A Clinical Effectiveness Study Examining the Efficacy and Safety of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD)

Study Overview
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Brief Summary
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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.

Official Title
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A Clinical Effectiveness, Multicenter, Randomized, Double-masked, Controlled Study of the Efficacy and Safety of ONS-5010 in Subjects With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration

Conditions
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Age-related Macular Degeneration, Neovascular Age-related Macular Degeneration, Wet Macular Degeneration

Intervention / Treatment
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* Biological: bevacizumab
* Biological: ranibizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Active primary Subfoveal Choroidal Neovascularization lesions secondary to Age-related macular degeneration (AMD) in the study eye Best corrected visual acuity of 25-67 letters read (20/50 to 20/320 Snellen equivalent) Study eye must: Have active leakage on Fluorescein Angiogram involving the fovea Have edema involving the fovea Be free of scarring, fibrosis, or atrophy involving the central foveal zone Exclusion Criteria: Previous subfoveal focal laser photocoagulation in the study eye Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1-month preceding randomization Any concurrent intraocular condition in the study eye that may require medical or surgical intervention or contribute to vision loss within 1 year Active intraocular inflammation (grade trace or above) in the study eye Current vitreous haemorrhage in the study eye Polypoidal choroidal vasculopathy (PCV) in the study eye History of idiopathic or autoimmune-associated uveitis in either eye Infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥30 mmHg despite treatment with anti-glaucoma medication) Premenopausal women not using adequate contraception Current treatment for active systemic infection Known allergy to any component of the study drug or history of allergy to fluorescein , not amenable to treatment

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bevacizumab<br>ONS-5010 | Biological: bevacizumab<br>* 1.25 mg, intravitreal injection<br>* Other names: ONS-5010;|
| Active Comparator: ranibizumab<br> | Biological: ranibizumab<br>* 0.5mg, intravitreal injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects who gain 15 or more letters in best corrected visual acuity (BCVA) | 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. | Baseline, 11 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in the best corrected visual acuity | BCVA to be assessed as letters read using the ETDRS charts. A positive change represents an improvement in visual acuity. | Baseline, monthly to 11 months | 
| Proportion of participants who gain at least 10 letters in the best corrected visual acuity | BCVA to be assessed as letters read using the ETDRS charts. A positive change represents an improvement in visual acuity. | Baseline, 11 months | 
| Proportion of participants who gain at least 5 letters in the best corrected visual acuity | BCVA to be assessed as letters read using the ETDRS charts. A positive change represents an improvement in visual acuity. | Baseline, 11 months | 
| Proportion of participants who lose fewer than 15 letters in the best corrected visual acuity | BCVA to be assessed as letters read using the ETDRS charts. A negative change represents a decrease in visual acuity. | Baseline, 11 months | 
| Proportion of participants with visual-acuity Snellen equivalent of 20/200 or worse |  | Baseline, 11 months | 
| Percentage of participants with ocular adverse events, non-ocular adverse events, grade 3 and above laboratory abnormalities, and vital sign abnormalities |  | 11 months, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Subfoveal Choroidal Neovascularization