A Randomized, Partially Masked, Controlled, Phase 2b/3 Clinical Study to Evaluate the Efficacy and Safety of RGX-314 Gene Therapy in Participants With nAMD (ATMOSPHERE)

Who is this study for? Patients with Neovascular Age-Related Macular Degeneration
Status: Recruiting
Location: See all (89) locations...
Intervention Type: Genetic, Biological
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

ABBV-RGX-314 (also known as RGX-314) is being developed as a novel one-time gene therapy for the treatment of neovascular (wet) age-related macular degeneration (wet AMD or nAMD). Wet AMD is characterized by loss of vision due to new, leaky blood vessel formation in the retina. Wet AMD is a significant cause of vision loss in the United States, Europe and Japan, with up to 2 million people living with wet AMD in these geographies alone. Current anti-vascular endothelial growth factor (anti-VEGF) therapies have significantly changed the landscape for treatment of wet AMD, becoming the standard of care due to their ability to maintain or prevent progression of vision loss in the majority of patients. These therapies, however, require life-long intraocular injections, typically repeated every 4 to 16 weeks in frequency, to maintain efficacy. Due to the burden of these treatments, patients often experience a decline in vision with reduced frequency of treatment over time.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 89
Healthy Volunteers: f
View:

• Age ≥ 50 years and ≤ 89 years

• An ETDRS BCVA letter score between ≤ 78 and ≥ 40 in the study eye

• Diagnosis of subfoveal CNV secondary to AMD in the study eye previously treated with anti-VEGF

• Must be pseudophakic (at least 12 weeks postcataract surgery) in the study eye.

• Willing and able to provide written, signed informed consent for this study

• Participants must have demonstrated a meaningful response to anti-VEGF therapy at study entry

• An ETDRS BCVA letter score between ≤ 83 and ≥ 40 in both eyes

• Diagnosis of subfoveal choroidal neovascularization (CNV) secondary to AMD in both eyes

• Must be pseudophakic (at least 12 weeks postcataract surgery) in both eyes

• Willing and able to provide written, signed informed consent for this study

• Newcomers must have active disease in the study eye; crossover participants must have active disease in the eye not treated in the main study

