Age-related Macular Degeneration Clinical Trial
Official title:
A Clinical Effectiveness, Multicenter, Randomized, Double-masked, Controlled Study of the Efficacy and Safety of ONS-5010 in Subjects With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration
| Verified date | February 2022 |
| Source | Outlook Therapeutics, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This research study will examine the safety and effectiveness of ONS-5010 in participants with AMD. The goal is to prevent vision loss by evaluating the effectiveness of ONS-5010 as compared with ranibizumab.
| Status | Completed |
| Enrollment | 228 |
| Est. completion date | July 8, 2021 |
| Est. primary completion date | June 7, 2021 |
| 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 25-67 letters read (20/50 to 20/320 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 haemorrhage 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 | Amarillo | Texas |
| United States | Clinical Site | Arcadia | California |
| United States | Clinical Site | Arlington | Texas |
| United States | Clinical Site | Augusta | Georgia |
| United States | Clinical Site | Beverly Hills | California |
| United States | Clinical Site | Bloomfield | New Jersey |
| United States | Clinical Site | Campbell | California |
| United States | Clinical Site | Chambersburg | Pennsylvania |
| United States | Clinical Site | Clearwater | Florida |
| United States | Clinical Site | Dallas | Texas |
| United States | Clinical Site | Downers Grove | Illinois |
| United States | Clinical Site | Edina | Minnesota |
| United States | Clinical Site | Germantown | Tennessee |
| United States | Clinical Site | Glendale | California |
| United States | Clinical Site | Golden | Colorado |
| United States | Clinical Site | Grapevine | Texas |
| United States | Clinical Site | Hagerstown | Maryland |
| United States | Clinical Site | Hamden | Connecticut |
| United States | Clinical Site | Houston | Texas |
| United States | Clinical Site | Indianapolis | Indiana |
| United States | Clinical Site | Laguna Hills | California |
| United States | Clinical Site | Lemont | Illinois |
| United States | Clinical Site | Long Beach | California |
| United States | Clinical Site | Madison | Wisconsin |
| United States | Clinical Site | Marietta | Georgia |
| United States | Clinical Site | McAllen | Texas |
| United States | Clinical Site | Monroeville | Pennsylvania |
| United States | Clinical Site | Mountain View | California |
| United States | Clinical Site | New York | New York |
| United States | Clinical Site | Norfolk | Virginia |
| United States | Clinical Site | Oxnard | California |
| United States | Clinical Site | Palm Desert | California |
| United States | Clinical Site | Pinellas Park | Florida |
| United States | Clinical Site | Poway | California |
| United States | Clinical Site | Rapid City | South Dakota |
| United States | Clinical Site | Sacramento | California |
| United States | Clinical Site | Saint Louis | Missouri |
| 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 | Santa Maria | California |
| United States | Clinical Site | Sarasota | Florida |
| United States | Clinical Site | Springfield | Illinois |
| United States | Clinical Site | The Woodlands | Texas |
| United States | Clinical Site | Tucson | Arizona |
| United States | Clinical Site | Tustin | California |
| United States | Clinical Site | Willow Park | Texas |
| United States | Clinical Site | Winter Haven | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Outlook Therapeutics, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Proportion of subjects who gain 15 or more letters in best corrected visual acuity (BCVA) | 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, 11 months | |
| Secondary | Mean change in the best corrected visual acuity | BCVA to be assessed as letters read using the ETDRS charts. A positive change represents an improvement in visual acuity. | Baseline, monthly to 11 months | |
| Secondary | Proportion of participants who gain at least 10 letters in the best corrected visual acuity | BCVA to be assessed as letters read using the ETDRS charts. A positive change represents an improvement in visual acuity. | Baseline, 11 months | |
| Secondary | Proportion of participants who gain at least 5 letters in the best corrected visual acuity | BCVA to be assessed as letters read using the ETDRS charts. A positive change represents an improvement in visual acuity. | Baseline, 11 months | |
| Secondary | Proportion of participants who lose fewer than 15 letters in the best corrected visual acuity | BCVA to be assessed as letters read using the ETDRS charts. A negative change represents a decrease in visual acuity. | Baseline, 11 months | |
| Secondary | Proportion of participants with visual-acuity Snellen equivalent of 20/200 or worse | Baseline, 11 months | ||
| Secondary | Percentage of participants with ocular adverse events, non-ocular adverse events, grade 3 and above laboratory abnormalities, and vital sign abnormalities | 11 months, 12 months |
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