Clinical trial NCT04465955: A Study of NGM621 in Participants With Geographic Atrophy
Official title: A Phase 2 Multicenter, Randomized, Double-Masked, Sham-Controlled Study of the Safety and Efficacy of Intravitreal Injections of NGM621 in Subjects With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Geographic Atrophy
Lead sponsor: NGM Biopharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2020-07-10
Enrollment: 320
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multi-center evaluation of NGM621 in a randomized, double-masked, sham-controlled study in participants with Geographic Atrophy secondary to Age-related Macular Degeneration.


Eligibility criteria: Inclusion Criteria:

* Male or female (non-pregnant, non-lactating) subjects ≥ 55 years
* Standard luminance BCVA score of 34 letters or better using ETDRS charts at the starting distance of 4 meters (approximately 20/200 Snellen equivalent or better) in study eye
* Clinical diagnosis of GA secondary to AMD:

  1. Total GA area must be ≥ 2.5 and ≤ 17.5 mm²
  2. If GA is multifocal, at least one focal lesion must be ≥ 1.25 mm² (0.5 DA), with the overall area of GA ≥ 2.5 and ≤ 17.5 mm²
  3. Well demarcated GA with no anatomical evidence of current or prior CNV in the study eye

Exclusion Criteria:

Study Eye

* GA secondary to a condition other than AMD in either eye (e.g., monogenetic macular dystrophies like Stargardt disease, cone rod dystrophy, or toxic maculopathies)
* Any history of or active choroidal neovascularization (CNV)

Both Eyes

* Any history of or active bacterial, viral, fungal, or parasitic infection in either eye in the 3 months prior to randomization

Primary outcomes:
measure: The rate of change in GA lesion area as measured by fundus autofluorescence (FAF) over the 52 weeks of treatment
timeFrame: 52 Weeks
measure: The incidence and severity of ocular and systemic adverse events from treatment with NGM621 administered every 4 or 8 weeks compared to Sham
timeFrame: 52 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Associated Retina Consultants
state: Arizona
city: Bakersfield
country: United States
facility: California Retina Consultants
state: California
city: Beverly Hills
country: United States
facility: Retina Vitreous Associates
state: California
city: Campbell
country: United States
facility: Retinal Diagnostic Center
state: California
city: Encino
country: United States
facility: The Retina Partners
state: California
city: Fullerton
country: United States
facility: Retina Consultants of Orange County
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Health
state: California
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
city: Mountain View
country: United States
facility: Northern California Retina Vitreous Associates
state: California
city: Palm Desert
country: United States
facility: Retina Institute of California
state: California
city: Pasadena
country: United States
facility: California Eye Specialists
state: California
city: Poway
country: United States
facility: Retina Consultants San Diego
state: California
city: Sacramento
country: United States
facility: Retinal Consultants Medical Group Inc
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Santa Ana
country: United States
facility: Orange County Retina Medical Group
state: California
city: Santa Barbara
country: United States
facility: California Retina Consultants
state: California
city: Colorado Springs
country: United States
facility: Retina Consultants of Southern Colorado PC
state: Colorado
city: Golden
country: United States
facility: Colorado Retina Associates PC
state: Colorado
city: Waterford
country: United States
facility: New England Retina Associates PC
state: Connecticut
city: Boynton Beach
country: United States
facility: Florida Eye Microsurgical Institute
state: Florida
city: Coral Gables
country: United States
facility: University of Miami
state: Florida
city: Coral Springs
country: United States
facility: Specialty Retina Center (Coral Springs)
state: Florida
city: Fort Lauderdale
country: United States
facility: Retina Group of Florida
state: Florida
city: Fort Myers
country: United States
facility: National Ophthalmic Research Institute
state: Florida
city: Melbourne
country: United States
facility: Florida Eye Associates
state: Florida
city: Pensacola
country: United States
facility: Retina Specialty Institute
state: Florida
city: Tallahassee
country: United States
facility: Southern Vitreoretinal Associates
state: Florida
city: Tampa
country: United States
facility: Retina Vitreous Associates of Florida
state: Florida
city: Marietta
country: United States
facility: Georgia Retina PC
state: Georgia
city: Bloomington
country: United States
facility: Gailey Eye Clinic - Bloomington
state: Illinois
city: Chicago
country: United States
facility: University of Illinois
state: Illinois
city: Lemont
country: United States
facility: University Retina and Macula Associates, PC
state: Illinois
city: Indianapolis
country: United States
facility: Raj K. Maturi, MD, PC
state: Indiana
city: Shawnee Mission
country: United States
facility: Retina Associates, PA
state: Kansas
city: Baltimore
country: United States
facility: Thompson Sjaarda, PA
state: Maryland
city: Baltimore
country: United States
facility: Elman Retina Group PA
state: Maryland
city: Boston
country: United States
facility: Ophthalmic Consultants of Boston
state: Massachusetts
city: Royal Oak
country: United States
facility: Associated Retina Consultants PC
state: Michigan
city: Traverse City
country: United States
facility: Associated Retina Consultants PC
state: Michigan
city: Minneapolis
country: United States
facility: Vitreoretinal Surgery PA
state: Minnesota
city: Southaven
country: United States
facility: Deep Blue Retina Clinical Research
state: Mississippi
city: Reno
country: United States
facility: Sierra Eye Associates
state: Nevada
city: Great Neck
country: United States
facility: Long Island Vitreoretinal Consultants
state: New York
city: New York
country: United States
facility: Vitreous Retina Macula Consultants of NY
state: New York
city: Troy
country: United States
facility: Albany Troy Cataract & Laser Associates
state: New York
city: Asheville
country: United States
facility: Western Carolina Retinal Associates
state: North Carolina
city: Charlotte
country: United States
facility: Southeast Clinical Research
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Cincinnati
country: United States
facility: Sterling Research Group, Ltd.
state: Ohio
city: Cleveland
country: United States
facility: Retina Associates of Cleveland
state: Ohio
city: Cleveland
country: United States
facility: The Cleveland Clinic
state: Ohio
city: Springfield
country: United States
facility: Cascade Medical Research Institute
state: Oregon
city: Kingston
country: United States
facility: Eye Care Specialists
state: Pennsylvania
city: Philadelphia
country: United States
facility: Retinovitreous Associates
state: Pennsylvania
city: Rapid City
country: United States
facility: Black Hills Regional Eye Institute
state: South Dakota
city: Knoxville
country: United States
facility: Southeastern Retina Associates
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Retina
state: Tennessee
city: Arlington
country: United States
facility: Texas Retina Associates
state: Texas
city: Dallas
country: United States
facility: Retina Foundation of the Southwest
state: Texas
city: Dallas
country: United States
facility: Texas Retina Associates-Plano
state: Texas
city: Houston
country: United States
facility: Retina Consultants of Houston
state: Texas
city: The Woodlands
country: United States
facility: Retina Consultants of Houston
state: Texas
city: Willow Park
country: United States
facility: Strategic Clinical Research Group, LLC
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Spokane
country: United States
facility: Spokane Eye Clinical Research
state: Washington
Study officials:
affiliation: NGM Biopharmaceuticals
name: NGM Study Director
role: STUDY_DIRECTOR
References: