A 2-year phase 3, multicentre, randomised, parallel-group, sham-controlled, double-masked study. Primary efficacy will be determined at Week 52.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
998
intravitreal injection
intravitreal injection
intravitreal injection
Mean Change in Early Treatment Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) Letters
To determine the efficacy of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 2.0 mg aflibercept, in participants with neovascular age-related macular degeneration (nAMD), in terms of change in ETDRS BCVA letter score in the study eye from Baseline to Week 52. The primary analysis presented used mixed model for repeated measures in the overall population. (A positive outcome measure means an improvement in ETDRS BCVA letter score from baseline; a negative outcome measure means a deterioration in ETDRS BCVA letter score from baseline)
Time frame: Baseline to Week 52
Proportion of Participants Gaining 15 or More ETDRS BCVA Letters
To determine the effects of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 2.0 mg aflibercept, in participants with neovascular age-related macular degeneration (nAMD), in terms of proportion of participants gaining 15 or more letters in ETDRS BCVA in the study eye from Baseline to Week 52. The secondary analysis presented used multiple imputation analysis assuming missing at random in the overall population.
Time frame: Baseline to Week 52
Proportion of Participants Gaining 10 or More ETDRS BCVA Letters
To determine the effects of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 2.0 mg aflibercept, in participants with neovascular age-related macular degeneration (nAMD), in terms of proportion of participants gaining 10 or more letters in ETDRS BCVA in the study eye from Baseline to Week 52. The secondary analysis presented used multiple imputation analysis assuming missing at random in the overall population.
Time frame: Baseline to Week 52
Change in Choroidal Neovascularisation (CNV) Area by Fluorescein Angiography (FA)
To determine the effects of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 2.0 mg aflibercept, in participants with neovascular age-related macular degeneration (nAMD), in terms of change in CNV area as measured by FA in the study eye from Baseline to Week 52. The secondary analysis presented used mixed model for repeated measures in the overall population.
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COAST Investigational Site
Phoenix, Arizona, United States
COAST Investigational Site
Arcadia, California, United States
COAST Investigational Site
Huntington Beach, California, United States
COAST Investigational Site
Redlands, California, United States
COAST Investigational Site
Sacramento, California, United States
COAST Investigational Site
Danbury, Connecticut, United States
COAST Investigational Site
Altamonte Springs, Florida, United States
COAST Investigational Site
Boynton Beach, Florida, United States
COAST Investigational Site
Coral Springs, Florida, United States
COAST Investigational Site
Melbourne, Florida, United States
...and 199 more locations
Time frame: Baseline to Week 52
Proportion of Participants With Absence of Both Sub-retinal Fluid and Intra-retinal Cysts by SD-OCT
To determine the effects of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 2.0 mg aflibercept, in participants with neovascular age-related macular degeneration (nAMD), in terms of proportion of participants with absence of both sub-retinal fluid and intra-retinal cysts by SD-OCT in the study eye at Week 52. The secondary analysis presented used multiple imputation analysis assuming missing at random in the overall population.
Time frame: at Week 52