Subfoveal neovascular age-related macular degeneration MedDRA version: 20.0 Level: PT Classification code 10071129 Term: Neovascular age-related macular degeneration System Organ Class: 10015919 - Eye disorders MedDRA version: 20.0 Level: LLT Classification code 10067791 Term: Wet macular degeneration System Organ Class: 100000116602
Conditions
Interventions
Product Code: FYB201
Pharmaceutical Form: Solution for injection
INN or Proposed INN: RANIBIZUMAB
CAS Number: 347396-82-1
Current Sponsor code: FYB201
Concentration unit: mg/ml milligram(s)/millilitre
Sponsors
Bioeq GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age = 50 years of either gender 2. Signed informed consent form must be obtained before any study-related procedure is performed 3. Willingness and ability to undertake all scheduled visits and assessments 4. Women must be postmenopausal or surgically sterile 5. Newly diagnosed, angiographically documented, primary active CNV lesion secondary to age-related macular degeneration (AMD) 6. Sufficiently clear ocular media and adequate pupillary dilation to permit good quality ocular imaging Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 400
Exclusion criteria
Exclusion criteria: 1. Any prior treatment with IVT anti-vascular endothelial growth factor (VEGF) agent (e.g., bevacizumab, aflibercept, ranibizumab) in either eye 2. History of vitrectomy, macular surgery or other surgical intervention for AMD in the study eye 3. History of IVT or periocular injections of corticosteroids or device implantation within six months prior to Screening in the study eye 4. Prior treatment with verteporfin (photodynamic therapy), transpupillary thermotherapy, radiation therapy, or retinal laser treatment (e.g. focal laser photocoagulation) in the study eye 5. Topical ocular corticosteroids administered for at least 30 consecutive days within three months prior to Screening 6. Any other intraocular surgery (including cataract surgery) in the study eye within three months prior to Screening 7. Sub- or intra-retinal hemorrhage that comprises more than 50% of the entire lesion in the study eye 8. Fibrosis or atrophy involving the center of the fovea or influencing central visual function in the study eye 9. CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia 10. Retinal pigment epithelial tear involving the macula in the study eye 11. History of full-thickness macular hole (stage 2 and above by clinical examination or full thickness macular hole by SD-OCT imaging of any size) in the study eye 12. History of retinal detachment in the study eye 13. Current vitreous hemorrhage in the study eye 14. Spherical equivalent of the refractive error in the study eye demonstrating more than 8 diopters of myopia 15. 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 16. History of corneal transplant in the study eye 17. Aphakia in the study eye. Absence of an intact posterior capsule is allowed if it occurred as a result of YAG laser posterior capsulotomy in association with prior posterior chamber intraocular lens (IOL) implantation 18. 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 19. Uncontrolled hypertension or glaucoma in the study eye (defined as intraocular pressure [IOP] =30 mm Hg, despite treatment with anti-glaucomatous medication)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate and compare functional changes in best corrected visual acuity (BCVA) after 2 months (8 weeks) of treatment with FYB201 or Lucentis, compared to baseline BCVA;Secondary Objective: Evaluate and compare functional changes of the retina by BCVA over time Evaluate and compare changes in FCP retinal thickness and change in foveal central subfield retinal thickness over time Evaluate and compare presence of active choroidal neovascularization leakage at Month 6 and 12 compared to baseline Evaluate and compare the absence of disease activity (fluid-free macula) over time Evaluate and compare total lesion size at Month 6 and 12 compared to baseline Evaluate and compare systemic ranibizumab concentrations Evaluate and compare change in vision-related functioning and well-being measured by NEI VFQ-25 at Months 6 and 12 compared to baseline Evaluate and compare the immunogenic profile (anti-drug antibodies) in serum Evaluate and compare local and systemic adverse events and serious adverse events;Primary end point(s): Change from baseline in BCVA by ETDRS letters after 2 months (8 weeks) of treatment;Timepoint(s) of evaluation of this end point: 2 months (8 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Efficacy Endpoints • Change from baseline in BCVA by ETDRS letters • Changes from baseline in FCP retinal thickness and FCS retinal thickness • Percentage of patients with active CNV leakage • Percentage of patients with fluid-free macula at each visit • Change from baseline in total lesion area • Systemic ranibizumab concentrations • Change from baseline in vision-related functioning and well-being measured by NEI VFQ-25 • Number of patients with anti-ranibizumab antibodies • Frequency of local and systemic AEs and SAEs;Timepoint(s) of evaluation of this end point: Secondary Efficacy Endpoints • Change from baseline in BCVA by ETDRS letters over time • Change from baseline in BCVA by ETDRS letters after 12 months • Changes from baseline in FCP retinal thickness and FCS retinal thickness over time • Percentage of patients with active CNV leakage at Month 6 and Month 12 • Percentage of patients with fluid-free macula at each visit • Change from baseline in total lesion area at Month 6 and Month 12 • Systemic ranibizumab concentrations close to Cmax and trough levels • Change from baseline in vision-related functioning and well-being measured by NEI VFQ-25 at Month 6 and Month 12 • Number of patients with anti-ranibizumab antibodies over time | — |
Countries
Austria, Czech Republic, France, Germany, Hungary, Israel, Italy, Poland, Russian Federation, Spain, Ukraine, United Kingdom
Contacts
Public ContactClinical Trial Information Desk
Bioeq GmbH
Outcome results
None listed