This research study will examine the safety and effectiveness of ONS-5010 in participants with AMD. The goal is to prevent vision loss by evaluating the effectiveness of ONS-5010 as compared with ranibizumab.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
61
1.25 mg, intravitreal injection
0.5mg, intravitreal injection
Clinical Site
Hurstville, New South Wales, Australia
Clinical Site
Liverpool, New South Wales, Australia
Clinical Site
Sydney, New South Wales, Australia
Clinical Site
Westmead, New South Wales, Australia
Proportion of subjects who gain 15 or more letters in the best corrected visual acuity (BCVA) score
BCVA to be assessed as letters read using the Early Treatment Diabetic Retinopathy Study (ETDRS) charts. A positive change represents an improvement in visual acuity.
Time frame: Baseline, 11 months
Mean change in the best corrected visual acuity over time
BCVA to be assessed as letters read using the ETDRS charts. A positive change represents an improvement in visual acuity.
Time frame: Baseline, monthly to 11 months
Proportion of participants who gain at least 10 letters in the best corrected visual acuity score
BCVA to be assessed as letters read using the ETDRS charts. A positive change represents an improvement in visual acuity.
Time frame: Baseline, 11 months
Proportion of participants who gain at least 5 letters in the best corrected visual acuity score
BCVA to be assessed as letters read using the ETDRS charts. A positive change represents an improvement in visual acuity.
Time frame: Baseline, 11 months
Proportion of participants who lose fewer than 15 letters in the best corrected visual acuity score
BCVA to be assessed as letters read using the ETDRS charts. A negative change represents a decrease in visual acuity.
Time frame: Baseline, 11 months
Proportion of participants with visual-acuity Snellen equivalent of 20/200 or worse
Time frame: Baseline, 11 months
Percentage of participants with ocular adverse events, non-ocular adverse events, grade 3 and above laboratory abnormalities, and vital sign abnormalities
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Clinical Site
Brisbane, Queensland, Australia
Clinical Site
Adelaide, South Australia, Australia
Clinical Site
Hobart, Tasmania, Australia
Clinical Site
Essendon, Victoria, Australia
Clinical Site
Glen Waverley, Victoria, Australia
Time frame: 11 months, 12 months