Clinical trial NCT03834753: A Clinical Effectiveness Study Examining the Efficacy and Safety of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Age-related Macular Degeneration
Neovascular Age-related Macular Degeneration
Wet Macular Degeneration
Keywords: Subfoveal Choroidal Neovascularization
Lead sponsor: Outlook Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2019-02-08
Enrollment: 228
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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 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

Primary outcomes:
measure: Proportion of subjects who gain 15 or more letters in best corrected visual acuity (BCVA)
timeFrame: Baseline, 11 months
Secondary outcomes:
measure: Mean change in the best corrected visual acuity
timeFrame: Baseline, monthly to 11 months
measure: Proportion of participants who gain at least 10 letters in the best corrected visual acuity
timeFrame: Baseline, 11 months
measure: Proportion of participants who gain at least 5 letters in the best corrected visual acuity
timeFrame: Baseline, 11 months
measure: Proportion of participants who lose fewer than 15 letters in the best corrected visual acuity
timeFrame: Baseline, 11 months
measure: Proportion of participants with visual-acuity Snellen equivalent of 20/200 or worse
timeFrame: Baseline, 11 months
measure: Percentage of participants with ocular adverse events, non-ocular adverse events, grade 3 and above laboratory abnormalities, and vital sign abnormalities
timeFrame: 11 months, 12 months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Clinical Site
state: Arizona
city: Arcadia
country: United States
facility: Clinical Site
state: California
city: Beverly Hills
country: United States
facility: Clinical Site
state: California
city: Campbell
country: United States
facility: Clinical Site
state: California
city: Glendale
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: Mountain View
country: United States
facility: Clinical Site
state: California
city: Oxnard
country: United States
facility: Clinical Site
state: California
city: Palm Desert
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: Santa Maria
country: United States
facility: Clinical Site
state: California
city: Tustin
country: United States
facility: Clinical Site
state: California
city: Golden
country: United States
facility: Clinical Site
state: Colorado
city: Hamden
country: United States
facility: Clinical Site
state: Connecticut
city: Clearwater
country: United States
facility: Clinical Site
state: Florida
city: Pinellas Park
country: United States
facility: Clinical Site
state: Florida
city: Sarasota
country: United States
facility: Clinical Site
state: Florida
city: Winter Haven
country: United States
facility: Clinical Site
state: Florida
city: Augusta
country: United States
facility: Clinical Site
state: Georgia
city: Marietta
country: United States
facility: Clinical Site
state: Georgia
city: Downers Grove
country: United States
facility: Clinical Site
state: Illinois
city: Lemont
country: United States
facility: Clinical Site
state: Illinois
city: Springfield
country: United States
facility: Clinical Site
state: Illinois
city: Indianapolis
country: United States
facility: Clinical Site
state: Indiana
city: Hagerstown
country: United States
facility: Clinical Site
state: Maryland
city: Edina
country: United States
facility: Clinical Site
state: Minnesota
city: Saint Louis
country: United States
facility: Clinical Site
state: Missouri
city: Bloomfield
country: United States
facility: Clinical Site
state: New Jersey
city: Albuquerque
country: United States
facility: Clinical Site
state: New Mexico
city: New York
country: United States
facility: Clinical Site
state: New York
city: Chambersburg
country: United States
facility: Clinical Site
state: Pennsylvania
city: Monroeville
country: United States
facility: Clinical Site
state: Pennsylvania
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: Amarillo
country: United States
facility: Clinical Site
state: Texas
city: Arlington
country: United States
facility: Clinical Site
state: Texas
city: Dallas
country: United States
facility: Clinical Site
state: Texas
city: Grapevine
country: United States
facility: Clinical Site
state: Texas
city: Houston
country: United States
facility: Clinical Site
state: Texas
city: McAllen
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 City
country: United States
facility: Clinical Site
state: Utah
city: Norfolk
country: United States
facility: Clinical Site
state: Virginia
city: Madison
country: United States
facility: Clinical Site
state: Wisconsin
Study officials:
affiliation: Outlook Therapeutics, Inc.
name: Jennifer M Kissner, PhD
role: STUDY_DIRECTOR
References: