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Pivotal 2 Study of RGX-314 Gene Therapy in Participants With nAMD (ASCENT)

Primary Purpose

AMD, nAMD, Wet Age-related Macular Degeneration

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
RGX-314 Dose 1
RGX-314 Dose 2
Aflibercept (EYLEA®)
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, Aflibercept, 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

  • Barnet Dulaney Perkins Eye CenterRecruiting
  • Retinal Consultants of ArizonaRecruiting
  • Retinal Research InstituteRecruiting
  • California Retina ConsultantsRecruiting
  • Retina Vitreous Associates Medical GroupRecruiting
  • Retinal Diagnostic CenterRecruiting
  • The Retina PartnersRecruiting
  • UC San DiegoRecruiting
  • Retina Consultants of San DiegoRecruiting
  • Retinal Consultants Medical Group, IncRecruiting
  • UC DavisRecruiting
  • Orange County Retina Medical GroupRecruiting
  • Retina Consultants of Southern Colorado P.C.Recruiting
  • Southwest Retina ConsultantsRecruiting
  • Colorado Retina AssociatesRecruiting
  • Eye Care Center of Northern ColoradoRecruiting
  • National Ophthalmic Research InstituteRecruiting
  • Vitreo Retinal Associates PARecruiting
  • Florida Retina ConsultantsRecruiting
  • Florida Retina InstituteRecruiting
  • Retina Specialty InstituteRecruiting
  • Rand Eye InstituteRecruiting
  • Retina Vitreous Associates of Florida - Saint PetersburgRecruiting
  • Center for Retina and Macular DiseaseRecruiting
  • Georgia Retina PCRecruiting
  • Retina Consultants of HawaiiRecruiting
  • University Retina and Macula Associates, P.C.Recruiting
  • University Retina and Macula Associates, P.C.Recruiting
  • Illinois Retina AssociatesRecruiting
  • Springfield ClinicRecruiting
  • MidWest Eye InstituteRecruiting
  • John-Kenyon American Eye InstituteRecruiting
  • Wolfe Eye ClinicRecruiting
  • Maine Eye CenterRecruiting
  • Retina SpecialistsRecruiting
  • Johns Hopkins UniversityRecruiting
  • Wilmer Eye InstituteRecruiting
  • Mid Atlantic Reina SpecialistsRecruiting
  • Massachusetts Eye and Ear InfirmaryRecruiting
  • Ophthalmic Consultants of Boston, IncRecruiting
  • Retina Associates of MichiganRecruiting
  • Associated Retinal ConsultantsRecruiting
  • Vitreo Retinal Surgery, PARecruiting
  • Sierra Eye AssociatesRecruiting
  • Envision Ocular, LLCRecruiting
  • Columbia University Irving Medical Center - Harness Eye InstituteRecruiting
  • Retina Associates of Western New YorkRecruiting
  • Western Carolina Retina Associates P.A.Recruiting
  • Duke Eye CenterRecruiting
  • Greystone EyeRecruiting
  • Cincinnati Eye InstituteRecruiting
  • Retina Associates of Cleveland, Inc.Recruiting
  • Cleveland ClinicRecruiting
  • The Ohio State University Eye & Ear InstituteRecruiting
  • Retina Vitreous Center ResearchRecruiting
  • Scheie Eye InstituteRecruiting
  • Mid Atlantic RetinaRecruiting
  • University of Pittsburgh Medical CenterRecruiting
  • Retina Consultants of CharlestonRecruiting
  • Retina Consulants of CharlestonRecruiting
  • Palmetto Retina Center LLCRecruiting
  • Retina Consultants of CharlestonRecruiting
  • Southeastern Retina AssociatesRecruiting
  • Charles Retina InstituteRecruiting
  • Southeastern Retina AssociatesRecruiting
  • Tennessee Retina Center MurfreesboroRecruiting
  • Vanderbilt University Medical CenterRecruiting
  • Retina Research Institute of TexasRecruiting
  • West Texas Retina Consultants - AbileneRecruiting
  • Texas Retina AssociatesRecruiting
  • Retina Consultants of AustinRecruiting
  • Austin Clinical Research, LLCRecruiting
  • Retina Consultants of TexasRecruiting
  • Star RetinaRecruiting
  • Ophthalmology Surgery Center of DallasRecruiting
  • Texas Retina AssociatesRecruiting
  • Austin Retina AssociatesRecruiting
  • Retina Associates of South Texas, P.A.Recruiting
  • Retina Consultants of TexasRecruiting
  • Brown Retina InstituteRecruiting
  • Retina Center of Texas - SouthlakeRecruiting
  • Rocky Mountain Retina ConsultantsRecruiting
  • Piedmont Eye CenterRecruiting
  • Wagner Macula & Retina CenterRecruiting
  • Retina Institute of VirginiaRecruiting
  • Pacific Northwest RetinaRecruiting
  • Vitreoretinal Associates of WashingtonRecruiting
  • Retina Center NorthwestRecruiting
  • Spokane Eye Clinical ResearchRecruiting
  • Calgary Retina ConsultantsRecruiting
  • Alberta Retina Research CorporationRecruiting
  • Retina Centre of OttawaRecruiting
  • CHU de Quebec-Universite LavalRecruiting
  • Emanuelli Research and Development CenterRecruiting

