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Age-related Macular Degeneration (AMD)Phase 3COLUMBUS-AMDNCT02611778

Efficacy and Safety of the Biosimilar Ranibizumab FYB201 in Comparison to Lucentis in Patients With Neovascular Age-related Macular Degeneration

A Phase 3 study testing ranibizumab in people with Age-related Macular Degeneration (AMD), run by Bioeq GmbH at 58 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to determine the efficacy and safety of the biosimilar ranibizumab FYB201 in comparison to Lucentis in patients with neovascular age-related macular degeneration. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Age-related Macular Degeneration (AMD)
What is being tested?
ranibizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
712 participants
Where
58 sitesin 12 countries
Study dates
19 Dec 2015to 6 Jun 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 50 years of either gender
  • Signed informed consent form must be obtained before any study-related procedure is performed
  • Willingness and ability to undertake all scheduled visits and assessments
  • Women must be postmenopausal or surgically sterile
  • Newly diagnosed, angiographically documented, primary active Choroidal Neovascularization (CNV) lesion secondary to age-related macular degeneration (AMD)
  • Sufficiently clear ocular media and adequate pupillary dilation to permit good quality ocular imaging
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  • Best-corrected Visual Acuity (BCVA) in the study eye, determined by standardized Early Treatment Diabetic Retinopathy Study (ETDRS) testing, between 20/32 (0.63) and 20/100 (0.2) Snellen equivalent
  • Foveal Center Point (FCP) retinal thickness in at Screening ≥ 350 µm
  • BCVA in the fellow eye, determined by standardized ETDRS testing, at least 20/100 (0.2) Snellen equivalent

Who cannot join

  • 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
  • Any previous treatment with intravitreal (IVT) anti-vascular endothelial growth factor (VEGF) agent in either eye
  • History of vitrectomy, macular surgery or other surgical intervention for AMD in the study eye
  • History of IVT or periocular injections of corticosteroids or device implantation within six months prior to Screening in the study eye
  • Prior treatment with verteporfin (photodynamic therapy), transpupillary thermotherapy, radiation therapy, or retinal laser treatment (e.g. focal laser photocoagulation) in the study eye
  • Topical ocular corticosteroids administered for at least 30 consecutive days within three months prior to Screening
Show all 33Show fewer
  • Any other intraocular surgery (including cataract surgery) in the study eye within three months prior to Screening
  • Sub- or intra-retinal hemorrhage that comprises more than 50% of the entire lesion in the study eye
  • Fibrosis or atrophy involving the center of the fovea or influencing central visual function in the study eye
  • CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia
  • Retinal pigment epithelial tear involving the macula in the study eye
  • History of full-thickness macular hole in the study eye
  • History of retinal detachment in the study eye
  • Current vitreous hemorrhage in the study eye
  • Spherical equivalent of the refractive error in the study eye demonstrating more than 8 diopters of myopia
  • For patients who have undergone prior refractive or cataract surgery in the study eye, the preoperative refractive error in the study eye cannot exceed 8 diopters of myopia
  • History of corneal transplant in the study eye
  • Aphakia in the study eye. Absence of an intact posterior capsule is allowed if it occurred as a result of Yttrium-Aluminium-Garnet (YAG) laser posterior capsulotomy in association with prior posterior chamber intraocular lens (IOL) implantation
  • Active or recent (within 4 weeks) intraocular inflammation of clinical significance in the study eye such as active infections of the anterior segment (excluding mild blepharitis) including conjunctivitis, keratitis, scleritis, uveitis or endophthalmitis
  • Uncontrolled hypertension or glaucoma in the study eye (defined as intraocular pressure (IOP) ≥30 mm Hg, despite treatment with anti-glaucomatous medication)
  • Ocular disorders in the study eye (i.e. retinal detachment, pre-retinal membrane of the macula or cataract with significant impact on visual acuity) at the time of enrollment that may confound interpretation of study results and compromise visual acuity
  • Any concurrent intraocular condition in the study eye (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 Screening, 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 three months prior to Screening
  • Presence of uncontrolled systolic blood pressure > 160 mmHg or uncontrolled diastolic blood pressure > 100 mmHg
  • Known hypersensitivity to the investigational drug (ranibizumab or any component of the ranibizumab formulation) or to drugs of similar chemical class or to fluorescein or any other component of fluorescein formulation
  • Current or planned use of systemic medications known to be toxic to the lens, retina or optic nerve, including deferoxamine, chloroquine/hydroxychloroquine (Plaquenil®), tamoxifen, phenothiazines and ethambutol
  • History of recurrent significant infections and/or current treatment for active systemic infection
  • Pregnancy or lactation
  • Systemic treatment with high doses of corticosteroids (administration of >10 mg/day of prednisolone equivalent) during the last six months prior to Screening
  • Inability to comply with study or follow-up procedures
  • Any diagnosis and/or signs of nAMD requiring treatment with an IVT anti-VEGF agent (e.g. aflibercept, bevacizumab, ranibizumab) within the screening period or at study treatment initiation (Visit 1) in the fellow eye

Trial locations and contacts

58 sites in 12 countries.

