›Full record

Trial reportArchives of ophthalmology (Chicago, Ill. : 1960)2009

A randomized trial comparing the efficacy and safety of intravitreal triamcinolone with observation to treat vision loss associated with macular edema secondary to central retinal vein occlusion: the Standard Care vs Corticosteroid for Retinal Vein Occlusion (SCORE) study report 5.

Michael S Ip, Ingrid U Scott, Paul C VanVeldhuisen, Neal L Oden, Barbara A Blodi, Marian Fisher, Lawrence J Singerman, Michael Tolentino, Clement K Chan, Victor H Gonzalez and 1 more

Erratum issued 2 registry-linked trialsOpen access · greenAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Archives of ophthalmology (Chicago, Ill. : 1960), 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Cited by 174 papers, 12 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
174citing papers in PubMed, 12 pooled it
59.0field-weighted citation impact, top 1% 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.

NCT00105027 phase3completednot on this map

The Standard Care vs. COrticosteroid for REtinal Vein Occlusion (SCORE) Study: Two Randomized Trials to Compare the Efficacy and Safety of Intravitreal Injection(s) of Triamcinolone Acetonide With Standard Care to Treat Macular Edema

TypeinterventionalSponsorThe Emmes Company, LLCRan2004 to 2009Enrolled682ConditionsMacular Edema, Cystoid, Retinal Vein OcclusionArmsStandard Care, intravitreal triamcinolone injection
NCT02880644 completednot on this mapstarted 2017, after this paper: background citation

Ultra-wide Fluorescein angiograpHy to Evaluate the Progression of Retinal ischeMia After aflibErcept Injections in patientS With Central Retinal Vein Occlusion in Real Life (HERMES Study)

Typeobservational_patient_registrySponsorCentre Hospitalier Intercommunal CreteilRan2017 to 2022Enrolled65ConditionsRetinal Vein Occlusion
3 · Its place in the literature

Who cites it

174 citing papers in PubMed, 12 syntheses or guidelines pooled it, 675 citations in OpenAlex.

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114 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 1 institution in 1 country.

Michael S IpEMMES Corporation, Rockville, MD 20850, USA.
Ingrid U Scott
Paul C VanVeldhuisen
Neal L Oden
Barbara A Blodi
Marian Fisher
Lawrence J Singerman
Michael Tolentino
Clement K Chan
Victor H Gonzalez
SCORE Study Research Group
Emmes (United States) · US

Funding

The Intravitreal Corticosteroid for Macular Edema StudyU10EY014351 · NEI · UNIVERSITY OF WISCONSIN-MADISON · PI IP, MICHAEL S · 2003 to 2008
$11.5M
SCORE2 Comparative Trial (SCT)U10EY023529 · NEI · THE EMMES COMPANY, LLC · PI VAN VELDHUISEN, PAUL C · 2013 to 2018
$6.8M
Intravitreal Corticosteroid for Macular EdemaU10EY014404 · NEI · THE EMMES COMPANY, LLC · PI VAN VELDHUISEN, PAUL C · 2003 to 2008
$3.8M
Intravitreal Corticosteroid for Macular Edema StudyU10EY014352 · NEI · UNIVERSITY OF WISCONSIN-MADISON · PI BLODI, BARBARA A · 2003 to 2008
$1.1M
NEI NIH HHS 5U10EY014351NEI NIH HHS 5U10EY014352NEI NIH HHS 5U10EY014404NEI NIH HHS U10 EY014351NEI NIH HHS U10 EY014352NEI NIH HHS U10 EY014404NEI NIH HHS U10 EY023529
6 · The paper itself

Abstract

objectiveTo compare the efficacy and safety of 1-mg and 4-mg doses of preservative-free intravitreal triamcinolone with observation for eyes with vision loss associated with macular edema secondary to perfused central retinal vein occlusion (CRVO).

methodsMulticenter, randomized, clinical trial of 271 participants.

main outcome measureGain in visual acuity letter score of 15 or more from baseline to month 12.

resultsSeven percent, 27%, and 26% of participants achieved the primary outcome in the observation, 1-mg, and 4-mg groups, respectively. The odds of achieving the primary outcome were 5.0 times greater in the 1-mg group than the observation group (odds ratio [OR], 5.0; 95% confidence interval [CI], 1.8-14.1; P = .001) and 5.0 times greater in 4-mg group than the observation group (OR, 5.0; 95% CI, 1.8-14.4; P = .001); there was no difference identified between the 1-mg and 4-mg groups (OR, 1.0; 95% CI, 0.5-2.1; P = .97). The rates of elevated intraocular pressure and cataract were similar for the observation and 1-mg groups, but higher in the 4-mg group.

conclusionsIntravitreal triamcinolone is superior to observation for treating vision loss associated with macular edema secondary to CRVO in patients who have characteristics similar to those in the SCORE-CRVO trial. The 1-mg dose has a safety profile superior to that of the 4-mg dose. Application to Clinical Practice Intravitreal triamcinolone in a 1-mg dose, following the retreatment criteria applied in the SCORE Study, should be considered for up to 1 year, and possibly 2 years, for patients with characteristics similar to those in the SCORE-CRVO trial. Trial Registration clinicaltrials.gov Identifier: NCT00105027.

Indexed as

AdultAgedAged, 80 and overFemaleFluorescein AngiographyFollow-Up StudiesGlucocorticoidsHumansInjectionsMacular EdemaMaleMiddle AgedObservationProspective StudiesRetinal Vein OcclusionRetreatmentGlucocorticoidsTriamcinolone Acetonide

Identifiers

PMID19752419
PMCPMC2872173
OpenAlexW1565832645

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

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.