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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03844074
• Other study ID #: ONS-5010-001
• Status: Completed
• Phase: Phase 3
• Start date: October 1, 2018
• Est. completion date: August 13, 2020

Study information

• Verified date: May 2021
• Source: Outlook Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 ranibizumab.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Age-related Macular Degeneration
• Choroidal Neovascularization
• Macular Degeneration
• Neovascular Age-related Macular Degeneration
• Wet Macular Degeneration

Intervention

Biological:
• bevacizumab
1.25 mg, intravitreal injection
• ranibizumab
0.5mg, intravitreal injection

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Outlook Therapeutics, Inc.

Country where clinical trial is conducted

Australia, 

Outcome

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