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Anti-VEGF
ONS-5010 for Age-Related Macular Degeneration
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
Active primary Subfoveal Choroidal Neovascularization lesions secondary to Age-related macular degeneration (AMD) in the study eye
Have edema involving the fovea
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 8 weeks
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial is a study that will test the safety and effectiveness of a medication called ONS-5010 when it is given directly into the eye. The study will be conducted at multiple locations and participants
Who is the study for?
This trial is for people with a specific eye condition called neovascular Age-related Macular Degeneration (AMD). Participants must have swelling in the central part of their retina, no scarring or atrophy in that area, active blood vessel growth under the retina due to AMD, and a certain level of vision acuity. They should also show active leakage on an eye test called Fluorescein Angiogram.
What is being tested?
The study is testing ONS-5010's safety and effectiveness compared to other treatments like ranibizumab and bevacizumab. It involves injecting ONS-5010 into the eye to see if it can help with AMD. The trial will randomly assign participants to different treatment groups without them knowing which one they're in.
What are the potential side effects?
While not specified here, common side effects from similar eye injections include redness, discomfort at the injection site, increased intraocular pressure, and possible infection risk. Individual experiences may vary.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have wet AMD with active lesions in the center of my vision.
Select...
I have swelling in the central part of my retina.
Select...
My eyes do not have scarring or damage in the central vision area.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 8 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Evaluate the effectiveness of intravitreal injections of ONS-5010 compared to ranibizumab in preventing vision loss, as measured by the mean change in baseline best correct visual acuity (BCVA) at Week 8
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%
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
2Treatment groups
Experimental Treatment
Active Control
Group I: ONS-5010 bevacizumabExperimental Treatment1 Intervention
Group II: ranibizumabActive Control1 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
604 Total Patients Enrolled