Evidence map›Paper›PMID 29746405›Full record

ArticleRetina (Philadelphia, Pa.)2019

LONG-TERM PHYSICAL STABILITY, STERILITY, AND ANTI-VEGF BIOACTIVITY OF REPACKAGED BEVACIZUMAB IN 2-ML GLASS VIALS.

Jan S Peterson, Kenneth Rockwell, Ingrid U Scott, Michael S Ip, Paul C VanVeldhuisen, Barbara A Blodi, SCORE2 Investigator Group

Registry-linked trialAbstract readComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Retina (Philadelphia, Pa.), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01969708 (Study of COmparative Treatments for REtinal Vein Occlusion 2 [SCORE2]), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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.

NCT01969708 phase3completednot on this map

Study of COmparative Treatments for REtinal Vein Occlusion 2 [SCORE2]: a Multicenter, Prospective, Randomized Non-inferiority Trial of Eyes With Macular Edema Secondary to Central Retinal Vein Occlusion, Comparing Intravitreal Bevacizumab Every 4 Weeks With Intravitreal Aflibercept Every 4 Weeks.

TypeinterventionalSponsorThe Emmes Company, LLCRan2014 to 2021Enrolled362ConditionsCentral Retinal Vein OcclusionArmsaflibercept, bevacizumab
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Short-term study on in-use stability of opened bevacizumab biosimilar PF-06439535 vials.European journal of hospital pharmacy : science and practice · 2022
    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

7 authors.

Jan S PetersonThe Emmes Corporation, Rockville, Maryland.
Kenneth RockwellInvestigational Drug Service, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.
Ingrid U ScottDepartments of Ophthalmology and Public Health Sciences, Penn State College of Medicine, Hershey, Pennsylvania.
Michael S IpDoheny Eye Institute, University of California-Los Angeles, Los Angeles, California.
Paul C VanVeldhuisenThe Emmes Corporation, Rockville, Maryland.
Barbara A BlodiFundus Photograph Reading Center, University of Wisconsin, Madison, Wisconsin.
SCORE2 Investigator Group

Funding

SCORE2 Comparative Trial (SCT)U10EY023533 · NEI · PENNSYLVANIA STATE UNIV HERSHEY MED CTR · PI SCOTT, INGRID U · 2013 to 2018
$7.4M
SCORE2 Comparative Trial (SCT)U10EY023529 · NEI · THE EMMES COMPANY, LLC · PI VAN VELDHUISEN, PAUL C · 2013 to 2018
$6.8M
The SCORE2 Long-Term Follow-Up (SCORE2 LTF)UG1EY023533 · NEI · PENNSYLVANIA STATE UNIV HERSHEY MED CTR · PI SCOTT, INGRID U · 2019 to 2021
$3.7M
SCORE2 Comparative Trial (SCT)U10EY023521 · NEI · UNIVERSITY OF WISCONSIN-MADISON · PI BLODI, BARBARA A · 2013 to 2018
$1.8M
NEI NIH HHS U10 EY023521NEI NIH HHS U10 EY023529NEI NIH HHS U10 EY023533NEI NIH HHS UG1 EY023533
6 · The paper itself

Abstract

purposeRepackaged bevacizumab in single-dose, prefilled syringes for intravitreal injection is available, but with shelf life limited from 60 days to 90 days. For the Study of COmparative Treatments for REtinal Vein Occlusion 2 (SCORE2), 2-mL sterile glass vials were used rather than prefilled syringes to provide a longer shelf life for study supplies.

methodsRepackaged bevacizumab in glass vials was tested at release and, for 1 lot, after 1, 3, 6, and 12 months for physical stability, including concentration, purity and appearance, and for sterility and endotoxins. Vials from 2 lots were tested at release and after 20 months and 21 months, respectively. One lot was tested at 21 months for anti-VEGF bioactivity compared with a fresh supply of commercial bevacizumab.

resultsRepackaged bevacizumab in 2-mL glass vials continued to meet all quality release specifications and remain sterile for up to 21 months. In addition, no degradation in anti-VEGF bioactivity was observed at 21 months compared with a fresh bevacizumab control.

conclusionBevacizumab can be repackaged into small, single-dose glass vials for intravitreal injection and the qualities of the commercial product maintained, including anti-VEGF bioactivity, for up to 21 months in refrigerated storage. Consideration should be given to repackaging bevacizumab for ophthalmic use in small glass vials as opposed to plastic syringes.

Indexed as

Angiogenesis InhibitorsBevacizumabDrug PackagingDrug StabilityDrug StorageGlassHumansInfertilityIntravitreal InjectionsSyringesVascular Endothelial Growth Factor AAngiogenesis InhibitorsBevacizumabVascular Endothelial Growth Factor A

Identifiers

PMID29746405
PMCPMC6226382

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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.