Evidence map›Paper›PMID 34932153›Full record

Trial reportGraefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie2022

Manifestations of intraocular inflammation over time in patients on brolucizumab for neovascular AMD.

Ramin Khoramnia, Marta S Figueroa, Lars-Olof Hattenbach, Carlos E Pavesio, Majid Anderesi, Robert Schmouder, Yu Chen, Marc D de Smet

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 2 pooled it
3.2field-weighted citation impact, top 7% 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

12 citing papers in PubMed, 2 syntheses or guidelines pooled it, 23 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Review
  5. Review
  6. Article
  7. Gains in the current understanding of managing neovascular AMD with brolucizumab.Journal of ophthalmic inflammation and infection · 2023
    Article
  8. Clinical features and associated factors of intraocular inflammation following intravitreal brolucizumab as switching therapy for neovascular age-related macular degeneration.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2023
    Article
  9. Article
  10. Article
  11. Article
  12. 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

8 authors at 5 institutions in 4 countries.

Ramin KhoramniaDepartment of Ophthalmology, The David J. Apple Center for Vision Research, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany. ramin.khoramnia@med.uni-heidelberg.de.ORCID http://orcid.org/0000-0002-6237-7773
Marta S FigueroaRetina Division, Ramón y Cajal University Hospital, Madrid, Spain.
Lars-Olof HattenbachDepartment of Ophthalmology, Ludwigshafen Hospital, Ludwigshafen am Rhein, Germany.
Carlos E PavesioDepartment of Uveitis, Moorfields Eye Hospital and UCL, London, UK.
Majid AnderesiNovartis Pharma AG, Basel, Switzerland.
Robert SchmouderNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Yu ChenNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Marc D de SmetMedical/Surgical Retina and Ocular Inflammation, Microinvasive Ocular Surgery Center (MIOS Sa), Lausanne, Switzerland.
Novartis (United States) · USHeidelberg University · DEKlinikum Ludwigshafen · DEMoorfields Eye Hospital · GBNovartis (Switzerland) · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo describe the adverse events associated with brolucizumab, in particular the sequence of intraocular inflammation (IOI), retinal vasculitis (RV), and/or retinal vascular occlusion (RO).

methodsThis was an unmasked post hoc analysis of the randomized HAWK/HARRIER clinical trials. Patients with neovascular AMD in the brolucizumab arms of the trials were included. IOI-related adverse events reported by study investigators were analyzed to determine early signs and the time course of IOI-related adverse events, using a subgroup of patients with definite/probable IOI cases identified in an independent unmasked post hoc review by an external safety review committee. A limited literature review on IOI following anti-VEGF therapy was also conducted.

resultsAmong 50 patients with definite/probable IOI cases identified by the safety review committee, 12 had RV or RO adverse events reported by the investigators. For 6 of 12, IOI (other than RV) was reported before RV or RO. The duration from the first IOI adverse event to the first RV or RO adverse event ranged from 16 to 171 days for 5 patients and was 553 days for 1 patient. Four of the 6 patients received ≥ 1 brolucizumab injection on or after the date of the first IOI adverse event and before the first RV or RO adverse event.

conclusionsIOI may precede RV or RO in some patients treated with brolucizumab.

Indexed as

Antibodies, Monoclonal, HumanizedWet Macular DegenerationAngiogenesis InhibitorsHumansInflammationRetinal VasculitisUveitisVascular Endothelial Growth Factor AVisual AcuityAngiogenesis InhibitorsAntibodies, Monoclonal, HumanizedbrolucizumabVascular Endothelial Growth Factor AAnti-vascular endothelial growth factorBrolucizumabIntraocular inflammationRetinal vascular occlusionRetinal vasculitis

Identifiers

PMID34932153
PMCPMC9061681
OpenAlexW4200376381

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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 OpenQuestion graph.