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Trial record 2 of 2 for:    outlook | Wet Macular Degeneration

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03834753
Recruitment Status : Recruiting
First Posted : February 8, 2019
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Age-related Macular Degeneration Neovascular Age-related Macular Degeneration Wet Macular Degeneration Biological: bevacizumab Biological: ranibizumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : June 25, 2019
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
Experimental: bevacizumab
ONS-5010
Biological: bevacizumab
1.25 mg, intravitreal injection
Other Name: ONS-5010

Active Comparator: ranibizumab Biological: ranibizumab
0.5mg, intravitreal injection




Primary Outcome Measures :
  1. Mean change from baseline in best corrected visual acuity (BCVA) [ Time Frame: 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 :
  1. Proportion of participants who gain at least 5 letters in the best corrected visual acuity [ Time Frame: Baseline, 11 months ]
    BCVA to be assessed as letters read using the ETDRS charts. A positive change represents an improvement in visual acuity.

  2. Proportion of participants who gain at least 10 letters in the best corrected visual acuity [ Time Frame: Baseline, 11 months ]
    BCVA to be assessed as letters read using the ETDRS charts. A positive change represents an improvement in visual acuity.

  3. Proportion of participants who gain at least 15 letters in the best corrected visual acuity [ Time Frame: Baseline, 11 months ]
    BCVA to be assessed as letters read using the ETDRS charts. A positive change represents an improvement in visual acuity.

  4. Mean change in the best corrected visual acuity over time [ Time Frame: 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.

  5. Proportion of participants who lose fewer than 15 letters in the best corrected visual acuity [ Time Frame: Baseline, 11 months ]
    BCVA to be assessed as letters read using the ETDRS charts. A negative change represents a decrease in visual acuity.

  6. Proportion of participants with visual-acuity Snellen equivalent of 20/200 or worse [ Time Frame: Baseline, 11 months ]
  7. Percentage of participants with ocular adverse events, non-ocular adverse events, grade 3 and above laboratory abnormalities, and vital sign abnormalities [ Time Frame: 11 months, 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03834753


Contacts
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Contact: Clinical Operations +1 (609) 619-3984 ClinicalStudies@outlooktherapeutics.com
Contact: GreenLight Clinical +61 2 9191 0640

Locations
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United States, Arizona
Clinical Site Recruiting
Tucson, Arizona, United States, 85710
United States, California
Clinical Site Recruiting
Arcadia, California, United States, 91007
Clinical Site Recruiting
Beverly Hills, California, United States, 90211
Clinical Site Recruiting
Campbell, California, United States, 95008
Clinical Site Recruiting
Glendale, California, United States, 91203
Clinical Site Recruiting
Laguna Hills, California, United States, 92653
Clinical Site Recruiting
Mountain View, California, United States, 94040
Clinical Site Recruiting
Oxnard, California, United States, 93036
Clinical Site Recruiting
Palm Desert, California, United States, 92260
Clinical Site Recruiting
Poway, California, United States, 92064
Clinical Site Recruiting
Sacramento, California, United States, 95841
Clinical Site Recruiting
Santa Maria, California, United States, 93454
Clinical Site Recruiting
Tustin, California, United States, 92780
United States, Colorado
Clinical Site Recruiting
Golden, Colorado, United States, 80401
United States, Connecticut
Clinical Site Recruiting
Hamden, Connecticut, United States, 06518
United States, Florida
Clinical Site Recruiting
Clearwater, Florida, United States, 33761
Clinical Site Recruiting
Pinellas Park, Florida, United States, 33782
Clinical Site Recruiting
Sarasota, Florida, United States, 24233
Clinical Site Recruiting
Winter Haven, Florida, United States, 33880
United States, Georgia
Clinical Site Recruiting
Augusta, Georgia, United States, 30909
Clinical Site Recruiting
Marietta, Georgia, United States, 30060
United States, Illinois
Clinical Site Recruiting
Downers Grove, Illinois, United States, 60615
Clinical Site Recruiting
Lemont, Illinois, United States, 60439
Clinical Site Recruiting
Springfield, Illinois, United States, 62704
United States, Indiana
Clinical Site Recruiting
Indianapolis, Indiana, United States, 46290
United States, Maryland
Clinical Site Recruiting
Hagerstown, Maryland, United States, 21740
United States, Minnesota
Clinical Site Recruiting
Edina, Minnesota, United States, 55435
United States, Missouri
Clinical Site Recruiting
Saint Louis, Missouri, United States, 63144
United States, New Jersey
Clinical Site Recruiting
Bloomfield, New Jersey, United States, 07003
United States, New Mexico
Clinical Site Recruiting
Albuquerque, New Mexico, United States, 87109
United States, Pennsylvania
Clinical Site Recruiting
Monroeville, Pennsylvania, United States, 15146
United States, South Dakota
Clinical Site Recruiting
Rapid City, South Dakota, United States, 57701
United States, Tennessee
Clinical Site Recruiting
Germantown, Tennessee, United States, 38138
United States, Texas
Clinical Site Recruiting
Abilene, Texas, United States, 79606
Clinical Site Recruiting
Amarillo, Texas, United States, 79106
Clinical Site Recruiting
Arlington, Texas, United States, 76012
Clinical Site Recruiting
Dallas, Texas, United States, 75231
Clinical Site Recruiting
Grapevine, Texas, United States, 76051
Clinical Site Recruiting
Houston, Texas, United States, 77030
Clinical Site Recruiting
McAllen, Texas, United States, 78503
Clinical Site Recruiting
San Antonio, Texas, United States, 78240
Clinical Site Recruiting
San Antonio, Texas, United States, 78251
Clinical Site Recruiting
The Woodlands, Texas, United States, 77384
United States, Utah
Clinical Site Recruiting
Salt Lake City, Utah, United States, 84107
United States, Virginia
Clinical Site Recruiting
Norfolk, Virginia, United States, 23502
United States, Wisconsin
Clinical Site Recruiting
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
Outlook Therapeutics, Inc.
Investigators
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Study Director: Jennifer M Kissner, PhD Outlook Therapeutics, Inc.

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Responsible Party: Outlook Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03834753    
Other Study ID Numbers: ONS-5010-002
First Posted: February 8, 2019    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data will not be shared until all global regulatory filings are complete.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Outlook Therapeutics, Inc.:
Subfoveal Choroidal Neovascularization
Additional relevant MeSH terms:
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Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Choroidal Neovascularization
Retinal Diseases
Eye Diseases
Choroid Diseases
Uveal Diseases
Neovascularization, Pathologic
Metaplasia
Pathologic Processes
Bevacizumab
Ranibizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors