Evidence map›Paper›PMID 20847709›Full record

Trial reportRetina (Philadelphia, Pa.)

A randomized pilot study of systemic immunosuppression in the treatment of age-related macular degeneration with choroidal neovascularization.

Robert B Nussenblatt, Gordon Byrnes, H Nida Sen, Steven Yeh, Lisa Faia, Catherine Meyerle, Keith Wroblewski, Zhuqing Li, Baoying Liu, Emily Chew and 4 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Retina (Philadelphia, Pa.). The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00304954 (Treatment of Choroidal Subretinal Neovascularization With Agents Directed Against the Immune Response), which is not on this map. Cited by 42 papers.

0numbers the graph read from it
0cells of the map it votes in
42citing papers in PubMed
7.7field-weighted citation impact, top 2% 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.

NCT00304954 phase2completednot on this map

Treatment of Choroidal Subretinal Neovascularization With Agents Directed Against the Immune Response

TypeinterventionalSponsorNational Eye Institute (NEI)Ran2006 to 2010Enrolled13ConditionsAge-Related Macular Degeneration, Choroidal NeovascularizationArmsIntravenous Daclizumab, Intravenous Infliximab, Observation, Oral Rapamycin
3 · Its place in the literature

Who cites it

42 citing papers in PubMed, 87 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
  4. Review
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  9. Review
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  11. Review
  12. Deletion of Socs3 in LysMMolecular neurodegeneration · 2021
    Article
  13. Article
  14. Article
  15. MTOR-initiated metabolic switch and degeneration in the retinal pigment epithelium.FASEB journal : official publication of the Federation of American Societies for Experimental Biology · 2020
    Article
  16. Review
  17. RemicadeBiologics : targets & therapy · 2019
    Review
  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

14 authors at 4 institutions in 1 country.

Robert B NussenblattLaboratory of Immunology, National Eye Institute, National Institutes of Health, Bethesda, Maryland 20892, USA. drbob@nei.nih.gov
Gordon Byrnes
H Nida Sen
Steven Yeh
Lisa Faia
Catherine Meyerle
Keith Wroblewski
Zhuqing Li
Baoying Liu
Emily Chew
Patti R Sherry
Penelope Friedman
Fred Gill
Frederick Ferris
National Eye Institute · USNational Institutes of Health · USElman Retina Group · USWalter Reed Army Institute of Research · US

Funding

Treatment of choroidal subretinal neovascularization with immune agentsZ01EY000439 · NEI · NATIONAL EYE INSTITUTE · PI NUSSENBLATT, ROBERT B. · 2006 to 2008
$886k
Treatment of choroidal subretinal neovascularization with immune agentsZIAEY000439 · NEI · NATIONAL EYE INSTITUTE · PI NUSSENBLATT, ROBERT · 2009 to 2011
$640k
Intramural NIH HHS Z01 EY000439
6 · The paper itself

Abstract

backgroundAge-related macular degeneration remains the leading cause of irreversible blindness in the United States and the developed world. Intravitreal injections of anti–vascular endothelial growth factor (VEGF) medications have become standard of care for the treatment of the wet form of the disease. Recent reports have demonstrated an association with various immune factors. We aimed to investigate the effect of immunosuppressive therapy in the clinical course of the wet form of the disease. We compared anti-VEGF therapy plus one of three systemic immunosuppressive therapies versus anti-VEGF therapy alone for recurrent choroidal neovascularization associated with age-related macular degeneration.

methodsThis was a pilot, Phase I/II, prospective, randomized, unmasked, single-center trial. Patients with subretinal exudation secondary to recurrent choroidal neovascularization associated with age-related macular degeneration were included in the study. Patients were randomized to 1 of 3 systemic arms immunosuppressive agents (daclizumab, rapamycin, or infliximab) for 6 months plus intraocular anti-VEGF therapy if indicated, compared with a group who received only anti-VEGF therapy if indicated.

resultsThe number of anti-VEGF injections per group, visual acuity, retinal thickness, and safety measures were assessed in all groups. Thirteen patients were randomized; comparing anti-VEGF injections before and during the study, a decrease in the number of injections from 0.73 injections per month to 0.42 for daclizumab and from 0.67 to 0.34 for sirolimus was seen, while no apparent decrease was seen for either infliximab or observation. Visual acuities were maintained in all groups.

conclusionThese preliminary data suggest that some immunosuppressive agents given systemically can alter the clinical course of the wet form of the disease and support the notion that more definitive clinical trials of immune mediation of age-related macular degeneration are indicated.

Indexed as

AgedAged, 80 and overAngiogenesis InhibitorsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedChoroidal NeovascularizationDaclizumabDrug Therapy, CombinationFemaleHumansImmunoglobulin GImmunosuppression TherapyImmunosuppressive AgentsInfliximabInfusions, IntravenousIntravitreal InjectionsAngiogenesis InhibitorsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedDaclizumabImmunoglobulin GImmunosuppressive AgentsInfliximabSirolimusVascular Endothelial Growth Factor AVEGFA protein, human

Identifiers

PMID20847709
PMCPMC3174007
OpenAlexW2335110838

What OpenQuestion holds

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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.