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.

Aflibercept administered via intravitreal injection approximately every 8 weeks

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 Serious Adverse Events (SAEs)
Incidences of ocular and overall Serious Adverse Events
Mean change from baseline in BCVA
BCVA measured by ETDRS
Mean change from baseline in CRT and CPT as measured by SD-OCT
CRT and CPT as measured by SD-OCT
Mean reduction in supplemental anti VEGF injection annualized rate compared with the prior year of therapy
Supplemental anti-VEGF treatments required post therapy to the year prior
Mean supplemental anti VEGF injection annualized rate in the RGX-314 arms
Supplemental anti-VEGF treatments required post therapy to the year prior
Aqueous RGX-314 TP concentrations
Observation of concentration of RGX-314 in the aqueous humor over time

Full Information

First Posted
January 28, 2022
Last Updated
August 17, 2023
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT05407636
Brief Title
Pivotal 2 Study of RGX-314 Gene Therapy in Participants With nAMD
Acronym
ASCENT
Official Title
A Randomized, Partially Masked, Controlled, Phase 3 Clinical Study to Evaluate the Efficacy and Safety of RGX-314 Gene Therapy in Participants With nAMD
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 28, 2021 (Actual)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
December 2025 (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 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 gene therapy 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 aflibercept. Approximately 465 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, WetAMD, 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, Aflibercept, 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 3
Interventional Study Model
Parallel Assignment
Model Description
2 RGX-314 treatment arms, 1 control arm (aflibercept)
Masking
Participant
Masking Description
Care Provider, Investigator, Outcomes Assessor
Allocation
Randomized
Enrollment
465 (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
Aflibercept administered via intravitreal injection approximately every 8 weeks
Intervention Type
Genetic
Intervention Name(s)
RGX-314 Dose 1
Intervention Description
AAV8 vector containing a transgene for anti-VEGF Fab (Dose 1)
Intervention Type
Genetic
Intervention Name(s)
RGX-314 Dose 2
Intervention Description
AAV8 vector containing a transgene for anti-VEGF Fab (Dose 2)
Intervention Type
Biological
Intervention Name(s)
Aflibercept (EYLEA®)
Intervention Description
2.0 mg (0.05 mLsolution) administered by intravitreal injection approximately every 8 weeks after 3 monthly injections Other Names: • Eylea (anti-VEGF agent)
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 Serious Adverse Events (SAEs)
Description
Incidences of ocular and overall Serious Adverse Events
Time Frame
At Week 54
Title
Mean change from baseline in BCVA
Description
BCVA measured by ETDRS
Time Frame
At Week 54 (RGX-314 randomized participants only)
Title
Mean change from baseline in CRT and CPT as measured by SD-OCT
Description
CRT and CPT as measured by SD-OCT
Time Frame
At Week 54 and Week 90
Title
Mean reduction in supplemental anti VEGF injection annualized rate compared with the prior year of therapy
Description
Supplemental anti-VEGF treatments required post therapy to the year prior
Time Frame
Through Week 54 and Week 108
Title
Mean supplemental anti VEGF injection annualized rate in the RGX-314 arms
Description
Supplemental anti-VEGF treatments required post therapy to the year prior
Time Frame
Through Week 54 and Week 108
Title
Aqueous RGX-314 TP concentrations
Description
Observation of concentration of RGX-314 in the aqueous humor over time
Time Frame
At Week 14, Week 38, Week 54, Week 74, Week 90 and Week 108

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 or current retinal tear in the study eye Advanced glaucoma or history of secondary glaucoma in the study eye Myocardial infarction, cerebrovascular accident, or transient ischemic attach within the past 6 months. 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.
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
Barnet Dulaney Perkins Eye Center
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Individual Site Status
Recruiting
Facility Name
Retinal Consultants of Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85014
Country
United States
Individual Site Status
Recruiting
Facility Name
Retinal Research Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85053
Country
United States
Individual Site Status
Recruiting
Facility Name
California Retina Consultants
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
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
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Individual Site Status
Recruiting
Facility Name
UC San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Consultants of San Diego
City
Poway
State/Province
California
ZIP/Postal Code
92064
Country
United States
Individual Site Status
Recruiting
Facility Name
Retinal Consultants Medical Group, Inc
City
Sacramento
State/Province
California
ZIP/Postal Code
85841
Country
United States
Individual Site Status
Recruiting
Facility Name
UC Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
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
Retina Consultants of Southern Colorado P.C.
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
81303
Country
United States
Individual Site Status
Recruiting
Facility Name
Colorado Retina Associates
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Individual Site Status
Recruiting
Facility Name
Eye Care Center of Northern Colorado
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80503
Country
United States
Individual Site Status
Recruiting
Facility Name
National Ophthalmic Research Institute
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Individual Site Status
Recruiting
Facility Name
Vitreo Retinal Associates PA
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Retina Consultants
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Retina Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Specialty Institute
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Individual Site Status
Recruiting
Facility Name
Rand Eye Institute
City
Pompano Beach
State/Province
Florida
ZIP/Postal Code
33064
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Vitreous Associates of Florida - Saint Petersburg
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33711
Country
United States
Individual Site Status
Recruiting
Facility Name
Center for Retina and Macular Disease
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
Individual Site Status
Recruiting
Facility Name
Georgia Retina PC
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Consultants of Hawaii
City
'Aiea
State/Province
Hawaii
ZIP/Postal Code
96701
Country
United States
Individual Site Status
Recruiting
Facility Name
University Retina and Macula Associates, P.C.
City
Lemont
State/Province
Illinois
ZIP/Postal Code
60439
Country
United States
Individual Site Status
Recruiting
Facility Name
University Retina and Macula Associates, P.C.
City
Oak Forest
State/Province
Illinois
ZIP/Postal Code
60452
Country
United States
Individual Site Status
Recruiting
Facility Name
Illinois Retina Associates
City
Oak Park
State/Province
Illinois
ZIP/Postal Code
60304
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
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
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Individual Site Status
Recruiting
Facility Name
Wolfe Eye Clinic
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Individual Site Status
Recruiting
Facility Name
Maine Eye Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04101
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Specialists
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Individual Site Status
Recruiting
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Name
Wilmer Eye Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Name
Mid Atlantic Reina Specialists
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Individual Site Status
Recruiting
Facility Name
Massachusetts Eye and Ear Infirmary
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
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
City
Grand Blanc
State/Province
Michigan
ZIP/Postal Code
48439
Country
United States
Individual Site Status
Recruiting
Facility Name
Associated Retinal Consultants
City
Novi
State/Province
Michigan
ZIP/Postal Code
48375
Country
United States
Individual Site Status
Recruiting
Facility Name
Vitreo Retinal Surgery, PA
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
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
Envision Ocular, LLC
City
Bloomfield
State/Province
New Jersey
ZIP/Postal Code
07003
Country
United States
Individual Site Status
Recruiting
