Trial record 1 of 1 for:
ranibizumab | Bioeq [Lead]
Efficacy and Safety of the Biosimilar Ranibizumab FYB201 in Comparison to Lucentis in Patients With Neovascular Age-related Macular Degeneration (COLUMBUS-AMD)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02611778 |
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Recruitment Status :
Completed
First Posted : November 23, 2015
Results First Posted : September 30, 2021
Last Update Posted : September 30, 2021
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Sponsor:
Bioeq GmbH
Information provided by (Responsible Party):
Bioeq GmbH
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Age-related Macular Degeneration (AMD) | Biological: ranibizumab | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 712 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Efficacy and Safety of the Biosimilar Ranibizumab FYB201 in Comparison to Lucentis in Patients With Neovascular Age-related Macular Degeneration |
| Actual Study Start Date : | December 19, 2015 |
| Actual Primary Completion Date : | December 2017 |
| Actual Study Completion Date : | June 6, 2018 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Age-related macular degeneration
MedlinePlus related topics:
Macular Degeneration
Drug Information available for:
Ranibizumab
| Arm | Intervention/treatment |
|---|---|
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Experimental: FYB201
FYB201 is provided as single use vials and will be administered by intra-vitreal injection.
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Biological: ranibizumab |
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Active Comparator: Lucentis
Lucentis® is provided as single use vials and will be administered by intra-vitreal injection.
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Biological: ranibizumab |
Primary Outcome Measures :
- Change From Baseline in Best Corrected Visual Acuity (BCVA) [Letters] After 8 Weeks [ Time Frame: Baseline and Week 8 ]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.
Secondary Outcome Measures :
- Change From Baseline in Best Corrected Visual Acuity (BCVA) [Letters] After 24 Weeks [ Time Frame: Baseline and Week 24 ]Absolute change from baseline in BCVA by Early Treatment Diabetic Retinopathy Study (ETDRS) letters after 24 weeks of treatment.
- Change From Baseline in Best Corrected Visual Acuity (BCVA) [Letters] After 48 Weeks [ Time Frame: Baseline and Week 48 ]Absolute change from baseline in BCVA by Early Treatment Diabetic Retinopathy Study (ETDRS) letters after 48 weeks of treatment.
- Change From Baseline in Best Corrected Visual Acuity (BCVA) [Letters] After 12 Months [ Time Frame: Baseline and 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.
- Change in Foveal Centre Point (FCP) Retinal Thickness From Baseline to Week 24 [ Time Frame: Baseline and Week 24 ]Absolute change in Foveal Centre Point (FCP) retinal thickness [µm] from baseline to Week 24
- Change in Foveal Centre Point (FCP) Retinal Thickness From Baseline to Week 48 [ Time Frame: Baseline and Week 48 ]Absolute change in Foveal Centre Point (FCP) retinal thickness [µm] from baseline to Week 48
- Change in Foveal Central Subfield (FCS) Retinal Thickness From Baseline to Week 24 [ Time Frame: Baseline and Week 24 ]Absolute change in Foveal Central Subfield (FCS) retinal thickness [µm] from baseline to Week 24
- Change in Foveal Central Subfield (FCS) Retinal Thickness From Baseline to Week 48 [ Time Frame: Baseline and Week 48 ]Absolute change in Foveal Central Subfield (FCS) retinal thickness [µm] from baseline to Week 48
- Change in Total Lesion Area From Baseline to Week 24 [ Time Frame: Baseline and Week 24 ]Absolute change in total lesion area [mm²] from baseline to Week 24
- Change in Total Lesion Area From Baseline to Week 48 [ Time Frame: Baseline and Week 48 ]Absolute change in total lesion area [mm²] from baseline to Week 48
- Change in NEI VFQ-25 Composite Score From Baseline to Week 24 [ Time Frame: Baseline and 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.
- Change in NEI VFQ-25 Composite Score From Baseline to Week 48 [ Time Frame: Baseline and 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.
- Active CNV Leakage at Week 24 [ Time Frame: Baseline and Week 24 ]Number and percentage of patients with active CNV leakage at Week 24
- Active CNV Leakage at Week 48 [ Time Frame: Baseline and Week 48 ]Number and percentage of patients with active CNV leakage at Week 48
- Fluid-free Macula at Each Visit [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 ]Number and percentage of patients with fluid-free macula at each visit
- Anti-drug Antibodies by Scheduled eCRF Visit [ Time Frame: Baseline and Weeks 1, 4, 12, 24, 48 ]Frequency of patients with anti-drug antibodies (ADAs) by scheduled eCRF visit
- Anti-drug Antibodies Pre- and Post-first Dosing [ Time Frame: Baseline and up to Week 48 ]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).
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| Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- 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
- 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
Exclusion criteria:
- 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
- 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02611778
Locations
Show 58 study locations
Sponsors and Collaborators
Bioeq GmbH
Investigators
| Principal Investigator: | Frank G. Holz, Prof. Dr. | University of Bonn, Department of Ophthalmology |
Study Documents (Full-Text)
Documents provided by Bioeq GmbH:
Documents provided by Bioeq GmbH:
Study Protocol [PDF] August 29, 2017
Statistical Analysis Plan [PDF] April 16, 2018
| Responsible Party: | Bioeq GmbH |
| ClinicalTrials.gov Identifier: | NCT02611778 |
| Other Study ID Numbers: |
FYB201-C2015-01-P3 |
| First Posted: | November 23, 2015 Key Record Dates |
| Results First Posted: | September 30, 2021 |
| Last Update Posted: | September 30, 2021 |
| Last Verified: | September 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Additional relevant MeSH terms:
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Ranibizumab Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases Angiogenesis Inhibitors |
Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents |