Age-related Macular Degeneration Clinical Trial
Official title:
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
Verified date | May 2021 |
Source | Outlook Therapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 61 |
Est. completion date | August 13, 2020 |
Est. primary completion date | July 23, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility | Inclusion Criteria: - Active primary or recurrent Subfoveal Choroidal Neovascularization lesions secondary to Age-related macular degeneration (AMD) in the study eye - Best corrected visual acuity of 20/40 to 20/320 - Study eye must: - Have active leakage on Fluorescein Angiogram involving the fovea - Have edema involving the fovea - Be free of foveal scarring - Be free of foveal atrophy Exclusion Criteria: - Previous use of anti-VEGF or bevacizumab within 6 weeks - 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) confirmed by indocyanine green angiography (ICGA) - 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 or indocyanine green, not amenable to treatment |
Country | Name | City | State |
---|---|---|---|
Australia | Clinical Site | Adelaide | South Australia |
Australia | Clinical Site | Brisbane | Queensland |
Australia | Clinical Site | Essendon | Victoria |
Australia | Clinical Site | Glen Waverley | Victoria |
Australia | Clinical Site | Hobart | Tasmania |
Australia | 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 |
Lead Sponsor | Collaborator |
---|---|
Outlook Therapeutics, Inc. |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Baseline, 11 months | |
Secondary | 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. | Baseline, monthly to 11 months | |
Secondary | 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. | Baseline, 11 months | |
Secondary | 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. | Baseline, 11 months | |
Secondary | 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. | Baseline, 11 months | |
Secondary | Proportion of participants with visual-acuity Snellen equivalent of 20/200 or worse | Baseline, 11 months | ||
Secondary | 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 |
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