Evidence map›Paper›PMID 33593448›Full record

ArticleInternational journal of retina and vitreous2021

Intravitreal sirolimus for persistent, exudative age-related macular degeneration: a Pilot Study.

Robert J Minturn, Peter Bracha, Margaret J Klein, Jay Chhablani, Ashley M Harless, Raj K Maturi

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in International journal of retina and vitreous, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02357342 (Sirolimus Versus AntiVEGF for Wet AMD), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.7field-weighted citation impact, top 18% 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.

NCT02357342 phase2completednot on this map

Sirolimus Versus AntiVEGF for Wet AMD

TypeinterventionalSponsorMaturi, Raj K., M.D., P.C.Ran2015 to 2017Enrolled40ConditionsAge-Related Macular DegenerationArmsSirolimus, Standard of Care intravitreal injections of anti-VEGF
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 10 citations in OpenAlex.

  1. Review
  2. Article
  3. Review
  4. Review
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

6 authors at 5 institutions in 1 country.

Robert J MinturnDepartment of Ophthalmology, Indiana University School of Medicine, 10300 N Illinois St, Suite 1060, Indianapolis, IN, 46290, USA.
Peter BrachaGunderson Eye Institute, Gundersen Health System, La Crosse, WI, USA.
Margaret J KleinDepartment of Anesthesiology Critical Care Medicine, The Saban Research Institute At Children's Hospital, Los Angeles, CA, USA.
Jay ChhablaniUPMC Eye Center, University of Pittsburgh, Pittsburgh, PA, USA.
Ashley M HarlessMidwest Eye Institute, Indianapolis, IN, USA.
Raj K MaturiDepartment of Ophthalmology, Indiana University School of Medicine, 10300 N Illinois St, Suite 1060, Indianapolis, IN, 46290, USA. rmaturi@gmail.com.ORCID http://orcid.org/0000-0002-8894-1846
Midwest Eye Institute · USChildren's Hospital of Los Angeles · USGundersen Health System · USIndiana University School of MedicineUniversity of Pittsburgh Medical Center · US

Funding

Santen IST_RKM008
6 · The paper itself

Abstract

BACKGROUND AND

objectiveTo evaluate the safety and efficacy of intravitreal sirolimus for persistent, exudative age-related macular degeneration (AMD).

methodsThis institutional review board approved, registered (NCT02357342), prospective, subject-masked, single center, randomized controlled trial in subjects with persistent, exudative Age-related macular degeneration compared intravitreal sirolimus monotherapy (every 2 months) versus monthly anti-vascular endothelial growth factor (VEGF) over six months.

results20 subjects were randomized to each arm of the trial. Upon completion of the trial 20 patients were analyzed in the control (anti-vascular endothelial growth factor) group and 17 patients were analyzed in the treatment (sirolimus) group. On average, subjects had 33 previous anti-VEGF injections prior to entry. The primary end-point, mean central subfield thickness (CST), increased by 20 µm in the anti-vascular endothelial growth factor group and decreased by 40 µm in the sirolimus group (p = 0.03). Visual acuity outcomes were similar between groups. Serious ocular adverse events in the sirolimus group included one subject each with anterior uveitis, central retinal artery occlusion and subretinal hemorrhage.

conclusionMonotherapy with intravitreal sirolimus for subjects with persistent, exudative age-related macular degeneration appears to have a limited positive anatomic benefit. The presence of adverse events in the experimental group merits further evaluation, potentially as an adjuvant therapy. Trial registration This trial was registered with the clinicaltrials.gov, NCT02357342, and was approved by the institutional review board at Advarra. Funding was provided by an investigator-initiated grant from Santen. Santen played no role in the design or implementation of this study.

Indexed as

Anti-vascular endothelial growth factorExudative age-related macular degenerationRapamycinSirolimus

Identifiers

PMID33593448
PMCPMC7885608
OpenAlexW3132731533

What OpenQuestion holds

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LicenceCC BY
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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.