58 sites in 12 countries

Israel9 sites

  • Research Site

    Beersheba

  • Research Site

    Haifa

  • Research Site

    Jerusalem

  • Research Site

    Kfar Saba

  • Research Site

    Petah Tikva

  • Research Site

    Ramat Gan

  • Research Site

    Rehovot

  • Research Site

    Tel Aviv

  • Research Site

    Zrifin

Other trials in Israel

Germany8 sites

  • University of Bonn, Department of Ophthalmology

    Bonn

  • Research Site

    Dresden

  • Research Site

    Freiburg im Breisgau

  • Research Site

    Göttingen

  • Research Site

    Hanover

  • Research Site

    Leipzig

  • Research Site

    Mainz

  • Research Site

    Tübingen

Other trials in Germany

Hungary6 sites

  • Research Site

    Budapest

  • Research Site

    Debrecen

  • Research Site

    Nyíregyháza

  • Research Site

    Pécs

  • Research Site

    Szeged

  • Research Site

    Zalaegerszeg

Other trials in Hungary

Italy6 sites

  • Research Site

    Bologna

  • Research Site

    Chieti

  • Research Site

    Milan

  • Research Site

    Pisa

  • Research Site

    Roma

  • Research Site

    Torino

Other trials in Italy

Poland6 sites

  • Research Site

    Bydgoszcz

  • Research Site

    Lodz

  • Research Site

    Rzeszów

  • Research Site

    Tarnów

  • Research Site

    Tarnowskie Góry

  • Research Site

    Warsaw

Other trials in Poland

Czechia5 sites

  • Research Site

    Brno

  • Research Site

    Ostrava

  • Research Site

    Pilsen

  • Research Site

    Prague

  • Research Site

    Zlín

Other trials in Czechia

United Kingdom5 sites

  • Research Site

    Bradford

  • Research Site

    Bristol

  • Research Site

    Camberley

  • Research Site

    London

  • Research Site

    Rugby

Other trials in United Kingdom

France4 sites

  • Research Site

    Dijon

  • Research Site

    Lyon

  • Research Site

    Nantes

  • Research Site

    Paris

Other trials in France

Russia3 sites

  • Research Site

    Kazan'

  • Research Site

    Moscow

  • Research Site

    Saint Petersburg

Other trials in Russia

Spain3 sites

  • Research Site

    Barcelona

  • Research Site

    Valencia

  • Research Site

    Zaragoza

Other trials in Spain

Ukraine2 sites

  • Research Site

    Kyiv

  • Research Site

    Odesa

Other trials in Ukraine

Austria1 site

  • Research Site

    Vienna

Other trials in Austria

About this study

The purpose of this study is to determine the efficacy and safety of the biosimilar ranibizumab FYB201 in comparison to Lucentis in patients with neovascular age-related macular degeneration.

Being tested
ranibizumab
Medical subject headings
Macular Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02611778
Study groupRoleWhat they receive
FYB201ExperimentalFYB201 is provided as single use vials and will be administered by intra-vitreal injection.
Receives: Biological: ranibizumab
LucentisActive comparatorLucentis® is provided as single use vials and will be administered by intra-vitreal injection.
Receives: Biological: ranibizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Best Corrected Visual Acuity (BCVA) [Letters] After 8 Weeks

    The primary endpoint was the absolute change from baseline in BCVA by Early Treatment Diabetic Retinopathy Study (ETDRS) letters after 2 months (8 weeks) of treatment.

    Measured: Baseline and Week 8

Secondary outcomes (16)

  1. Change From Baseline in Best Corrected Visual Acuity (BCVA) [Letters] After 24 Weeks

    Absolute change from baseline in BCVA by Early Treatment Diabetic Retinopathy Study (ETDRS) letters after 24 weeks of treatment.

