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Pivotal 1 Study of RGX-314 Gene Therapy in Participants With nAMD (ATMOSPHERE)

Primary Purpose

AMD, nAMD, Wet Age-related Macular Degeneration

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
RGX-314
RGX-314
Ranibizumab (LUCENTIS®)
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for AMD focused on measuring Age-Related Macular Degeneration, Neovascular Age-Related Macular Degeneration, Macular Degeneration, Wet Macular Degeneration, Choroidal Neovascularization, Retinal Degeneration, Retinal Diseases, Eye Diseases, Ranibizumab, Angiogenesis Inhibitors, Angiogenesis Modulating Agents, Growth Substances, Physiological Effects of Drugs, Growth Inhibitors, Antineoplastic Agents, Gene therapy, Anti-vascular endothelial grown factory therapy, Anti-VEGF therapy

Eligibility Criteria

50 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age ≥ 50 years and ≤ 89 years
  2. An ETDRS BCVA letter score between ≤ 78 and ≥ 40 in the study eye
  3. Diagnosis of subfoveal CNV secondary to AMD in the study eye previously treated with anti-VEGF
  4. Must be pseudophakic (at least 12 weeks postcataract surgery) in the study eye.
  5. Willing and able to provide written, signed informed consent for this study
  6. Participants must have demonstrated a meaningful response to anti-VEGF therapy at study entry

Exclusion Criteria:

  1. CNV or macular edema in the study eye secondary to any causes other than AMD
  2. Subfoveal fibrosis or atrophy in the study eye
  3. Any condition in the investigator's opinion that could limit VA improvement in the study eye
  4. Active or history of retinal detachment in the study eye
  5. Uncontrolled glaucoma in the study eye
  6. History of intraocular surgery in the study eye within 12 weeks prior to Screening Visit 1
  7. History of intravitreal therapy in the study eye, such as intravitreal steroid injection or investigational product, other than anti-VEGF therapy, in the 6 months prior to Screening Visit 1.
  8. Prior treatment with gene therapy.
  9. Recent myocardial infarction, cerebrovascular accident, or transient ischemic attack within the past 6 months.

Sites / Locations

  • Retinal Consultants of Arizona, Ltd.Recruiting
  • Barnet Dulaney Perkins Eye Center - PhoenixRecruiting
  • Retina-Vitreous Associates Medical GroupRecruiting
  • Retinal Diagnostic CenterRecruiting
  • The Retina Partners - EncinoRecruiting
  • Retina Consultants of Orange County - Fullerton OfficeRecruiting
  • University of California Irvine - School of Medicine - The Gavin Herbert Eye InstituteRecruiting
  • Doheny Eye Institute - Doheny Eye Center - ArcadiaRecruiting
  • Northern California Retina Vitreous Associates Medical Group, Inc. - Mountain View OfficeRecruiting
  • California Eye Specialists Medical Group Inc. - PasadenaRecruiting
  • Retina Consultants San DiegoRecruiting
  • Retina ConsultantsRecruiting
  • West Coast Retina Medical Group - San Francisco OfficeRecruiting
  • UCSF Medical Center - Retina and Vitreous ClinicRecruiting
  • Orange County Retina Medical GroupRecruiting
  • California Retina ConsultantsRecruiting
  • Retina Consultants of Southern Colorado PC- Colorado SpringsRecruiting
  • Southwest Retina ConsultantsRecruiting
  • Colorado Retina Associates (CRA) - Red Rocks Medical Center LocationRecruiting
  • Retina Group of New England - New LondonRecruiting
  • Vitreo Retinal Associates PA - The Millennium CenterRecruiting
  • Florida Retina Consultants - Lakeland
  • Bascom Palmer Eye Institute - University of Miami Health SystemRecruiting
  • Retina Specialty Institute - PensacolaRecruiting
  • Retina Vitreous Associates of Florida (RVA) - Saint PetersburgRecruiting
  • Southern Vitreoretinal Associates, P.L.
  • Southeast Retina Center
  • Georgia Retina PC - MariettaRecruiting
  • Retina Consultants of Hawaii (RCH) - Pali Momi Medical Center LocationRecruiting
  • Illinois Eye and Ear Infirmary at UI Health UICRecruiting
  • University Retina and Macula Associates, P.C. - Lemont OfficeRecruiting
  • University Retina and Macula Associates, PC - Oak ForestRecruiting
  • Springfield Clinic
  • Springfield Clinic
  • Midwest Eye InstituteRecruiting
  • John-Kenyon American Eye Institute - New AlbanyRecruiting
  • Retina Associates, P.A. - Shawnee MissionRecruiting
  • The Retina Care Center, LLCRecruiting
  • The Johns Hopkins Hospital - Wilmer Eye Institute - East BaltimoreRecruiting
  • Cumberland Valley Retina Consultants (CVRC)Recruiting
  • Ophthalmic Consultants of Boston, Inc.Recruiting
  • Retina Associates of Michigan - Grand Blanc Office
  • Associated Retinal Consultants P.C.Recruiting
  • VitreoRetinal Surgery, PA - Edina LocationRecruiting
  • Mayo Clinic - MinnesotaRecruiting
  • Sierra Eye AssociatesRecruiting
  • Eye Associates of New Mexico - Albuquerque - Retina Center LocationRecruiting
  • Long Island Vitreoretinal Consultants - Great NeckRecruiting
  • Duke Eye Center - Erwin Road - Duke University Medical CenterRecruiting
  • Wake Forest Baptist Medical Center
  • Cincinnati Eye Institute - Blue AshRecruiting
  • Retina Associates of Cleveland, Inc. - Middleburg Heights OfficeRecruiting
  • Cleveland ClinicRecruiting
  • Retina Vitreous Center (RVC)Recruiting
  • Retina Northwest, PCRecruiting
  • Erie Retinal Surgery, IncRecruiting
  • Mid Atlantic Retina - PhiladelphiaRecruiting
  • Charleston Neuroscience InstituteRecruiting
  • Black Hills Regional Eye InstituteRecruiting
  • Charles Retina InstituteRecruiting
  • West Texas Retina Consultants (WTRC) - Abilene LocationRecruiting
  • Austin Retina AssociatesRecruiting
  • Retina Consultants of AustinRecruiting
  • Austin Clinical Research, LLCRecruiting
  • Star RetinaRecruiting
  • Texas Retina AssociatesRecruiting
  • Star Vision Consultants
  • Retina Associates of South Texas, PA - San Antonio
  • Retinal Consultants of San Antonio (RCSA) - Medical Center
  • Retina Center of Texas - SouthlakeRecruiting
  • Retina Consultants of Texas - The WoodlandsRecruiting
  • Retina Associates of Utah, PCRecruiting
  • John A. Moran Eye Center - University of Utah Health CareRecruiting
  • Wagner Macula & Retina CenterRecruiting
  • Pacific Northwest RetinaRecruiting
  • Retina Center Northwest - SilverdaleRecruiting
  • University of Wisconsin Health - University Station ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

RGX-314 Dose 1

RGX-314 Dose 2

Control Arm

Arm Description

RGX-314 Dose 1 administered via subretinal delivery one time.

RGX-314 Dose 2 administered via subretinal delivery one time.

Ranibizumab administered via intravitreal injection approximately every 28 days

Outcomes

Primary Outcome Measures

Mean change from baseline in Best Corrected Visual Acuity (BCVA)
BCVA measured by Early Treatment Diabetic Retinopathy Study (ETDRS)

Secondary Outcome Measures

Incidences of ocular and overall adverse events (AEs)
Evaluate the safety and tolerability of RGX-314
Mean change from baseline in BCVA
BCVA measured by ETDRS
Mean change from baseline in Central Retinal Thickness (CRT) and Center Point Thickness (CPT) as measured by Spectral Domain Optical Coherence Tomography (SD-OCT)
Mean reduction in supplemental anti VEGF injection annualized rate compared with the prior 52 weeks preceding the first ranibizumab injection received as part of the Active Run-in Period (RGX 314 randomized participants)
Mean supplemental anti-VEGF injection annualized rate in the RGX-314 arms
Aqueous RGX-314 target protein (TP) concentrations

Full Information

First Posted
January 8, 2021
Last Updated
May 18, 2023
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT04704921
Brief Title
Pivotal 1 Study of RGX-314 Gene Therapy in Participants With nAMD
Acronym
ATMOSPHERE
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 29, 2020 (Actual)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
May 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RGX-314 is being developed as a novel one-time gene therapy for the treatment of neovascular (wet) age-related macular degeneration (wet AMD). 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-VEGF therapies have significantly changed the landscape for treatment of wet AMD, becoming the standard of care due to their ability to prevent progression of vision loss in the majority of patients. These therapies, however, require life-long intraocular injections, typically repeated every four to 12 weeks in frequency, to maintain efficacy. Due to the burden of treatment, patients often experience a decline in vision with reduced frequency of treatment over time. RGX-314 is being developed as a potential one-time treatment for wet AMD.
Detailed Description
This randomized, partially masked, controlled, Phase 2b/3 clinical study will evaluate the efficacy and safety of RGX-314 gene therapy in participants with nAMD. The study will evaluate 2 dose levels of RGX-314 relative to an active comparator. The primary endpoint of this study is mean change in best-corrected visual acuity (BCVA) of RGX-314 relative to ranibizumab. Approximately 300 participants who meet the inclusion/exclusion criteria, will be enrolled into one of 3 arms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
AMD, nAMD, Wet Age-related Macular Degeneration, wAMD, Wet AMD, CNV
Keywords
Age-Related Macular Degeneration, Neovascular Age-Related Macular Degeneration, Macular Degeneration, Wet Macular Degeneration, Choroidal Neovascularization, Retinal Degeneration, Retinal Diseases, Eye Diseases, Ranibizumab, Angiogenesis Inhibitors, Angiogenesis Modulating Agents, Growth Substances, Physiological Effects of Drugs, Growth Inhibitors, Antineoplastic Agents, Gene therapy, Anti-vascular endothelial grown factory therapy, Anti-VEGF therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
2 RGX-314 treatment arms, 1 control arm (ranibizumab)
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The administration of RGX-314 requires an outpatient surgical procedure performed in an operating room, while the active control, ranibizumab, is administered via intravitreal injection in an office setting. This study will be partially masked which will include masking of key study assessors and study drug dose.
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RGX-314 Dose 1
Arm Type
Experimental
Arm Description
RGX-314 Dose 1 administered via subretinal delivery one time.
Arm Title
RGX-314 Dose 2
Arm Type
Experimental
Arm Description
RGX-314 Dose 2 administered via subretinal delivery one time.
Arm Title
Control Arm
Arm Type
Active Comparator
Arm Description
Ranibizumab administered via intravitreal injection approximately every 28 days
Intervention Type
Genetic
Intervention Name(s)
RGX-314
Intervention Description
AAV8 vector containing a transgene for anti-VEGF Fab (Dose 1)
Intervention Type
Genetic
Intervention Name(s)
RGX-314
Intervention Description
AAV8 vector containing a transgene for anti-VEGF Fab (Dose 2)
Intervention Type
Biological
Intervention Name(s)
Ranibizumab (LUCENTIS®)
Other Intervention Name(s)
Ranibizumab (anti-VEGF agent)
Intervention Description
0.5 mg (0.05 mL of 10 mg/mL solution) administered by intravitreal injection approximately every 28 days
Primary Outcome Measure Information:
Title
Mean change from baseline in Best Corrected Visual Acuity (BCVA)
Description
BCVA measured by Early Treatment Diabetic Retinopathy Study (ETDRS)
Time Frame
At Week 54
Secondary Outcome Measure Information:
Title
Incidences of ocular and overall adverse events (AEs)
Description
Evaluate the safety and tolerability of RGX-314
Time Frame
Through Week 98
Title
Mean change from baseline in BCVA
Description
BCVA measured by ETDRS
Time Frame
At Week 98 (RGX-314 randomized participants only)
Title
Mean change from baseline in Central Retinal Thickness (CRT) and Center Point Thickness (CPT) as measured by Spectral Domain Optical Coherence Tomography (SD-OCT)
Time Frame
At Week 54 and Week 98
Title
Mean reduction in supplemental anti VEGF injection annualized rate compared with the prior 52 weeks preceding the first ranibizumab injection received as part of the Active Run-in Period (RGX 314 randomized participants)
Time Frame
Through Week 54 and Week 98
Title
Mean supplemental anti-VEGF injection annualized rate in the RGX-314 arms
Time Frame
Through Week 54 and Week 98
Title
Aqueous RGX-314 target protein (TP) concentrations
Time Frame
At Week 14, Week 26, Week 38, Week 54, and Week 98

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: CNV or macular edema in the study eye secondary to any causes other than AMD Subfoveal fibrosis or atrophy in the study eye Any condition in the investigator's opinion that could limit VA improvement in the study eye Active or history of retinal detachment in the study eye Uncontrolled glaucoma in the study eye History of intraocular surgery in the study eye within 12 weeks prior to Screening Visit 1 History of intravitreal therapy in the study eye, such as intravitreal steroid injection or investigational product, other than anti-VEGF therapy, in the 6 months prior to Screening Visit 1. Prior treatment with gene therapy. Recent myocardial infarction, cerebrovascular accident, or transient ischemic attack within the past 6 months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patient Advocacy
Phone
1-866-860-0117
Email
patientadvocacy@regenxbio.com
Facility Information:
Facility Name
Retinal Consultants of Arizona, Ltd.
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85014
Country
United States
Individual Site Status
Recruiting
Facility Name
Barnet Dulaney Perkins Eye Center - Phoenix
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina-Vitreous Associates Medical Group
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Individual Site Status
Recruiting
Facility Name
Retinal Diagnostic Center
City
Campbell
State/Province
California
ZIP/Postal Code
95008
Country
United States
Individual Site Status
Recruiting
Facility Name
The Retina Partners - Encino
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Consultants of Orange County - Fullerton Office
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California Irvine - School of Medicine - The Gavin Herbert Eye Institute
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Individual Site Status
Recruiting
Facility Name
Doheny Eye Institute - Doheny Eye Center - Arcadia
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Name
Northern California Retina Vitreous Associates Medical Group, Inc. - Mountain View Office
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Individual Site Status
Recruiting
Facility Name
California Eye Specialists Medical Group Inc. - Pasadena
City
Pasadena
State/Province
California
ZIP/Postal Code
91107
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Consultants San Diego
City
Poway
State/Province
California
ZIP/Postal Code
92064
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Consultants
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Individual Site Status
Recruiting
Facility Name
West Coast Retina Medical Group - San Francisco Office
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
San Francisco 1 Location
Facility Name
UCSF Medical Center - Retina and Vitreous Clinic
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Name
Orange County Retina Medical Group
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Individual Site Status
Recruiting
Facility Name
California Retina Consultants
City
Santa Barbara
State/Province
California
ZIP/Postal Code
85014
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Consultants of Southern Colorado PC- Colorado Springs
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Individual Site Status
Recruiting
Facility Name
Southwest Retina Consultants
City
Durango
State/Province
Colorado
ZIP/Postal Code
81301
Country
United States
Individual Site Status
Recruiting
Facility Name
Colorado Retina Associates (CRA) - Red Rocks Medical Center Location
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Group of New England - New London
City
Waterford
State/Province
Connecticut
ZIP/Postal Code
06385
Country
United States
Individual Site Status
Recruiting
Facility Name
Vitreo Retinal Associates PA - The Millennium Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Retina Consultants - Lakeland
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805-2908
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Bascom Palmer Eye Institute - University of Miami Health System
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Specialty Institute - Pensacola
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Vitreous Associates of Florida (RVA) - Saint Petersburg
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33711
Country
United States
Individual Site Status
Recruiting
Facility Name
Southern Vitreoretinal Associates, P.L.
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Southeast Retina Center
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Georgia Retina PC - Marietta
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Consultants of Hawaii (RCH) - Pali Momi Medical Center Location
City
'Aiea
State/Province
Hawaii
ZIP/Postal Code
96701
Country
United States
Individual Site Status
Recruiting
Facility Name
Illinois Eye and Ear Infirmary at UI Health UIC
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Name
University Retina and Macula Associates, P.C. - Lemont Office
City
Lemont
State/Province
Illinois
ZIP/Postal Code
60439
Country
United States
Individual Site Status
Recruiting
Facility Name
University Retina and Macula Associates, PC - Oak Forest
City
Oak Forest
State/Province
Illinois
ZIP/Postal Code
60452
Country
United States
Individual Site Status
Recruiting
Facility Name
Springfield Clinic
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Springfield Clinic
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62703
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Midwest Eye Institute
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Individual Site Status
