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

Phase 3

Completed

• Conditions: Neovascular Age-related Macular Degeneration; Wet Macular Degeneration; Age-related Macular Degeneration
• Interventions: Biological: bevacizumab; Biological: ranibizumab

• Registration Number: NCT03844074
• Lead Sponsor: Outlook Therapeutics, Inc.

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 ranibizumab.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-01
• Study First Submitted: 2019-02-14
• Study First Submitted QC: 2019-02-14
• Study First Posted: 2019-02-18
• Primary Completion: 2020-07-23
• Study Completion: 2020-08-13
• Status Verified: 2021-05
• Disposition First Submitted: 2021-05-04
• Disposition First Submitted QC: 2021-05-04
• Disposition First Posted: 2021-05-07
• Last Update Submitted: 2021-05-07
• Last Update Posted: 2021-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bevacizumab	bevacizumab	ONS-5010
ranibizumab	ranibizumab	-

Primary Outcome Measures

Name	Time	Method
Proportion of subjects who gain 15 or more letters in the best corrected visual acuity (BCVA) score	Baseline, 11 months	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.

Secondary Outcome Measures

Name	Time	Method
Proportion of participants who lose fewer than 15 letters in the best corrected visual acuity score	Baseline, 11 months	BCVA to be assessed as letters read using the ETDRS charts. A negative change represents a decrease in visual acuity.
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
Proportion of participants who gain at least 5 letters in the best corrected visual acuity score	Baseline, 11 months	BCVA to be assessed as letters read using the ETDRS charts. A positive change represents an improvement in visual acuity.
Mean change in the best corrected visual acuity over time	Baseline, monthly to 11 months	BCVA to be assessed as letters read using the ETDRS charts. A positive change represents an improvement in visual acuity.
Proportion of participants who gain at least 10 letters in the best corrected visual acuity score	Baseline, 11 months	BCVA to be assessed as letters read using the ETDRS charts. A positive change represents an improvement in visual acuity.

Trial Locations

Locations (1)

Clinical Site; 🇦🇺 Glen Waverley, Victoria, Australia