This is a phase 2 randomized, double -masked study comparing the efficacy of EYP-1901 at 2 dose levels: 2060 microgram (mcg) and 3090 mcg against aflibercept.
This study is evaluating the 2 doses of EYP-1901 against aflibercept in a randomized study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
161
Intravitreal Injection
Intravitreal Injection
Average Change in Best Corrected Visual Acuity (BCVA) From Baseline Averaged Over Weeks 28 and 32
The BCVA was measured according to the standard procedure originally developed for Early Treatment Diabetic Retinopathy Study (ETDRS). The ETDRS letter score calculated when 20 or more letters were read correctly at 4.0 meters; the visual acuity letter score was equal to the total number of letters read correctly at 4.0 meters plus 30. The score ranges from 0 (worse) to 100 (best). Higher scores indicate positive outcome measure. Baseline was defined as the last non-missing measurement before the initiation of study treatment.
Time frame: Baseline (Day 1) and Weeks 28 and 32
Change From Baseline in Best Corrected Visual Acuity up to Week 56
The BCVA was measured according to the standard procedure originally developed for ETDRS. The ETDRS letter score calculated when 20 or more letters were read correctly at 4.0 meters; the visual acuity letter score was equal to the total number of letters read correctly at 4.0 meters plus 30. The score ranges from 0 (worse) to 100 (best). Higher scores indicate positive outcome measure. Baseline was defined as the last non-missing measurement before the initiation of study treatment.
Time frame: Baseline (Day 1) and Weeks 32 and 56
Percentage of Subjects With >=5, >=10, and >=15 BCVA Letter Change From Baseline up to Week 56
The BCVA was measured according to the standard procedure originally developed for ETDRS. The ETDRS letter score calculated when 20 or more letters were read correctly at 4.0 meters; the visual acuity letter score was equal to the total number of letters read correctly at 4.0 meters plus 30. The score ranges from 0 (worse) to 100 (best). Higher scores indicate positive outcome measure. Baseline was defined as the last non-missing measurement before the initiation of study treatment.
Time frame: Baseline (Day 1) and Weeks 32 and 56
Percentage of Subjects Not Receiving Supplemental Injection of Aflibercept up to Week 56
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Supplemental therapy was any unscheduled injection of aflibercept, whether or not a subject had met rescue criteria. For the aflibercept arm, any aflibercept injection following Week 8 which did not occur at Weeks 16, 24, 32, 40, 48, or 56, was supplemental therapy. For either of the EYP-1901 arms, any aflibercept injection following the Week 8 visit was supplemental therapy.
Time frame: Weeks 32 and 56
Median Time to First Supplemental Aflibercept Injection in the Study Eye Following the EYP-1901 Dose at Week 8
Time to first supplemental aflibercept injection following Week 8 study treatment was defined as the date of the first supplemental aflibercept injection minus the date of the Week 8 study treatment administration, divided by 7 days per week. Subjects who did not receive any supplemental aflibercept injection following study treatment administration at Week 8 were censored at their date of last visit (those who completed) or date of last contact (those who discontinued the study early).
Time frame: From Week 8 to Week 56
Number of Aflibercept Intravitreal Injections up to Week 56 (Including Loading Dose)
Normalized number of aflibercept injections including loading dose was calculated as (number of aflibercept injections received plus all loading doses received) / (time within study period in months), multiplied by 6 months (Week 32) or 12 months (Week 56).
Time frame: Weeks 32 and 56
Mean Change From Baseline in Central Subfield Thickness (CST) by Spectral-Domain - Optical Coherence Tomography (SD-OCT) up to Week 56
The SD-OCT assessments in study eye was taken by a study-certified OCT technician according to the standardized procedures described in the Study Manual. Baseline was defined as the last non-missing measurement before the initiation of study treatment.
Time frame: Baseline (Day 1) and Weeks 32 and 56
Change From Baseline in Height of Subretinal Fluid by Spectral-Domain - Optical Coherence Tomography up to Week 56
The SD-OCT assessments in study eye was taken by a study-certified OCT technician according to the standardized procedures described in the Study Manual. Baseline was defined as the last non-missing measurement before the initiation of study treatment.
Time frame: Baseline (Day 1) and Weeks 32 and 56
Percentage of Subjects With No Detectable Intraretinal Fluid/Cysts in the Central Subfield up to Week 56
The percentage of subjects with no detectable intraretinal fluid/cysts in the central subfield were summarized by scheduled visit and for any time post-baseline visits. Intraretinal fluid was assessed for the categories 'Absent', 'Present, not clinically significant', 'Present, clinically significant' and 'Not Done'. If intraretinal fluid assessment at any scheduled visit fell under the category 'Absent or Present, not clinically significant', then it was considered as no detectable intraretinal fluid in that scheduled visit.
Time frame: Weeks 32 and 56
Change From Baseline in Total Lesion Area by Fluorescein Angiography (FA) up to Week 56
The total lesion area was defined as the active vascular component \[classic and occult choroidal neovascularization (CNV)\] and the non-vascular/fibrotic component (fibrosis, serous pigment epithelial detachment, elevated blocking hemorrhage or hyperplastic pigment). Baseline was defined as the last non-missing measurement before the initiation of study treatment.
Time frame: Baseline (Day 1) and Weeks 32 and 56
Change From Baseline in Total Choroidal Neovascularization Area by Fluorescein Angiography up to Week 56
The total CNV area included the measured area of classic and occult components. Baseline was defined as the last non-missing measurement before the initiation of study treatment.
Time frame: Baseline (Day 1) and Weeks 32 and 56
Systemic Exposure to EYP-1901 Measured Through Plasma Levels up to Week 56
Blood samples were collected at the study visits to determine the EYP-1901 and its main metabolite concentrations.
Time frame: Up to Week 56
Ocular Exposure to EYP-1901 Measured Through Aqueous Humor (AH) Levels up to Week 32
The AH samples were collected at the study visits to determine the EYP-1901 and its main metabolite concentrations.
Time frame: Up to Week 32
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Serious Treatment-Emergent Adverse Events up to Week 56
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a patient or clinical investigation subject administered an investigational or marketed (medicinal) product and that does not necessarily have a causal relationship with the product. An serious AE is any AE that results in one of the following outcomes: death; life-threatening; requires in-patient hospitalization; results in a persistent or significant disability/incapacity; congenital anomaly/birth defect; other important medical event. The TEAEs are AEs that occur after the first dose of study treatment. administration.
Time frame: From the study drug administration (Day 1) up to end of the study, approximately 56 weeks.