Evidence map›Paper›PMID 37294524›Full record

ArticleOphthalmology and therapy2023

Potential for Treatment Interval Extension in Eyes with nAMD Disease Activity Post Loading Phase in HAWK and HARRIER.

Ramin Tadayoni, Glenn J Jaffe, Frank G Holz, Ursula Schmidt-Erfurth, Kanji Takahashi, Chui Ming Gemmy Cheung, Seenu M Hariprasad, Kinfemichael Gedif, Rasmus Olsen, Catherine Best and 2 more

Open access · goldAbstract read
In one paragraph

Article in Ophthalmology and therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.3field-weighted citation impact, top 46% 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

2 citing papers in PubMed, 1 citations in OpenAlex.

  1. Article
  2. 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

12 authors at 11 institutions in 8 countries.

Ramin TadayoniOphthalmology Department, Université Paris Cité, AP-HP, Lariboisière, Saint Louis and Fondation Adolphe de Rothschild Hospitals, 2 Rue Ambroise Paré, 75010, Paris, France. ramin.tadayoni@aphp.fr.ORCID http://orcid.org/0000-0001-5616-3579
Glenn J JaffeDepartment of Ophthalmology, Duke University, Durham, NC, USA.
Frank G HolzDepartment of Ophthalmology, University of Bonn, Bonn, Germany.
Ursula Schmidt-ErfurthDepartment of Ophthalmology and Optometry, Medical University of Vienna, Vienna, Austria.
Kanji TakahashiDepartment of Ophthalmology, Kansai Medical University, Osaka, Japan.
Chui Ming Gemmy CheungSingapore Eye Research Institute, Singapore National Eye Center & Duke-NUS Medical School, Singapore, Singapore.
Seenu M HariprasadDepartment of Ophthalmology and Visual Science, University of Chicago, Chicago, IL, USA.
Kinfemichael GedifNovartis Pharmaceuticals, East Hanover, NJ, USA.
Rasmus OlsenNovartis Healthcare A/S, Copenhagen, Denmark.
Catherine BestNovartis Pharma A.G, Basel, Switzerland.
Franklin IgweNovartis Pharma A.G, Basel, Switzerland.
Peter K KaiserCole Eye Institute, Cleveland, OH, USA.
Novartis (Switzerland) · CHCleveland Eye Clinic · USDuke University · USKansai Medical University · JPMedical University of Vienna · ATNovartis (Denmark) · DKNovartis (United States) · USSingapore National Eye Center · SGUniversité Paris Cité · FRUniversity of Bonn · DEUniversity of Chicago · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe HAWK and HARRIER studies evaluated the efficacy and safety of brolucizumab versus aflibercept in treatment-naïve eyes with neovascular age-related macular degeneration. Based on the study design, brolucizumab-treated eyes adjusted to a q8w regimen because the presence of disease activity (DA) at the end of the matched loading phase (Week 16) could not subsequently extend to a q12w interval. The aim of this post hoc analysis was to assess subsequent DA in this subgroup to determine the potential for interval extensions during the first year of treatment.

methodsPooled data from the brolucizumab 6 mg arms and aflibercept arms of HAWK and HARRIER were included. Presence of DA was determined by the masked investigator based on their assessment of functional and anatomical parameters measured by optical coherence tomography. DA was compared at DA assessments, conducted at Weeks 16, 20, 32, and 44; fluid was also assessed at the primary analysis at Week 48.

resultsFewer brolucizumab- (22.8%) than aflibercept-treated (32.2%) eyes had DA at the first DA assessment at Week 16. In eyes with investigator-identified DA at Week 16, BCVA change from baseline to Week 96 was comparable between treatment arms. Fewer brolucizumab- than aflibercept-treated eyes had DA at each subsequent DA assessment in Year 1: 31.8% vs 39.1% (Week 20), 27.3% vs 43.5% (Week 32), and 17.3% vs 31.2% (Week 44). Fewer eyes treated with brolucizumab than aflibercept had intraretinal and/or subretinal fluid: 35.3% vs 43.5% (Week 20), 55.8% vs 69.6% (Week 32), 30.0% vs 43.1% (Week 44), and 48.6% vs 68.6% (Week 48).

conclusionThese findings indicate that, in eyes that still had DA 8 weeks after the final dose of loading phase, brolucizumab-treated eyes had improved fluid resolution and higher potential for treatment interval extension than aflibercept-treated eyes during the first year of treatment.

Indexed as

Anti-VEGF therapyBrolucizumabDisease activityInterval extensionNeovascular age-related macular degeneration

Identifiers

PMID37294524
PMCPMC10287590
OpenAlexW4379966961

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.