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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

NORSE SEVEN 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.Check my eligibility
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.See study design
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.

NORSE SEVEN Trial Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Frequency and incidence of treatment-emergent adverse events following intravitreal injections of ONS-5010 in vials or PFS

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%
Neuropathy, Sensory Legs/Toes tingling
33%
Neuropathy, Cranial (Pupil, Upper eyelid)
33%
Aspartate aminotransferase (AST) increased
33%
Taste Alteration
33%
Stomach pain
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

NORSE SEVEN 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How is bevacizumab being employed by doctors today?

"bevacizumab is most often used to fight cancer. However, it can also be used to treat recurrent platinum sensitive primary peritoneal cancer, stage iv epithelial ovarian cancer following initial surgical resection, and locally advanced nonsquamous non-small cell lung cancer."

Answered by AI

What is the maximum capacity for this experiment?

"This study has already collected the number of participants it needs and is no longer recruiting. The trial was first posted on November 15th 2021 and was last updated on December 6th 2021. With that said, there are presently 373 studies actively looking for patients with wet macular degeneration and 379 studies for bevacizumab actively enrolling participants."

Answered by AI

What is the precedent for bevacizumab's success in clinical trials?

"In 2004, bevacizumab was first studied at Memoral Sloan Kettering Basking Ridge. As of now, 1004 completed studies have been conducted on this medication. At the moment, 379 clinical trials are still active. A large number of these trials are taking place in Hagerstown, Maryland."

Answered by AI

Are there any positions available for patients in this trial?

"Presently, this study is not looking for new patients to enroll. The trial was initially posted on November 15th, 2021 and was most recently updated on December 6th, 2021. There are currently 373 and 379 other clinical trials respectively recruiting patients with wet macular degeneration and bevacizumab."

Answered by AI

Who else is applying?

What site did they apply to?
Clinical Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A 3-month Study to Compare the Safety of ONS-5010 in Vials Versus Pre-filled Syringe in Subjects With Visual Impairment Due to Retinal Disorders
2021. "A 3-month Study to Compare the Safety of ONS-5010 in Vials Versus Pre-filled Syringe in Subjects With Visual Impairment Due to Retinal Disorders". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05112861.
All > Macular Edema > Wet Macular Degeneration
~31 spots leftby Mar 2025
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