Evidence map›Paper›PMID 42287526›Full record

ArticleOphthalmology and therapy2026

Intraocular Pressure Outcomes with Intravitreal Aflibercept 8 mg: A 96-Week Pooled Analysis from PULSAR and PHOTON.

Anat Loewenstein, Ursula Schmidt-Ott, Diana V Do, Paolo Lanzetta, Sergio Leal, Alyson J Berliner, Karen W Chu, Mark R Barakat, Ghassan Ghorayeb, Michael W Stewart and 11 more

2 registry-linked trialsAbstract read
In one paragraph

Article in Ophthalmology and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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.

NCT04423718 phase3completednot on this map

Randomized, Double-Masked, Active-Controlled, Phase 3 Study of the Efficacy and Safety of High Dose Aflibercept in Patients With Neovascular Age-Related Macular Degeneration

TypeinterventionalSponsorBayerRan2020 to 2024Enrolled1,011ConditionsNeovascular Age-Related Macular DegenerationArmsAflibercept High Dose VEGF Trap-Eye (BAY86-5321), Aflibercept VEGF Trap-Eye (Eylea, BAY86-5321)
NCT04429503 phase2 / phase3completednot on this map

A Randomized, Double-Masked, Active-Controlled Phase 2/3 Study of the Efficacy and Safety of High-Dose Aflibercept in Patients With Diabetic Macular Edema

TypeinterventionalSponsorRegeneron PharmaceuticalsRan2020 to 2024Enrolled660ConditionsDiabetic Macular Edema, Type 1 Diabetes Mellitus, Type 2 Diabetes MellitusArmsaflibercept, High-dose aflibercept
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

21 authors.

Anat LoewensteinOphthalmology Division, Tel Aviv Medical Center, Affiliated with Faculty of Medicine Tel Aviv University, Tel Aviv, Israel.
Ursula Schmidt-OttBayer AG, Berlin, Germany.
Diana V DoByers Eye Institute, Stanford University School of Medicine, Palo Alto, CA, USA.
Paolo LanzettaDepartment of Medicine - Ophthalmology, University of Udine, and Istituto Europeo di Microchirurgia Oculare - IEMO, Udine, Italy. paolo.lanzetta@iemo.eu.ORCID http://orcid.org/0000-0003-3746-141X
Sergio LealBayer Consumer Care AG, Basel, Switzerland.
Alyson J BerlinerRegeneron Pharmaceuticals Inc., Tarrytown, NY, USA.
Karen W ChuRegeneron Pharmaceuticals Inc., Tarrytown, NY, USA.
Mark R BarakatRetina Macula Institute of Arizona, Scottsdale, AZ, USA.
Ghassan GhorayebDepartment of Ophthalmology and Visual Sciences, West Virginia University, Morgantown, WV, USA.
Michael W StewartMayo Clinic College of Medicine and Department of Ophthalmology, Mayo Clinic, Jacksonville, FL, USA.
Martin S SpitzerDepartment of Ophthalmology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Xin ZhangBayer Consumer Care AG, Basel, Switzerland.
April McCulloughRegeneron Pharmaceuticals Inc., Tarrytown, NY, USA.
Claudia TueckmantelBayer AG, Wuppertal, Germany.
Dianela AvilaBayer AG, Berlin, Germany.
Peter Morgan-WarrenBayer Consumer Care AG, Basel, Switzerland.
Lynne BrunckBayer Consumer Care AG, Basel, Switzerland.
Ajla DupljakRegeneron Pharmaceuticals Inc., Tarrytown, NY, USA.
Maggie HymowitzRegeneron Pharmaceuticals Inc., Tarrytown, NY, USA.
Anna PortnoyRegeneron Pharmaceuticals Inc., Tarrytown, NY, USA.
Richard GaleHull York Medical School, University of York, York, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThis abstract aimed to explore the potential effect of a higher injection volume with aflibercept 8 mg (70 μl) versus 2 mg (50 μl) on intraocular pressure (IOP).

methodsIn PULSAR (NCT04423718), patients with neovascular age-related macular degeneration (nAMD) were randomised 1:1:1 to receive aflibercept 2 mg every 8 weeks (2q8) or aflibercept 8 mg every 12 (8q12) or 16 weeks (8q16), after three initial monthly doses. In PHOTON (NCT04429503), patients with diabetic macular oedema (DME) were randomised 1:2:1 to receive 2q8 after five monthly doses or 8q12 or 8q16 after three initial monthly doses. Increased IOP or glaucoma-related treatment-emergent adverse events (TEAEs) and pre- and post-injection IOP measurements were pooled through week 96 and summarised descriptively.

resultsThe safety analysis set included 1667 patients (8 mg: n = 1164; 2 mg: n = 503). Baseline mean (SD) IOP was 15.0 (3.2) mmHg and 15.1 (3.0) mmHg in patients receiving aflibercept 8 mg and 2 mg, respectively. Rates of TEAEs related to glaucoma (including TEAE of IOP increases) were low and similar across treatment groups (8 mg: 9/1000 injections; 2 mg: 6/1000 injections). Rates of paracentesis were low (8 mg: 1/1000 injections; 2 mg: 0). Mean pre-injection IOP values measured at each visit were similar, with no sustained increase over time across treatment groups.

conclusionsComparable IOP outcomes and no long-term IOP or glaucoma-related effects were observed with aflibercept 8 mg versus aflibercept 2 mg through week 96.

trial registrationPULSAR (NCT04423718) and PHOTON (NCT04429503) trials.

Indexed as

AfliberceptDiabetic macular oedemaGlaucomaIntraocular pressureNeovascular age-related macular degenerationTreatment-emergent adverse events

Identifiers

PMID42287526
PMCPMC13315389

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.