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Completed

NCT Number: NCT03834753

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

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.

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Key information

Conditions

Age-Related Macular Degeneration Eye Diseases Macular Degeneration Neovascular Age-related Macular Degeneration Retinal Degeneration Retinal Diseases Wet Macular Degeneration

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinical Site, Tucson, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bevacizumab

Biological

1.25 mg, intravitreal injection

Other names: ONS-5010

ranibizumab

Biological

0.5mg, intravitreal injection

Primary outcomes

  1. Proportion of subjects who gain 15 or more letters 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 outcomes

  1. Mean change in the best corrected visual acuity

    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.

  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 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.

  4. 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.

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

    Time frame: Baseline, 11 months

  6. 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

Sponsors and collaborators

Lead sponsor

Outlook Therapeutics, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Feb 8, 2019
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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