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

NCT03834753 | Completed Phase 3 FDA Drug

• 1 other identifier: ONS-5010-002
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 50

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.

Conditions

Age-related Macular Degeneration; Neovascular Age-related Macular Degeneration; Wet Macular Degeneration

Keywords

Subfoveal Choroidal Neovascularization

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects who gain 15 or more letters in best corrected visual acuity (BCVA)

  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 Outcomes (6)

• Mean change in the best corrected visual acuity

  Baseline, monthly to 11 months

• Proportion of participants who gain at least 10 letters in the best corrected visual acuity

  Baseline, 11 months

• Proportion of participants who gain at least 5 letters in the best corrected visual acuity

  Baseline, 11 months

• Proportion of participants who lose fewer than 15 letters in the best corrected visual acuity

  Baseline, 11 months

• Proportion of participants with visual-acuity Snellen equivalent of 20/200 or worse

  Baseline, 11 months

Study Arms (2)

bevacizumab

EXPERIMENTAL

ONS-5010

Biological: bevacizumab

ranibizumab

ACTIVE COMPARATOR

Biological: ranibizumab

Interventions

bevacizumab BIOLOGICAL

1.25 mg, intravitreal injection

Also known as: ONS-5010

bevacizumab

ranibizumab BIOLOGICAL

0.5mg, intravitreal injection

ranibizumab

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Outlook Therapeutics, Inc.: lead

Study Sites (50)

Clinical Site

Tucson, Arizona, 85710, United States

Location

Clinical Site

Arcadia, California, 91007, United States

Location

Clinical Site

Beverly Hills, California, 90211, United States

Location

Clinical Site

Campbell, California, 95008, United States

Location

Clinical Site

Glendale, California, 91203, United States

Location

Clinical Site

Laguna Hills, California, 92653, United States

Location

Clinical Site

Long Beach, California, 90807, United States

Location

Clinical Site

Mountain View, California, 94040, United States

Location

Clinical Site

Oxnard, California, 93036, United States

Location

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Palm Desert, California, 92260, United States

Location

Clinical Site

Poway, California, 92064, United States

Location

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Sacramento, California, 95841, United States

Location

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Santa Maria, California, 93454, United States

Location

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Tustin, California, 92780, United States

Location

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Golden, Colorado, 80401, United States

Location

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Hamden, Connecticut, 06518, United States

Location

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Clearwater, Florida, 33761, United States

Location

Clinical Site

Pinellas Park, Florida, 33782, United States

Location

Clinical Site

Sarasota, Florida, 24233, United States

Location

Clinical Site

Winter Haven, Florida, 33880, United States

Location

Clinical Site

Augusta, Georgia, 30909, United States

Location

Clinical Site

Marietta, Georgia, 30060, United States

Location

Clinical Site

Downers Grove, Illinois, 60615, United States

Location

Clinical Site

Lemont, Illinois, 60439, United States

Location

Clinical Site

Springfield, Illinois, 62704, United States

Location

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Indianapolis, Indiana, 46290, United States

Location

Clinical Site

Hagerstown, Maryland, 21740, United States

Location

Clinical Site

Edina, Minnesota, 55435, United States

Location

Clinical Site

St Louis, Missouri, 63144, United States

Location

Clinical Site

Bloomfield, New Jersey, 07003, United States

Location

Clinical Site

Albuquerque, New Mexico, 87109, United States

Location

Clinical Site

New York, New York, 10021, United States

Location

Clinical Site

Chambersburg, Pennsylvania, 17201, United States

Location

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Monroeville, Pennsylvania, 15146, United States

Location

Clinical Site

Rapid City, South Dakota, 57701, United States

Location

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Germantown, Tennessee, 38138, United States

Location

Clinical Site

Abilene, Texas, 79606, United States

Location

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Amarillo, Texas, 79106, United States

Location

Clinical Site

Arlington, Texas, 76012, United States

Location

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Dallas, Texas, 75231, United States

Location

Clinical Site

Grapevine, Texas, 76051, United States

Location

Clinical Site

Houston, Texas, 77030, United States

Location

Clinical Site

McAllen, Texas, 78503, United States

Location

Clinical Site

San Antonio, Texas, 78240, United States

Location

Clinical Site

San Antonio, Texas, 78251, United States

Location

Clinical Site

The Woodlands, Texas, 77384, United States

Location

Clinical Site

Willow Park, Texas, 76807, United States

Location

Clinical Site

Salt Lake City, Utah, 84107, United States

Location

Clinical Site

Norfolk, Virginia, 23502, United States

Location

Clinical Site

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Macular Degeneration; Wet Macular Degeneration

Interventions

Bevacizumab; Ranibizumab

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Jennifer M Kissner, PhD

  Outlook Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2019
• First Posted: February 8, 2019
• Study Start: June 25, 2019
• Primary Completion: June 7, 2021
• Study Completion: July 8, 2021
• Last Updated: March 19, 2025

Record last verified: 2025-03

Locations

US (50)