CClinicalTrials.gg
CompletedNCT04516278Updated Jul 17, 2026Results posted

A 3-month Study to Assess the Safety of ONS-5010 in Subjects With Visual Impairment Due to Retinal Disorders

A Phase 3 interventional study of bevacizumab in Age-related Macular Degeneration, Neovascular Age-related Macular Degeneration and Wet Macular Degeneration, sponsored by Outlook Therapeutics, Inc.. Completed at 20 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-17.

Sponsored by Outlook Therapeutics, Inc. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
197
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The study will evaluate the safety of ophthalmic bevacizumab in subjects diagnosed with a retinal condition that would benefit from treatment with intravitreal injection of bevacizumab, including: exudative age-related macular degeneration, diabetic macular edema, or branch retinal vein occlusion.

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Conditions studied

  • Age-related Macular Degeneration
  • Neovascular Age-related Macular Degeneration
  • Wet Macular Degeneration
  • BRVO - Branch Retinal Vein Occlusion
  • Diabetic Macular Edema
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In context

Macular Degeneration

1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.

This study's enrollment of 197 is above the median of 51 across 985 interventional studies indexed under Macular Degeneration.

Browse Macular Degeneration studies →

Lead sponsor

Outlook Therapeutics, Inc. is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Active clinical diagnosis and OCT confirmation of one of the following retinal disorders: exudative age-related macular degeneration (AMD), diabetic macular edema (DME), or branch retinal vein occlusion (BRVO) and, in the opinion of the Investigator, requires treatment with an anti-VEGF therapy

Exclusion criteria

Exclusion Criteria:

  • Previous use of approved anti-VEGF or Avastin® within 4 weeks preceding randomization
  • Macular edema due to something other than exudative AMD, DME or BRVO, in the study eye
  • History of inadequate response to previous intravitreal anti-VEGF therapy
  • History of any intraocular or periocular corticosteroid injection or implant, 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 during the study period
  • Active intraocular inflammation in the study eye
  • Current vitreous hemorrhage in the study eye
  • Polypoidal choroidal vasculopathy (PCV) in the study eye
  • History of idiopathic, infectious or autoimmune-associated uveitis in either eye
  • Current ocular or periocular infection, such as 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 , not amenable to treatment
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
197 participants (actual)

Study arms

  • Experimental
    Biological: bevacizumab

    ONS-5010

    Biological: bevacizumab

Interventions

  • Biologicalbevacizumab

    1.25 mg, intravitreal injection

    Also known as: ONS-5010

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What researchers measure

Primary outcomes

  1. Number of Participants With Adverse Events

    Number of participants with adverse events

    Time frame: 3 months

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Results

Posted Jul 17, 2026

Participant flow

Participant flow — Overall Study
MilestoneBiological: Bevacizumab
Started197
Completed192
Not completed5

Outcome measures

PrimaryNumber of Participants With Adverse Events

Number of participants with adverse events

Time frame:
3 months
Reported as:
Count of participants · Participants
Number of Participants With Adverse Events
ParticipantsBiological: Bevacizumab
Number of Participants With Adverse Events62

Adverse events

Collected over from enrollment until end of follow-up, up to 12 weeks. Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Biological: Bevacizumab1/197 (0.5%)11/197 (5.6%)23/197 (11.7%)
Most frequent serious events
Showing 10 of 16
Most frequent serious events
EventBiological: Bevacizumab
AnemiaBlood and lymphatic system disorders1/197
Acute myocardial infarctionCardiac disorders1/197
Atrioventricular block completeCardiac disorders1/197
Cardiac failure acuteCardiac disorders1/197
Cardiac failure congestiveCardiac disorders1/197
Cardiogenic shockCardiac disorders1/197
Ischemic cardiomyopathyCardiac disorders1/197
Myocardial infarctionCardiac disorders1/197
Retinal hemorrhageEye disorders1/197
Chronic kidney diseaseRenal and urinary disorders1/197
Most frequent other events
Most frequent other events
EventBiological: Bevacizumab
Urinary tract infectionInfections and infestations8/197
COVID-19Infections and infestations7/197
Conjunctival haemorrhageEye disorders4/197
FallInjury, poisoning and procedural complications4/197

Baseline characteristics

Age, Customized
Age, Customized(years)Biological: Bevacizumab
Age at Screening66.2 ± 13.47
Sex: Female, Male
Sex: Female, Male(Participants)Biological: Bevacizumab
Female110
Male87
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Biological: Bevacizumab
American Indian or Alaska Native0
Asian4
Native Hawaiian or Other Pacific Islander0
Black or African American7
White175
More than one race0
Unknown or Not Reported11
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Study locations

20 sites
  • Clinical Site
    Tucson, Arizona 85710, United States
  • Clinical Site
    Beverly Hills, California 90211, United States
  • Clinical Site
    Glendale, California 91203, United States
  • Clinical Site
    Long Beach, California 90807, United States
  • Clinical Site
    Palm Desert, California 92260, United States
  • Clinical Site
    Poway, California 92064, United States
  • Clinical Site
    Clearwater, Florida 33761, United States
  • Clinical Site
    Winter Haven, Florida 33880, United States
  • Clinical Site
    Oak Forest, Illinois 60452, United States
  • Clinical Site
    Springfield, Illinois 62704, United States
  • Clinical Site
    Hagerstown, Maryland 21740, United States
  • Clinical Site
    Albuquerque, New Mexico 87109, United States
  • Clinical Site
    Chambersburg, Pennsylvania 17201, United States
  • Clinical Site
    Rapid City, South Dakota 57701, United States
  • Clinical Site
    Germantown, Tennessee 38138, United States
  • Clinical Site
    Abilene, Texas 79606, United States
  • Clinical Site
    Arlington, Texas 76012, United States
  • Clinical Site
    McAllen, Texas 78503, United States
  • Clinical Site
    San Antonio, Texas 78251, United States
  • Clinical Site
    Willow Park, Texas 76087, United States
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References and documents

Study documents

  • Protocol and statistical analysis plan · Jul 28, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04516278
Lead sponsor
Outlook Therapeutics, Inc.
Responsible party
Sponsor
First posted
Aug 18, 2020
Start date
Oct 1, 2020
Primary completion
Feb 10, 2021
Completion
Feb 10, 2021
Results posted
Jul 17, 2026
Last update
Jul 17, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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