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Eye drug dosing showdown: can fewer injections still control wet AMD?

NCT ID NCT04679935

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compared two different dosing schedules of brolucizumab (Beovu) in 52 people with wet age-related macular degeneration (AMD) who had not responded well to previous treatment. Participants received the drug as an eye injection either on a fixed schedule or with adjustments based on their eye health. The goal was to see which schedule better maintained vision and controlled the disease over 52 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
brolucizumab (Beovu), an anti-VEGF drug given as an eye injection
What this could lead to
If successful, this could help doctors choose a better dosing schedule for brolucizumab to control wet AMD with fewer injections.
What could go wrong
This is a small, completed Phase 4 study with only 52 participants, so results may not apply to all patients. The drug can cause eye inflammation or other side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

52 people

The number who actually took part.

Started

Jul 2021

Finished

Jan 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male or female patients ≥ 50 years of age at screening * Active choroidal neovascularization (CNV) secondary to AMD that affects the central subfield, including retinal angiomatous proliferation (RAP) with a CNV component, confirmed by presence of active leakage from CNV seen by fluorescein angiography and sequellae of CNV, e.g. pigment epithelial detachment (PED), subretinal or sub-retinal pigment epithelium (sub-RPE) hemorrhage, blocked fluorescence, macular edema (intraretinal fluid (IRF) and/or subretinal fluid (SRF) and/or sub-retinal pigment epithelium (sub-RPE) fluid that affects the central subfield, as seen by spectral domain optical coherence tomography (SD-OCT)) at screening, as confirmed by central reading center (study eye). If active CNV according to the above explained activity criteria is not detectable in screening image data (no IRF and no SRF), presence of residual and/or recurrent fluid (IRF and / or SRF) within the last 6 months before baseline visit is also considered eligible. In this case, historical images must be submitted for analysis by the central reading center. * Pretreatment with any anti-VEGF drug for a maximum of five years (60 months). Patients should have shown functional and/or anatomical treatment response to the pretreatment(s), prior to participating in this study. * The treatment initiation phase with the current anti-VEGF must have been completed for at least 6 months with continuous treatment in a ≥ q4w to ≤ q12w injection interval (±2-day window, i.e., 26 to 86 days inclusive) before the baseline visit. At least 4 weeks (minimum 26 days) must have passed between the last anti-VEGF pretreatment and baseline. * Best-corrected visual acuity (BCVA) score between 83 and 38 letters, inclusive, using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at both screening and baseline visit (study eye) Exclusion Criteria: * Any active intraocular or periocular infection or active intraocular inflammation, at screening or baseline (study eye) * Uncontrolled glaucoma defined as intraocular pressure (IOP) \> 25 mmHg on medication, or according to investigator's judgement, at screening or baseline (study eye) * Presence of amblyopia, amaurosis or ocular disorders in the fellow eye with BCVA \<20/200 at screening (except when due to conditions whose surgery may improve VA, e.g. cataract) * Ocular treatments: treatment with anti-VEGF drugs for \> 5 years in the study eye, pretreatment with brolucizumab at any time in the study eye, previous treatment with investigational drugs in the last 6 months, intraocular or periocular steroids at any time, macular laser photocoagulation or photodynamic therapy at any time, peripheral laser photocoagulation within 3 months prior to baseline, intraocular surgery within 3 months prior to baseline, vitreoretinal surgery at any time, aphakia with the absence of posterior capsule (study eye) * Stroke or myocardial infarction during the 6 month period prior to baseline * Systemic anti-VEGF therapy during the 3-month period prior to baseline

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Conditions

The condition(s) this trial relates to.

age-related macular degeneration choroidal neovascularization eye disorder Geographic Atrophy macular degeneration retinal degeneration retinal disorder vision disorder wet macular degeneration

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Age-related macular degeneration

Contacts and locations

Locations

  • Novartis Investigative Site

    Regensburg, Bavaria, 93053, Germany

  • Novartis Investigative Site

    Frankfurt am Main, Hesse, 60549, Germany

  • Novartis Investigative Site

    Berlin, 13353, Germany

  • Novartis Investigative Site

    Bonn, 53105, Germany

  • Novartis Investigative Site

    Düsseldorf, 40225, Germany

  • Novartis Investigative Site

    Göttingen, 37075, Germany

  • Novartis Investigative Site

    Hanover, 30625, Germany

  • Novartis Investigative Site

    Homburg, 66421, Germany

  • Novartis Investigative Site

    Leipzig, 04103, Germany

  • Novartis Investigative Site

    Lübeck, 23538, Germany

  • Novartis Investigative Site

    Magdeburg, 39120, Germany

  • Novartis Investigative Site

    Mainz, 55131, Germany

  • Novartis Investigative Site

    Marburg, 35039, Germany

  • Novartis Investigative Site

    Münster, 48149, Germany

  • Novartis Investigative Site

    Neubrandenburg, 17036, Germany

  • Novartis Investigative Site

    Ulm, 89075, Germany

  • Novartis Investigative Site

    Lausanne, CHE, 1000, Switzerland

  • Novartis Investigative Site

    Bern, 3007, Switzerland

  • Novartis Investigative Site

    Zurich, 8063, Switzerland

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