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New biosimilar shows promise for treating wet macular degeneration

NCT ID NCT04522167

Disease control Sponsor: Bioeq GmbH 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a new drug called FYB203, which is a biosimilar (a close copy) of the existing medication Eylea, for people with wet age-related macular degeneration (AMD), a leading cause of vision loss. The trial involved 434 participants and compared how well FYB203 worked versus Eylea in improving vision over 8 weeks. The goal was to see if FYB203 is as safe and effective as Eylea, offering a potentially more affordable treatment option for this chronic eye condition.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

434 people

The number who actually took part.

Started

Jul 2020

Finished

May 2023

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 years and older

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: * Age ≥ 50 years at Screening. * Male or female: * Male: A male patient must agree to use contraception as defined in this protocol during the treatment period and for at least 4 weeks after the last dose of study treatment. * Female: A female patient is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: 1. Not a woman of childbearing potential (WOCBP), OR 2. A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 4 weeks after the last dose of study treatment. * Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. * Willingness and ability to undertake all scheduled visits and assessments. * Newly diagnosed choroidal neovascularization (CNV) lesion secondary to wet AMD Exclusion Criteria: Patients are not eligible for the study if any of the following criteria apply: * Employees of clinical study sites, individuals directly involved with the conduct of the study or immediate family members thereof, prisoners, and persons who are legally institutionalized. * Study eye requiring immediate treatment. * Any prior treatment with VEGF agent or any investigational products to treat AMD in either eye. * Uncontrolled ocular hypertension or glaucoma in the SE (defined as intraocular pressure \[IOP\] ≥ 30 mmHg, despite treatment with anti-glaucomatous medication). * Ocular disorders in the SE (i.e. retinal detachment, pre-retinal membrane of the macula or cataract with significant impact on VA) at the time of screening that may confound interpretation of study results and compromise VA. * Any concurrent intraocular condition in the SE (e.g. glaucoma, cataract, or diabetic retinopathy) that, in the opinion of the Investigator, would either require surgical intervention during the study to prevent or treat visual loss that might result from that condition or affect interpretation of study results. * Use of other investigational drugs (excluding vitamins, minerals) within 30 days or 5 half lives from randomization, whichever is longer. * Any type of advanced, severe, or unstable disease, including any medical condition (controlled or uncontrolled) that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical status of the patient to a significant degree or put the patient at special risk. * Stroke or myocardial infarction within 6 months prior to randomization. * Known hypersensitivity to the IMP (aflibercept or any component of the aflibercept formulation) or to drugs of similar chemical class or to fluorescein or any other component of fluorescein formulation.

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Conditions

The condition(s) this trial relates to.

wet macular degeneration

As listed by the trial registrant

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

Neovascular age-related macular degeneration

Contacts and locations

Locations

  • Research Site

    Sofia, Bulgaria

  • Research Site

    Stara Zagora, Bulgaria

  • Research Site

    Hradec Králové, Czechia

  • Research Site

    Ostrava, Czechia

  • Research Site

    Pardubice, Czechia

  • Research Site

    Prague, Czechia

  • Research Site

    Sokolov, Czechia

  • Research Site

    Budapest, Hungary

  • Research Site

    Debrecen, Hungary

  • Research Site

    Pécs, Hungary

  • Research Site

    Szeged, Hungary

  • Research Site

    Székesfehérvár, Hungary

  • Research Site

    Tatabánya, Hungary

  • Research Site

    Zalaegerszeg, Hungary

  • Research Site

    Haifa, Israel

  • Research Site

    Jerusalem, Israel

  • Research Site

    Kfar Saba, Israel

  • Research Site

    Petah Tikva, Israel

  • Research Site

    Rehovot, Israel

  • Research Site

    Rishon LeZiyyon, Israel

  • Research Site

    Tel Aviv, Israel

  • Research Site

    Bologna, Italy

  • Research Site

    Florence, Italy

  • Research Site

    Milan, Italy

  • Research Site

    Roma, Italy

  • Research Site

    Rozzano, Italy

  • Research Site

    Udine, Italy

  • Research Site

    Akita, Japan

  • Research Site

    Amagasaki, Japan

  • Research Site

    Asahikawa, Japan

  • Research Site

    Chiyoda City, Japan

  • Research Site

    Chūō, Japan

  • Research Site

    Fukuoka, Japan

  • Research Site

    Fukushima, Japan

  • Research Site

    Hamamatsu, Japan

  • Research Site

    Himeji, Japan

  • Research Site

    Hirakata, Japan

  • Research Site

    Kita-ku, Japan

  • Research Site

    Kurume, Japan

  • Research Site

    Meguro City, Japan

  • Research Site

    Nagasaki, Japan

  • Research Site

    Nagoya, Japan

  • Research Site

    Sapporo, Japan

  • Research Site

    Shinjuku-Ku, Japan

  • Research Site

    Suita, Japan

  • Research Site

    Toride, Japan

  • Research Site

    Yokosuka, Japan

  • Research Site

    Bielsko-Biala, Poland

  • Research Site

    Bydgoszcz, Poland

  • Research Site

    Krakow, Poland

  • Research Site

    Lodz, Poland

  • Research Site

    Olsztyn, Poland

  • Research Site

    Tarnów, Poland

  • Research Site

    Warsaw, Poland

  • Research Site

    Chelyabinsk, Russia

  • Research Site

    Kazan', Russia

  • Research Site

    Moscow, Russia

  • Research Site

    Novosibirsk, Russia

  • Research Site

    Saint Petersburg, Russia

  • Research Site

    Kharkiv, Ukraine

  • Research Site

    Kherson, Ukraine

  • Research Site

    Kropyvnytskyi, Ukraine

  • Research Site

    Lutsk, Ukraine

  • Research Site

    Odesa, Ukraine

  • Research Site

    Poltava, Ukraine

  • Research Site

    Zaporizhzhya, Ukraine

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