A 3-month Study to Assess the Safety and Effectiveness of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD)

Phase 3

Completed

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

• Registration Number: NCT06190093
• Lead Sponsor: Outlook Therapeutics, Inc.

Brief Summary

Multicenter, randomized, masked, controlled study of the safety and effectiveness of intravitreally administered ONS-5010.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-19
• Study First Submitted QC: 2023-12-19
• Study First Posted: 2024-01-05
• Study Start: 2024-01-24
• Primary Completion: 2024-11-07
• Study Completion: 2024-12-05
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Active primary Subfoveal Choroidal Neovascularization lesions secondary to Age-related macular degeneration (AMD) in the study eye
• Best corrected visual acuity of 35-75 letters read (20/32 to 20/200 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 hemorrhage 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ONS-5010 bevacizumab	bevacizumab	-
ranibizumab	ranibizumab	-

Primary Outcome Measures

Name	Time	Method
Evaluate the effectiveness of intravitreal injections of ONS-5010 compared to ranibizumab in preventing vision loss, as measured by the mean change in baseline best correct visual acuity (BCVA) at Week 8	Baseline, 8 weeks	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.

Trial Locations

Locations (1)

Clinical Site; 🇺🇸 Silverdale, Washington, United States