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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®.
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My eye swelling is not due to AMD, DME, or BRVO.
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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.
Select...
I have active inflammation in my eye.
Select...
My study eye has polypoidal choroidal vasculopathy.
Select...
I have had uveitis due to unknown, infectious, or autoimmune causes.
Select...
I do not have any current eye infections.
Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2017 Phase 1 & 2 trial • 96 Patients • NCT01266031100%
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%
Neuropathy, Cranial (Pupil, Upper eyelid)
33%
Aspartate aminotransferase (AST) increased
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have bleeding inside the eye being studied.I have active inflammation in my eye.I have an eye condition that might get worse or need treatment during the study.My eye pressure is high (≥30 mmHg) despite using glaucoma medication.I have previously used Beovu®.I am currently being treated for an infection that affects my whole body.I have never had steroid injections or implants in or around my eye.I have not used anti-VEGF or Avastin® in the last 4 weeks.My eye swelling is not due to AMD, DME, or BRVO.I am a premenopausal woman not using birth control.My study eye has polypoidal choroidal vasculopathy.I have had uveitis due to unknown, infectious, or autoimmune causes.I do not have any current eye infections.I have AMD, DME, or BRVO confirmed by OCT and need anti-VEGF therapy.My eye condition didn't improve after receiving anti-VEGF injections.I have not had laser eye treatment near the center of my vision in the past month.
Research Study Groups:
This trial has the following groups:- Group 1: Biological: bevacizumab
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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