This is a randomized, double-masked, multicenter study to evaluate the efficacy and safety of FYB203 compared to Eylea® in patients with neovascular age related macular degeneration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
434
Patients will receive 1 IVT injection of FYB203 in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.
Patients will receive 1 IVT injection of Eylea® in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.
Evaluate and Compare Functional Changes in Best Corrected Visual Acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) Letters at Week 8 of Treatment With FYB203 or Eylea Compared to Baseline.
Changes in Best Corrected Visual Acuity (BCVA) by ETDRS letters from the Baseline Visit (Visit 1) to Week 8 (Visit 3) were assessed. This involved measuring the number of letters a participant could correctly read using the study eye on the ETDRS chart. An increase in the number of ETDRS letters from baseline signifies an improvement in visual acuity of the study eye. The change from baseline was calculated as the observed post-baseline value minus the baseline value.
Time frame: Week 8
Evaluate and Compare Functional Changes of the Retina by BCVA Over Time
Change of BCVA by ETDRS letters over the whole study from Baseline Visit (Visit 1) to Week 24 (Visit 5) and Week 56 (Visit 9) - FAS
Time frame: Through study completion, until Week 56 (Visit 9)
Evaluate and Compare Changes in Foveal Center Point (FCP) Retinal Thickness
Change from Baseline Visit (Visit 1) in foveal center point FCP retinal thickness to Week 4 (Visit 2), Week 24 (Visit 5) and Week 56 (Visit 9) - FAS
Time frame: Through study completion, until Week 56 (Visit 9)
Evaluate and Compare the Proportion of Patients Who Gain or Lose ≥ 5, 10, and 15 Early Treatment Diabetic Retinopathy Study (ETDRS) Letters Compared to Baseline
Proportion of patients who gain or lose ≥ 5, 10, or 15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters from Baseline Visit (Visit 1) to Week 24 (Visit 5) and Week 56 (Visit 9) - FAS
Time frame: Through study completion, until Week 56 (Week 9)
Evaluate and Compare the Absence of Disease Activity (Fluid-free Macula) Over Time
Percentage of patients with fluid-free macula at Baseline (Visit 1), Week 24 (Visit 5), Week 56 (Visit 9) - FAS
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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
...and 56 more locations
Time frame: Through study completion, until Week 56 (Visit 9)
Evaluate and Compare Systemic Free Aflibercept Concentrations in a Subgroup of up to 60 Patients (up to 30 Per Arm)
Systemic concentrations (close to maximum concentration \[Cmax\]) of free aflibercept in a subgroup at selected sites - PKS: \- 48 hours after the 3rd dose (Visit 3a)
Time frame: At Baseline and Visit 3a (48 hours after the 3rd dose)
Evaluate and Compare Change in Vision-related Functioning and Well-being Measured by National Eye Institute Visual Function Questionnaire 25 (NEI VFQ-25)
Change from Baseline Visit (Visit 1) in vision-related functioning and well-being measured by National Eye Institute Visual Function Questionnaire 25 (NEI VFQ-25) to Week 24 (Visit 5) and Week 56 (Visit 9) - FAS. The NEI VFQ-25 includes 12 subscales (e.g., general vision, ocular pain, driving, peripheral vision) scored from 0 to 100, where higher scores indicate better functioning. Subscales are averaged to produce a composite score, excluding the general health subscale. Both subscale and composite scores range from 0 (worst) to 100 (best), representing the percentage of the highest possible score achieved.
Time frame: Through study completion, until Week 56 (Visit 9)
Evaluate and Compare the Immunogenic Profile (Anti-drug Antibodies [ADAs]) in Serum
Number of patients with anti-drug antibodies (ADAs) at Baseline (Visit 1), Week 24 (Visit 5) and Week 56 (Visit 9) - SAF
Time frame: Through study completion, until Week 56 (Visit 9)
Frequency of Local and Systemic Adverse Events (AEs) and Serious Adverse Events (SAEs)
Frequency of local and systemic adverse events (AEs) and serious adverse events (SAEs) - SAF
Time frame: Through study completion, until Week 56 (Visit 9)