Efficacy and Safety of the Biosimilar Ranibizumab FYB201 in Comparison to Lucentis in Patients With Neovascular Age-related Macular Degeneration
- Conditions
- Age-related Macular Degeneration (AMD)
- Interventions
- Biological: ranibizumab
- Registration Number
- NCT02611778
- Lead Sponsor
- Bioeq GmbH
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 712
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description FYB201 ranibizumab FYB201 is provided as single use vials and will be administered by intra-vitreal injection. Lucentis ranibizumab Lucentis® is provided as single use vials and will be administered by intra-vitreal injection.
- Primary Outcome Measures
Name Time Method Change From Baseline in Best Corrected Visual Acuity (BCVA) [Letters] After 8 Weeks 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
Name Time Method Change From Baseline in Best Corrected Visual Acuity (BCVA) [Letters] After 24 Weeks 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 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 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 Baseline and Week 24 Absolute change in Foveal Centre Point (FCP) retinal thickness \[µm\] from baseline to Week 24
Change in NEI VFQ-25 Composite Score From Baseline to Week 24 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.Fluid-free Macula at Each Visit 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 Pre- and Post-first Dosing 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).
Change in Foveal Centre Point (FCP) Retinal Thickness From Baseline to Week 48 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 Baseline and Week 24 Absolute change in Foveal Central Subfield (FCS) retinal thickness \[µm\] from baseline to Week 24
Change in Total Lesion Area From Baseline to Week 48 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 48 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 Baseline and Week 24 Number and percentage of patients with active CNV leakage at Week 24
Active CNV Leakage at Week 48 Baseline and Week 48 Number and percentage of patients with active CNV leakage at Week 48
Change in Foveal Central Subfield (FCS) Retinal Thickness From Baseline to Week 48 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 Baseline and Week 24 Absolute change in total lesion area \[mm²\] from baseline to Week 24
Anti-drug Antibodies by Scheduled eCRF Visit Baseline and Weeks 1, 4, 12, 24, 48 Frequency of patients with anti-drug antibodies (ADAs) by scheduled eCRF visit
Trial Locations
- Locations (2)
Research Site
🇬🇧Rugby, United Kingdom
University of Bonn, Department of Ophthalmology
🇩🇪Bonn, Germany