    Measured: Baseline and Week 24

  2. Change From Baseline in Best Corrected Visual Acuity (BCVA) [Letters] After 48 Weeks

    Absolute change from baseline in BCVA by Early Treatment Diabetic Retinopathy Study (ETDRS) letters after 48 weeks of treatment.

    Measured: Baseline and Week 48

  3. Change From Baseline in Best Corrected Visual Acuity (BCVA) [Letters] After 12 Months

    Absolute change from baseline in BCVA by Early Treatment Diabetic Retinopathy Study (ETDRS) letters after 12 months, calculated as the average of the changes from baseline to Week 40, to Week 44 and to Week 48.

    Measured: Baseline and 12 Months

  4. Change in Foveal Centre Point (FCP) Retinal Thickness From Baseline to Week 24

    Absolute change in Foveal Centre Point (FCP) retinal thickness [µm] from baseline to Week 24

    Measured: Baseline and Week 24

  5. Change in Foveal Centre Point (FCP) Retinal Thickness From Baseline to Week 48

    Absolute change in Foveal Centre Point (FCP) retinal thickness [µm] from baseline to Week 48

    Measured: Baseline and Week 48

  6. Change in Foveal Central Subfield (FCS) Retinal Thickness From Baseline to Week 24

    Absolute change in Foveal Central Subfield (FCS) retinal thickness [µm] from baseline to Week 24

    Measured: Baseline and Week 24

  7. Change in Foveal Central Subfield (FCS) Retinal Thickness From Baseline to Week 48

    Absolute change in Foveal Central Subfield (FCS) retinal thickness [µm] from baseline to Week 48

    Measured: Baseline and Week 48

  8. Change in Total Lesion Area From Baseline to Week 24

    Absolute change in total lesion area [mm²] from baseline to Week 24

    Measured: Baseline and Week 24

  9. Change in Total Lesion Area From Baseline to Week 48

    Absolute change in total lesion area [mm²] from baseline to Week 48

    Measured: Baseline and Week 48

  10. Change in NEI VFQ-25 Composite Score From Baseline to Week 24

    Absolute change from baseline to Week 24 in vision-related functioning and well-being measured by the National Eye Institute Visual Function Questionnaire 25 (NEI VFQ-25) composite score.

    The NEI VFQ-25 is a 25 question quality of life questionnaire with possible item scores between 0 and 100. Higher scores represent better functioning. The composite score is calculated as average over all non-missing item scores.

    Measured: Baseline and Week 24

  11. Change in NEI VFQ-25 Composite Score From Baseline to Week 48

    Absolute change from baseline to Week 48 in vision-related functioning and well-being measured by the National Eye Institute Visual Function Questionnaire 25 (NEI VFQ-25) composite score.

    The NEI VFQ-25 is a 25 question quality of life questionnaire with possible item scores between 0 and 100. Higher scores represent better functioning. The composite score is calculated as average over all non-missing item scores.

    Measured: Baseline and Week 48

  12. Active CNV Leakage at Week 24

    Number and percentage of patients with active CNV leakage at Week 24

    Measured: Baseline and Week 24

  13. Active CNV Leakage at Week 48

    Number and percentage of patients with active CNV leakage at Week 48

    Measured: Baseline and Week 48

  14. Fluid-free Macula at Each Visit

    Number and percentage of patients with fluid-free macula at each visit

    Measured: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48

  15. Anti-drug Antibodies by Scheduled eCRF Visit

    Frequency of patients with anti-drug antibodies (ADAs) by scheduled eCRF visit

    Measured: Baseline and Weeks 1, 4, 12, 24, 48

  16. Anti-drug Antibodies Pre- and Post-first Dosing

    Number and percentage of patients with detection of anti-drug antibodies (ADAs) pre-first dosing and post-first dosing (combination of all ADA assessments after first injection of study medication).

    Measured: Baseline and up to Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Nov 2015 (estimated)
  2. Study start19 Dec 2015
  3. Primary completionDec 2017
  4. Study completion6 Jun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
712 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02611778
Sponsor's protocol ID
FYB201-C2015-01-P3
Acronym
COLUMBUS-AMD
Status last verified
Sep 2021
First submitted
19 Nov 2015
Last updated
30 Sep 2021
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ranibizumab in people with Age-related Macular Degeneration (AMD), run by Bioeq GmbH at 58 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 58 sites in Israel, Germany, Hungary, Italy, Poland and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Best Corrected Visual Acuity (BCVA) [Letters] After 8 Weeks (time frame: Baseline and Week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02611778.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2021.

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