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Monoclonal Antibodies

Bevacizumab Safety for Retinal Disease (NORSE SEVEN Trial)

Phase 3
Waitlist Available
Research Sponsored by Outlook Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Previous use of Beovu®
Macular edema due to something other than exudative AMD, DME or BRVO, in the study eye
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial will compare the safety of two ways to give the drug bevacizumab to people with a retinal condition.

Who is the study for?
This trial is for individuals with certain retinal disorders like wet age-related macular degeneration, diabetic macular edema, or branch retinal vein occlusion. Participants must need anti-VEGF therapy and not have used similar treatments recently. They shouldn't have other eye conditions that could affect the study or be premenopausal women without contraception.
What is being tested?
The safety of an eye medication called bevacizumab is being tested in two forms: vials and pre-filled syringes. The drug will be given through injections into the eye to people with specific vision impairments due to retinal diseases.
What are the potential side effects?
Bevacizumab may cause side effects such as redness, discomfort at the injection site, increased intraocular pressure, inflammation inside the eye, bleeding in the retina, and possibly infection.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have previously used Beovu®.
Select...
My eye swelling is not due to AMD, DME, or BRVO.
Select...
My eye condition didn't improve after receiving anti-VEGF injections.
Select...
I have never had steroid injections or implants in or around my eye.
Select...
I have an eye condition that might get worse or need treatment during the study.
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I have active inflammation in my eye.
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My study eye has polypoidal choroidal vasculopathy.
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I have had uveitis due to unknown, infectious, or autoimmune causes.
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I do not have any current eye infections.
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My eye pressure is high (≥30 mmHg) despite using glaucoma medication.
Select...
I have bleeding inside the eye being studied.
Select...
I am a premenopausal woman not using birth control.
Select...
I am currently being treated for an infection that affects my whole body.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2017 Phase 1 & 2 trial • 96 Patients • NCT01266031
100%
Headache
100%
Fatigue
83%
Lymphocyte count decreased
83%
Hemoglobin Increase
83%
Nausea
83%
Platelet count decreased
67%
Memory impairment
67%
Bicarbonate Serum-low
67%
Constipation
67%
Dizziness
67%
Gait disturbance
67%
Pyramidal Tract Dysfunction
50%
Hypoalbuminemia
50%
Hyponatremia
50%
Infection with Normal ANC (Neck NOS), (Urinary Tract NOS)
50%
METABOLIC/LABORATORY (elevated LDH)
50%
Edema limbs
50%
Leukocytosis
50%
METABOLIC/LABORATORY (Elevated BUN)
50%
Mood Alteration
50%
Speech Impairment
33%
Stomach pain
33%
Aspartate aminotransferase (AST) increased
33%
Neuropathy, Cranial (Pupil, Upper eyelid)
33%
Neuropathy, Sensory Legs/Toes tingling
33%
Taste Alteration
33%
Diplopia
33%
Muscle weakness- Whole body/generalized
33%
OCULAR/VISUAL (Right & Left visual field deficits)
33%
Hypokalemia
33%
Hypophosphatemia
33%
Alanine aminotransferase (ALT) increased
33%
Alkaline phosphatase increased
33%
Anorexia
33%
Bruising
33%
Confusion
33%
Diarrhea
33%
Gait/walking (wide based ataxic hemiparetic)
33%
Hyperglycemia
33%
Hypoglycemia
33%
METABOLIC/LABORATORY (low creatinine)
33%
METABOLIC/LABORATORY (low protein)
33%
Muscle weakness lower extremity
33%
Seizure
33%
Somnolence
17%
Dehydration
17%
DECUBITUS Ulcer Sacrum
17%
Hyperuricemia
17%
Allergic rhinitis
17%
Bloating
17%
Irregular Menses
17%
Pain (Neuropathic in perineal/buttock)
17%
Heartburn
17%
Hypocalcemia
17%
Mental Status Altered
17%
Infection with Normal ANC (Neck NOS), cellulitis
17%
METABOLIC/LABORATORY (low chloride)
17%
Mucositis oral
17%
Obstruction GI (STOMACH-small bowel nos)
17%
Epistaxis
17%
Tremor
17%
Blood bilirubin increased
17%
Blurred vision
17%
Cholesterol high
17%
Creatinine increased
17%
Cushingoid
17%
Bump at sutura site
17%
Multiple scabs
17%
Dysphagia
17%
Edema cerebral
17%
Gait/walking Impaired mobility
17%
Gastrointestinal (sensitivity to smell)
17%
Hiccups
17%
Infection with Normal ANC (Wound), Herpes Z-back-perineal-scrutum
17%
Joint Pain
17%
METABOLIC/LABORATORY (high chloride)
17%
METABOLIC/LABORATORY (low uric acid)
17%
OCULAR SURFACE DISEASE
17%
OCULAR/VISUAL (Right homonymous hemianopsia)
17%
PAIN (BACK)
17%
Pain in extremity
17%
Pruritus
17%
Sinus bradycardia
17%
Voice alteration
17%
Weight loss
17%
Sensory loss left side
17%
Dyspnea
17%
Vomiting
17%
Hypertriglycedidemia
17%
Infection with Normal ANC (Neck NOS), herpes zoster
17%
Insomnia
17%
Neuropathy, Numbness, Right sided
17%
Sore throat
17%
Urinary tract infection
17%
Hyperpigmentation (hands & knuckles)
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase I: Vorinostat + Bevacizumab
Phase II: Bevacizumab
Phase II: Bevacizumab + Vorinostat 400 mg

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Biological: bevacizumabExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
bevacizumab
2002
Completed Phase 3
~3360

Find a Location

Who is running the clinical trial?

Outlook Therapeutics, Inc.Lead Sponsor
4 Previous Clinical Trials
884 Total Patients Enrolled

Media Library

bevacizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05112861 — Phase 3
Age-Related Macular Degeneration Research Study Groups: Biological: bevacizumab
Age-Related Macular Degeneration Clinical Trial 2023: bevacizumab Highlights & Side Effects. Trial Name: NCT05112861 — Phase 3
bevacizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05112861 — Phase 3
~6 spots leftby Mar 2025
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