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New eye drug brolucizumab tested in Real-World patients

NCT ID NCT04543331

Knowledge-focused 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jul 30, 2026 · Updated 3 times

Summary

This completed study observed 572 patients with neovascular age-related macular degeneration or diabetic macular edema who were already receiving brolucizumab injections. Researchers collected routine medical data to see how well the drug resolved fluid in the eye and improved vision in real-world settings. The study did not impose a strict treatment schedule, reflecting actual clinical practice.

What this could mean

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

Active substance
brolucizumab (a drug injected into the eye to reduce fluid and improve vision)
What this could lead to
If successful, this study could show that brolucizumab works well in everyday clinical practice, potentially leading to better treatment schedules for patients with these eye conditions.
What could go wrong
This is an observational study, not a controlled trial, so results may be influenced by patient selection and real-world variability. It does not prove cause and effect.

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.

Participants

572 people

The number who actually took part.

Started

Nov 2020

Finished

Nov 2025

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.

Who is studied

Patients being treated for nAMD or DME with brolucizumab will be enrolled in the study upon signing an informed consent.

Ages

18 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: The unit of analysis is patient-eye, i.e. all criteria should be applied to the study eye, unless otherwise specified. Patients will be included in the study if they fulfil the following requisites: 1. Diagnosis of nAMD or visual impairment due to DME 2. Male and Female nAMD and DME patients with ≥18 years of age at index 3. Decision to treat with brolucizumab at baseline visit 4. Signed written informed consent 5. Patients for whom a therapy with brolucizumab is medically indicated 6. Intraretinal and/or subretinal fluid affecting the central subfield of the study eye at Screening Exclusion Criteria: 1. Patients that have any contraindication or are not eligible for treatment with brolucizumab as according to the SmPC 2. Patients treated for RVO or CNV other than nAMD 3. Receipt of any anti-VEGF treatment other than brolucizumab in the study eye at index date 4. Central subfield of the study eye affected by fibrosis or geographic atrophy or total area of fibrosis \>50% of the total lesion (nAMD) 5. Any active intraocular or periocular infection or active intraocular inflammation in either eye at index date 6. Patients who have been on anti-VEGF treatment for longer than 3 years (before index date) 7. Any medical or psychological condition in the treating physician's opinion which may prevent the patient from the 24 months study participation 8. Patients participating in parallel in an interventional clinical trial 9. Patients participating in parallel in any other NIS generating primary data for an anti-VEGF drug 10. Laser photocoagulation (focal/grid or panretinal) in the study eye during the 3-month period prior to baseline 11. Prior use of intraocular or periocular corticosteroids in the study eye provided at least 4 months prior to baseline 12. Pregnancy and breast-feeding

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Conditions

The condition(s) this trial relates to.

diabetic macular edema wet macular degeneration

As listed by the trial registrant

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

Diabetic macular edema (DME) Neovascular age-related macular degeneration (NAMD)

Contacts and locations

Locations

  • Novartis Investigative Site

    Munich, Bavaria, 81377, Germany

  • Novartis Investigative Site

    Neuburg A.d. Donau, Bavaria, 86633, Germany

  • Novartis Investigative Site

    Würzburg, Bavaria, 97070, Germany

  • Novartis Investigative Site

    Würzburg, Bavaria, 97080, Germany

  • Novartis Investigative Site

    Frankfurt am Main, Hesse, 60590, Germany

  • Novartis Investigative Site

    Göttingen, Lower Saxony, 37075, Germany

  • Novartis Investigative Site

    Osnabrück, Lower Saxony, 49076, Germany

  • Novartis Investigative Site

    Rostock, Mecklenburg-Vorpommern, 18057, Germany

  • Novartis Investigative Site

    Trier, Rhineland-Palatinate, 54296, Germany

  • Novartis Investigative Site

    Saarbrücken, Saarland, 66111, Germany

  • Novartis Investigative Site

    Dresden, Saxony, 01307, Germany

  • Novartis Investigative Site

    Leipzig, Saxony, 04103, Germany

  • Novartis Investigative Site

    Schneeberg, Saxony, 08289, Germany

  • Novartis Investigative Site

    Halle, Saxony-Anhalt, 06118, Germany

  • Novartis Investigative Site

    Jena, Thuringia, 07740, Germany

  • Novartis Investigative Site

    Aschersleben, 06449, Germany

  • Novartis Investigative Site

    Bayreuth, 95445, Germany

  • Novartis Investigative Site

    Berlin, 10713, Germany

  • Novartis Investigative Site

    Berlin, 14163, Germany

  • Novartis Investigative Site

    Bonn, 53105, Germany

  • Novartis Investigative Site

    Breisach, 79206, Germany

  • Novartis Investigative Site

    Chemnitz, 09113, Germany

  • Novartis Investigative Site

    Cologne, 50968, Germany

  • Novartis Investigative Site

    Dresden, 01067, Germany

  • Novartis Investigative Site

    Dresden, 01324, Germany

  • Novartis Investigative Site

    Esslingen am Neckar, 73728, Germany

  • Novartis Investigative Site

    Glauchau, 08371, Germany

  • Novartis Investigative Site

    Homburg, 66421, Germany

  • Novartis Investigative Site

    Hösbach, 63768, Germany

  • Novartis Investigative Site

    Kiel, 24103, Germany

  • Novartis Investigative Site

    Leipzig, 04106, Germany

  • Novartis Investigative Site

    Magdeburg, 39104, Germany

  • Novartis Investigative Site

    Marienberg, 09496, Germany

  • Novartis Investigative Site

    Münster, 48145, Germany

  • Novartis Investigative Site

    Neubrandenburg, 17036, Germany

  • Novartis Investigative Site

    Schönebeck, 39218, Germany

  • Novartis Investigative Site

    Stralsund, 18435, Germany

  • Novartis Investigative Site

    Sulzbach, 66280, Germany

  • Novartis Investigative Site

    Torgau, 04860, Germany

  • Novartis Investigative Site

    Waren, 17192, Germany

  • Novartis Investigative Site

    Würzburg, 97080, Germany

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Other studies related to the condition(s) this trial covers.