Clinical trial NCT06190093: A 3-month Study to Assess the Safety and Effectiveness of ONS-5010 in Subjects with Neovascular Age-related Macular Degeneration (AMD)
Official title: Safety and Effectiveness of ONS-5010 Compared to Lucentis® in Subjects with Neovascular Age-related Macular Degeneration; NORSE EIGHT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neovascular Age-related Macular Degeneration
Age-Related Macular Degeneration
Wet Macular Degeneration
Lead sponsor: Outlook Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2024-01-05
Enrollment: 400
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Multicenter, randomized, masked, controlled study of the safety and effectiveness of intravitreally administered ONS-5010.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Baseline, 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Arcadia
country: United States
facility: Clinical Site
state: California
city: Bakersfield
country: United States
facility: Clinical Site
state: California
city: Beverly Hills
country: United States
facility: Clinical Site
state: California
city: Huntington Beach
country: United States
facility: Clinical Site
state: California
city: Laguna Hills
country: United States
facility: Clinical Site
state: California
city: Long Beach
country: United States
facility: Clinical Site
state: California
city: Modesto
country: United States
facility: Clinical Site
state: California
city: Oakland
country: United States
facility: Clinical Site
state: California
city: Pasadena
country: United States
facility: Clinical Site
state: California
city: Poway
country: United States
facility: Clinical Site
state: California
city: Sacramento
country: United States
facility: Clinical Site
state: California
city: Colorado Springs
country: United States
facility: Clinical Site
state: Colorado
city: Lakewood
country: United States
facility: Clinical Site
state: Colorado
city: Waterford
country: United States
facility: Clinical Site
state: Connecticut
city: Coral Springs
country: United States
facility: Clinical Site
state: Florida
city: Fort Lauderdale
country: United States
facility: Clinical Site
state: Florida
city: Jacksonville
country: United States
facility: Clinical Site
state: Florida
city: Orlando
country: United States
facility: Clinical Site
state: Florida
city: Stuart
country: United States
facility: Clinical Site
state: Florida
city: Oak Forest
country: United States
facility: Clinical Site
state: Illinois
city: Oak Park
country: United States
facility: Clinical Site
state: Illinois
city: Carmel
country: United States
facility: Clinical Site
state: Indiana
city: Lenexa
country: United States
facility: Clinical Site
state: Kansas
city: Lexington
country: United States
facility: Clinical Site
state: Kentucky
city: Hagerstown
country: United States
facility: Clinical Site
state: Maryland
city: Edina
country: United States
facility: Clinical Site
state: Minnesota
city: Saint Louis Park
country: United States
facility: Clinical Site
state: Minnesota
city: Jackson
country: United States
facility: Clinical Site
state: Mississippi
city: Teaneck
country: United States
facility: Clinical Site
state: New Jersey
city: Albuquerque
country: United States
facility: Clinical Site
state: New Mexico
city: Liverpool
country: United States
facility: Clinical Site
state: New York
city: Oceanside
country: United States
facility: Clinical Site
state: New York
city: Rochester
country: United States
facility: Clinical Site
state: New York
city: Westbury
country: United States
facility: Clinical Site
state: New York
city: Asheville
country: United States
facility: Clinical Site
state: North Carolina
city: Hickory
country: United States
facility: Clinical Site
state: North Carolina
city: Wake Forest
country: United States
facility: Clinical Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Clinical Site
state: North Carolina
city: Edmond
country: United States
facility: Clinical Site
state: Oklahoma
city: Charleston
country: United States
facility: Clinical Site
state: South Carolina
city: Florence
country: United States
facility: Clinical Site
state: South Carolina
city: Ladson
country: United States
facility: Clinical Site
state: South Carolina
city: West Columbia
country: United States
facility: Clinical Site
state: South Carolina
city: Rapid City
country: United States
facility: Clinical Site
state: South Dakota
city: Germantown
country: United States
facility: Clinical Site
state: Tennessee
city: Abilene
country: United States
facility: Clinical Site
state: Texas
city: Arlington
country: United States
facility: Clinical Site
state: Texas
city: Austin
country: United States
facility: Clinical Site
state: Texas
city: Beaumont
country: United States
facility: Clinical Site
state: Texas
city: Bellaire
country: United States
facility: Clinical Site
state: Texas
city: Dallas
country: United States
facility: Clinical Site
state: Texas
city: Round Rock
country: United States
facility: Clinical Site
state: Texas
city: San Antonio
country: United States
facility: Clinical Site
state: Texas
city: San Antonio
country: United States
facility: Clinical Site
state: Texas
city: The Woodlands
country: United States
facility: Clinical Site
state: Texas
city: Willow Park
country: United States
facility: Clinical Site
state: Texas
city: Salt Lake
country: United States
facility: Clinical Site
state: Utah
city: Fairfax
country: United States
facility: Clinical Site
state: Virginia
city: Lynchburg
country: United States
facility: Clinical Site
state: Virginia
city: Bellevue
country: United States
facility: Clinical Site
state: Washington
city: Silverdale
country: United States
facility: Clinical Site
state: Washington
Study officials:
References: