A 3-month Study to Assess the Safety and Effectiveness of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD)
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ClinicalTrials.gov Identifier: NCT06190093 |
Recruitment Status :
Recruiting
First Posted : January 5, 2024
Last Update Posted : May 10, 2024
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Neovascular Age-related Macular Degeneration Age-Related Macular Degeneration Wet Macular Degeneration | Biological: bevacizumab Biological: ranibizumab | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 400 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Safety and Effectiveness of ONS-5010 Compared to Lucentis® in Subjects With Neovascular Age-related Macular Degeneration; NORSE EIGHT |
Actual Study Start Date : | January 24, 2024 |
Estimated Primary Completion Date : | September 2024 |
Estimated Study Completion Date : | October 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: ONS-5010 bevacizumab |
Biological: bevacizumab
1.25 mg, intravitreal injection
Other Name: ONS-5010 |
Active Comparator: ranibizumab |
Biological: ranibizumab
0.5mg, intravitreal injection |
- 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 [ Time Frame: Baseline, 8 weeks ]BCVA to be assessed as letters read using the Early Treatment Diabetic Retinopathy Study (ETDRS) charts. A positive change represents an improvement in visual acuity.
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Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Active primary Subfoveal Choroidal Neovascularization lesions secondary to Age-related macular degeneration (AMD) in the study eye
- Best corrected visual acuity of 35-75 letters read (20/32 to 20/200 Snellen equivalent)
- Study eye must:
- Have active leakage on Fluorescein Angiogram involving the fovea
- Have edema involving the fovea
- Be free of scarring, fibrosis, or atrophy involving the central foveal zone
Exclusion Criteria:
- Previous subfoveal focal laser photocoagulation 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 within 1 year
- Active intraocular inflammation (grade trace or above) in the study eye
- Current vitreous hemorrhage in the study eye
- Polypoidal choroidal vasculopathy (PCV) in the study eye
- History of idiopathic or autoimmune-associated uveitis in either eye
- Infectious 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 or history of allergy to fluorescein , not amenable to treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06190093
Contact: SVP, Clinical & Regulatory Affairs | 6154232150 | Jenniferkissner@outlooktherapeutics.com |
Responsible Party: | Outlook Therapeutics, Inc. |
ClinicalTrials.gov Identifier: | NCT06190093 |
Other Study ID Numbers: |
ONS-5010-008 |
First Posted: | January 5, 2024 Key Record Dates |
Last Update Posted: | May 10, 2024 |
Last Verified: | May 2024 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Macular Degeneration Wet Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases Bevacizumab Ranibizumab |
Antineoplastic Agents, Immunological Antineoplastic Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |