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

COMPLETEDPHASE3

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

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

NCT03834753•Outlook Therapeutics, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

50 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Active primary Subfoveal Choroidal Neovascularization lesions secondary to Age-related macular degeneration (AMD) in the study eye
•Best corrected visual acuity of 25-67 letters read (20/50 to 20/320 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 haemorrhage 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
+2 more criteria

Locations (50)

Clinical Site

Tucson, Arizona, United States

Clinical Site

Arcadia, California, United States

Clinical Site

Beverly Hills, California, United States

Clinical Site

Campbell, California, United States

Clinical Site

Glendale, California, United States

Clinical Site

Laguna Hills, California, United States

Clinical Site

Long Beach, California, United States

Clinical Site

Mountain View, California, United States

Clinical Site

Oxnard, California, United States

Clinical Site

Palm Desert, California, United States

Key Dates

Start Date

June 25, 2019

Primary Completion Date

June 7, 2021

Completion Date

July 8, 2021

Last Updated

March 19, 2025

Enrollment

228

ACTUAL participants

Conditions

Age-related Macular DegenerationNeovascular Age-related Macular DegenerationWet Macular Degeneration

Interventions

bevacizumab

BIOLOGICAL

ranibizumab

BIOLOGICAL

Direct Discrimination of Quantum States by the Human Eye

NCT05913063

Age-Related Macular Degeneration

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RECRUITINGPHASE2

Phase 2 Study of ADX-038 in Participants With Geographic Atrophy

NCT06990269

Geographic Atrophy Secondary to Age-related Macular Degeneration

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RECRUITINGPHASE4

A Study About the Safety of ASP3021 Eye Injections and if They Help People in Japan With Vision Loss From Age-related Macular Degeneration

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 19, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Direct Discrimination of Quantum States by the Human Eye

Phase 2 Study of ADX-038 in Participants With Geographic Atrophy

A Study About the Safety of ASP3021 Eye Injections and if They Help People in Japan With Vision Loss From Age-related Macular Degeneration

Study to Assess the Adverse Events and How Intravitreal ABBV-6628 Moves Through the Body of Adult Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration

A Phase IIb Randomized, Multicenter Trial of Subretinal CPCB-RPE1 in Advanced Dry AMD (Geographic Atrophy)

A Study of the Efficacy, Safety, and Pharmacokinetics (PK) of the Port Delivery System With Ranibizumab (PDS) in Chinese Participants With Neovascular Age-related Macular Degeneration (nAMD)