Locations
United States
Arkansas
University of Arkansas for Medical Sciences /ID# 271290
RECRUITING
Little Rock
Arizona
Retinal Research Institute /ID# 256019
RECRUITING
Phoenix
Barnet Dulaney Perkins Eye Center - Sun City /ID# 256055
RECRUITING
Sun City
California
Retina Vitreous Assoc Med Grp /ID# 256299
RECRUITING
Beverly Hills
Retinal Diagnostic Center /ID# 256137
RECRUITING
Campbell
The Retina Partners - Encino /ID# 256054
RECRUITING
Encino
Retina Consultants of Orange County /ID# 256152
RECRUITING
Fullerton
Salehi Retina Institute /ID# 263485
RECRUITING
Huntington Beach
UC Irvine/Gavin Herbert Eye Institute /ID# 256145
COMPLETED
Irvine
Northern California Retina Vitreous Associates Medical Group, Inc /ID# 256298
RECRUITING
Mountain View
California Eye Specialists Medical Group Inc. /ID# 256079
RECRUITING
Pasadena
UCLA Doheny Eye Center /ID# 256120
RECRUITING
Pasadena
Retina Consultants of San Diego /ID# 256021
RECRUITING
Poway
Retinal Consultants Medical Group /ID# 256047
RECRUITING
Sacramento
University of California, San Francisco /ID# 256130
RECRUITING
San Francisco
West Coast Retina /ID# 256448
RECRUITING
San Francisco
Orange County Retina Medical Group /ID# 256073
RECRUITING
Santa Ana
California Retina Consultants - Santa Barbara /ID# 256017
COMPLETED
Santa Barbara
Colorado
Retina Consultants of Southern Colorado /ID# 256069
RECRUITING
Colorado Springs
Southwest Retina Research Center /ID# 256136
RECRUITING
Durango
Colorado Retina Associates /ID# 256121
RECRUITING
Lakewood
Connecticut
Retina Group of New England - Waterford /ID# 256071
COMPLETED
Waterford
Florida
Advanced Research, LLC /ID# 275451
RECRUITING
Deerfield Beach
Vitreoretinal Associates, P.A. /ID# 256150
RECRUITING
Gainesville
Florida Retina Consultants /ID# 265661
RECRUITING
Lakeland
Bascom Palmer Eye Institute - University of Miami /ID# 256072
COMPLETED
Miami
Retina Specialty Institute /ID# 256153
RECRUITING
Pensacola
Retina Vitreous Associates of Florida - St. Petersburg /ID# 256050
RECRUITING
St. Petersburg
Southern Vitreoretinal Associates /ID# 256158
RECRUITING
Tallahassee
Georgia
Southeast Retina Center /ID# 256022
RECRUITING
Augusta
Georgia Retina - Marietta /ID# 256142
RECRUITING
Marietta
Marietta Eye Clinic /ID# 268163
RECRUITING
Marietta
Thomas Eye Group PC /ID# 268159
RECRUITING
Sandy Springs
Hawaii
Retina Consultants of Hawaii /ID# 256049
RECRUITING
‘aiea
Illinois
University of Illinois at Chicago /ID# 256300
COMPLETED
Chicago
University Retina and Macula Associates /ID# 256078
RECRUITING
Lemont
University Retina and Macula Associates /ID# 256077
RECRUITING
Oak Forest
Springfield Clinic /ID# 266225
RECRUITING
Springfield
Indiana
Retina Partners Midwest, PC /ID# 256045
RECRUITING
Indianapolis
John-Kenyon American Eye Institute -New Albany /ID# 256065
RECRUITING
New Albany
Kansas
Retina Associates - Lenexa /ID# 256080
RECRUITING
Lenexa
Kentucky
Cincinnati Eye Institute- Edgewood /ID# 256132
RECRUITING
Edgewood
Louisiana
Retina Associates of New Orleans /ID# 272440
RECRUITING
Metairie
Ochsner Medical Center - Jefferson Highway /ID# 270524
RECRUITING
New Orleans
Massachusetts
Ophthalmic Consultants of Boston /ID# 256014
RECRUITING
Boston
Maryland
Johns Hopkins Hospital /ID# 256015
RECRUITING
Baltimore
The Retina Care Center /ID# 256144
RECRUITING
Baltimore
The Retina Group Of Washington - Chevy Chase /ID# 276039
RECRUITING
Chevy Chase
Cumberland Valley Retina Consultants - Hagerstown /ID# 256151
RECRUITING
Hagerstown
Michigan
Retina Associates of Michigan /ID# 266198
RECRUITING
Grand Blanc
Associated Retinal Consultants /ID# 256156
RECRUITING
Royal Oak
Minnesota
VitreoRetinal Surgery PLLC DBA Retina Consultants of Minnesota /ID# 256160
RECRUITING
Edina
Mayo Clinic - Minnesota /ID# 256051
RECRUITING
Rochester
Missouri
The Retina Institute /ID# 266587
RECRUITING
St Louis
North Carolina
Duke Eye Center /ID# 256076
RECRUITING
Durham
Atrium Health Wake Forest Baptist Medical Center /ID# 270767
RECRUITING
Winston-salem
New Mexico
Eye Associates of New Mexico /ID# 256075
RECRUITING
Albuquerque
Nevada
Sierra Eye Associates /ID# 256020
RECRUITING
Reno
New York
Long Island Vitreoretinal Consultants /ID# 256074
COMPLETED
Great Neck
Retina-Vitreous Surgeons of Central New York - Liverpool /ID# 266274
RECRUITING
Liverpool
Ohio
Cleveland Clinic Main Campus /ID# 256064
RECRUITING
Cleveland
Retina Associates of Cleveland-Middleburg Heights /ID# 256052
RECRUITING
Cleveland
Oklahoma
Retina Vitreous Center, Research /ID# 256067
RECRUITING
Edmond
Oregon
Verum Research, LLC /ID# 266585
RECRUITING
Eugene
Retina Northwest, PC /ID# 256140
RECRUITING
Portland
Pennsylvania
Erie Retina Research /ID# 256154
RECRUITING
Erie
Retina Vitreous Consultants - Monroeville /ID# 271654
RECRUITING
Monroeville
Mid Atlantic Retina /ID# 256013
RECRUITING
Philadelphia
South Carolina
Charleston Neuroscience Institute /ID# 256235
RECRUITING
Ladson
South Dakota
Black Hills Regional Eye Institute /ID# 256161
RECRUITING
Rapid City
Tennessee
Charles Retina Institute /ID# 256016
RECRUITING
Germantown
Texas
Retina Research Institute of Texas /ID# 256141
RECRUITING
Abilene
Austin Clinical Research, LLC /ID# 256043
RECRUITING
Austin
Austin Research Center for Retina /ID# 256148
RECRUITING
Austin
Austin Retina Associates - Austin /ID# 256053
RECRUITING
Austin
Retina Consultants of Texas - Beaumont /ID# 266279
RECRUITING
Beaumont
Retina and Vitreous of Texas /ID# 263961
RECRUITING
Bellaire
Texas Retina Associates - Dallas /ID# 256133
RECRUITING
Dallas
Baylor Scott & White Surgicare /ID# 256122
RECRUITING
Fort Worth
Retina Consultants Of Texas /ID# 268611
RECRUITING
San Antonio
Stone Oak Surgery Center /ID# 266199
COMPLETED
San Antonio
Retina Center Of Texas (Rct) - Southlake /ID# 256056
RECRUITING
Southlake
Retina Consultants - The Woodlands /ID# 256018
RECRUITING
The Woodlands
Utah
John A. Moran Eye Center /ID# 256068
RECRUITING
Salt Lake City
Retina Associates of Utah /ID# 256044
RECRUITING
Salt Lake City
Virginia
Wagner Macula & Retina Center - Norfolk /ID# 256134
RECRUITING
Norfolk
Washington
Pacific Northwest Retina /ID# 256155
COMPLETED
Bellevue
Retina Center NW, PLLC /ID# 256157
RECRUITING
Silverdale
Wisconsin
University of Wisconsin-Madison, Department of Ophthalmology and Visual Sciences /ID# 256159
COMPLETED
Madison
Contact Information
Primary
Patient Advocacy
patientadvocacy@regenxbio.com
833-711-0349
Time Frame
Start Date: 2020-12-29
Estimated Completion Date: 2027-11
Participants
Target number of participants: 630
Treatments
Experimental: ABBV-RGX-314 Dose 1
ABBV-RGX-314 Dose 1 administered via subretinal delivery one time.
Experimental: ABBV-RGX-314 Dose 2
ABBV-RGX-314 Dose 2 administered via subretinal delivery one time.
Active_comparator: Control Arm
Ranibizumab administered via intravitreal injection approximately every 28 days
Sponsors
Leads: AbbVie
Collaborators: REGENXBIO Inc.

This content was sourced from clinicaltrials.gov

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