Status:
COMPLETED
A Clinical Effectiveness Study Examining the Efficacy and Safety of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD)
Lead Sponsor:
Outlook Therapeutics, Inc.
Conditions:
Age-related Macular Degeneration
Neovascular Age-related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief Summary
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 rani...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 13 2020
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT03844074
Start Date
October 1 2018
End Date
August 13 2020
Last Update
March 19 2025
Active Locations (9)
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1
Clinical Site
Hurstville, New South Wales, Australia
2
Clinical Site
Liverpool, New South Wales, Australia
3
Clinical Site
Sydney, New South Wales, Australia
4
Clinical Site
Westmead, New South Wales, Australia