Recruiting
Facility Name
John-Kenyon American Eye Institute - New Albany
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Associates, P.A. - Shawnee Mission
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66204
Country
United States
Individual Site Status
Recruiting
Facility Name
The Retina Care Center, LLC
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21209
Country
United States
Individual Site Status
Recruiting
Facility Name
The Johns Hopkins Hospital - Wilmer Eye Institute - East Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Name
Cumberland Valley Retina Consultants (CVRC)
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Individual Site Status
Recruiting
Facility Name
Ophthalmic Consultants of Boston, Inc.
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Associates of Michigan - Grand Blanc Office
City
Grand Blanc
State/Province
Michigan
ZIP/Postal Code
48439-8301
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Associated Retinal Consultants P.C.
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Individual Site Status
Recruiting
Facility Name
VitreoRetinal Surgery, PA - Edina Location
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Location
Facility Name
Mayo Clinic - Minnesota
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Name
Sierra Eye Associates
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Individual Site Status
Recruiting
Facility Name
Eye Associates of New Mexico - Albuquerque - Retina Center Location
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Individual Site Status
Recruiting
Facility Name
Long Island Vitreoretinal Consultants - Great Neck
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Individual Site Status
Recruiting
Facility Name
Duke Eye Center - Erwin Road - Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Individual Site Status
Recruiting
Facility Name
Wake Forest Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Cincinnati Eye Institute - Blue Ash
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Associates of Cleveland, Inc. - Middleburg Heights Office
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Individual Site Status
Recruiting
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Vitreous Center (RVC)
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73013
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Northwest, PC
City
Portland
State/Province
Oregon
ZIP/Postal Code
97221
Country
United States
Individual Site Status
Recruiting
Facility Name
Erie Retinal Surgery, Inc
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16507-1429
Country
United States
Individual Site Status
Recruiting
Facility Name
Mid Atlantic Retina - Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Name
Charleston Neuroscience Institute
City
Ladson
State/Province
South Carolina
ZIP/Postal Code
29456-4118
Country
United States
Individual Site Status
Recruiting
Facility Name
Black Hills Regional Eye Institute
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Individual Site Status
Recruiting
Facility Name
Charles Retina Institute
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Individual Site Status
Recruiting
Facility Name
West Texas Retina Consultants (WTRC) - Abilene Location
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606
Country
United States
Individual Site Status
Recruiting
Facility Name
Austin Retina Associates
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Consultants of Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Individual Site Status
Recruiting
Facility Name
Austin Clinical Research, LLC
City
Austin
State/Province
Texas
ZIP/Postal Code
78750
Country
United States
Individual Site Status
Recruiting
Facility Name
Star Retina
City
Burleson
State/Province
Texas
ZIP/Postal Code
79606
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Burleson Location
Facility Name
Texas Retina Associates
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Individual Site Status
Recruiting
Facility Name
Star Vision Consultants
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Retina Associates of South Texas, PA - San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240-1657
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Retinal Consultants of San Antonio (RCSA) - Medical Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240-1657
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Retina Center of Texas - Southlake
City
Southlake
State/Province
Texas
ZIP/Postal Code
76092
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Consultants of Texas - The Woodlands
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Associates of Utah, PC
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Individual Site Status
Recruiting
Facility Name
John A. Moran Eye Center - University of Utah Health Care
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Individual Site Status
Recruiting
Facility Name
Wagner Macula & Retina Center
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23454
Country
United States
Individual Site Status
Recruiting
Facility Name
Pacific Northwest Retina
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004-3779
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Center Northwest - Silverdale
City
Silverdale
State/Province
Washington
ZIP/Postal Code
98383-7849
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Wisconsin Health - University Station Clinic
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Pivotal 1 Study of RGX-314 Gene Therapy in Participants With nAMD

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