Age-Related Macular Degeneration Clinical Trial
Official title:
Safety and Effectiveness of ONS-5010 Compared to Lucentis® in Subjects With Neovascular Age-related Macular Degeneration; NORSE EIGHT
Multicenter, randomized, masked, controlled study of the safety and effectiveness of intravitreally administered ONS-5010.
| Status | Recruiting |
| Enrollment | 400 |
| Est. completion date | October 2024 |
| Est. primary completion date | September 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 50 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Clinical Site | Abilene | Texas |
| United States | Clinical Site | Albuquerque | New Mexico |
| United States | Clinical Site | Arcadia | California |
| United States | Clinical Site | Arlington | Texas |
| United States | Clinical Site | Asheville | North Carolina |
| United States | Clinical Site | Austin | Texas |
| United States | Clinical Site | Bakersfield | California |
| United States | Clinical Site | Beaumont | Texas |
| United States | Clinical Site | Bellaire | Texas |
| United States | Clinical Site | Bellevue | Washington |
| United States | Clinical Site | Beverly Hills | California |
| United States | Clinical Site | Charleston | South Carolina |
| United States | Clinical Site | Colorado Springs | Colorado |
| United States | Clinical Site | Coral Springs | Florida |
| United States | Clinical Site | Dallas | Texas |
| United States | Clinical Site | Edina | Minnesota |
| United States | Clinical Site | Edmond | Oklahoma |
| United States | Clinical Site | Fairfax | Virginia |
| United States | Clinical Site | Florence | South Carolina |
| United States | Clinical Site | Fort Lauderdale | Florida |
| United States | Clinical Site | Germantown | Tennessee |
| United States | Clinical Site | Hagerstown | Maryland |
| United States | Clinical Site | Hickory | North Carolina |
| United States | Clinical Site | Huntington Beach | California |
| United States | Clinical Site | Jackson | Mississippi |
| United States | Clinical Site | Jacksonville | Florida |
| United States | Clinical Site | Ladson | South Carolina |
| United States | Clinical Site | Laguna Hills | California |
| United States | Clinical Site | Lakewood | Colorado |
| United States | Clinical Site | Lenexa | Kansas |
| United States | Clinical Site | Lexington | Kentucky |
| United States | Clinical Site | Liverpool | New York |
| United States | Clinical Site | Long Beach | California |
| United States | Clinical Site | Lynchburg | Virginia |
| United States | Clinical Site | Modesto | California |
| United States | Clinical Site | Oak Forest | Illinois |
| United States | Clinical Site | Oak Park | Illinois |
| United States | Clinical Site | Orlando | Florida |
| United States | Clinical Site | Pasadena | California |
| United States | Clinical Site | Poway | California |
| United States | Clinical Site | Rapid City | South Dakota |
| United States | Clinical Site | Rochester | New York |
| United States | Clinical Site | Round Rock | Texas |
| United States | Clinical Site | Sacramento | California |
| United States | Clinical Site | Saint Louis Park | Minnesota |
| United States | Clinical Site | Salt Lake City | Utah |
| United States | Clinical Site | San Antonio | Texas |
| United States | Clinical Site | San Antonio | Texas |
| United States | Clinical Site | Silverdale | Washington |
| United States | Clinical Site | Stuart | Florida |
| United States | Clinical Site | Teaneck | New Jersey |
| United States | Clinical Site | The Woodlands | Texas |
| United States | Clinical Site | Wake Forest | North Carolina |
| United States | Clinical Site | Waterford | Connecticut |
| United States | Clinical Site | West Columbia | South Carolina |
| United States | Clinical Site | Westbury | New York |
| United States | Clinical Site | Willow Park | Texas |
| United States | Clinical Site | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Outlook Therapeutics, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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. | Baseline, 8 weeks |
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