Facility Name
Columbia University Irving Medical Center - Harness Eye Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Associates of Western New York
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Individual Site Status
Recruiting
Facility Name
Western Carolina Retina Associates P.A.
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Individual Site Status
Recruiting
Facility Name
Duke Eye Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Individual Site Status
Recruiting
Facility Name
Greystone Eye
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28602
Country
United States
Individual Site Status
Recruiting
Facility Name
Cincinnati Eye Institute
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Associates of Cleveland, Inc.
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
44915
Country
United States
Individual Site Status
Recruiting
Facility Name
The Ohio State University Eye & Ear Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Vitreous Center Research
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73013
Country
United States
Individual Site Status
Recruiting
Facility Name
Scheie Eye Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Name
Mid Atlantic Retina
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Consultants of Charleston
City
Beaufort
State/Province
South Carolina
ZIP/Postal Code
29902
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Consulants of Charleston
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Individual Site Status
Recruiting
Facility Name
Palmetto Retina Center LLC
City
Florence
State/Province
South Carolina
ZIP/Postal Code
29501
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Consultants of Charleston
City
Ladson
State/Province
South Carolina
ZIP/Postal Code
29456
Country
United States
Individual Site Status
Recruiting
Facility Name
Southeastern Retina Associates
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
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
Southeastern Retina Associates
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37604
Country
United States
Individual Site Status
Recruiting
Facility Name
Tennessee Retina Center Murfreesboro
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Research Institute of Texas
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606-1224
Country
United States
Individual Site Status
Recruiting
Facility Name
West Texas Retina Consultants - Abilene
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Retina Associates
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
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
Retina Consultants of Texas
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Individual Site Status
Recruiting
Facility Name
Star Retina
City
Burleson
State/Province
Texas
ZIP/Postal Code
76028
Country
United States
Individual Site Status
Recruiting
Facility Name
Ophthalmology Surgery Center of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Retina Associates
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Individual Site Status
Recruiting
Facility Name
Austin Retina Associates
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Associates of South Texas, P.A.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Consultants of Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Individual Site Status
Recruiting
Facility Name
Brown Retina Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78251
Country
United States
Individual Site Status
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
Rocky Mountain Retina Consultants
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Individual Site Status
Recruiting
Facility Name
Piedmont Eye Center
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24502
Country
United States
Individual Site Status
Recruiting
Facility Name
Wagner Macula & Retina Center
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Institute of Virginia
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23235
Country
United States
Individual Site Status
Recruiting
Facility Name
Pacific Northwest Retina
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Individual Site Status
Recruiting
Facility Name
Vitreoretinal Associates of Washington
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Center Northwest
City
Silverdale
State/Province
Washington
ZIP/Postal Code
98383
Country
United States
Individual Site Status
Recruiting
Facility Name
Spokane Eye Clinical Research
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Individual Site Status
Recruiting
Facility Name
Calgary Retina Consultants
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2H 0C8
Country
Canada
Individual Site Status
Recruiting
Facility Name
Alberta Retina Research Corporation
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5H 0X5
Country
Canada
Individual Site Status
Recruiting
Facility Name
Retina Centre of Ottawa
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K2B 7E9
Country
Canada
Individual Site Status
Recruiting
Facility Name
CHU de Quebec-Universite Laval
City
Québec
ZIP/Postal Code
G1S 4L8
Country
Canada
Individual Site Status
Recruiting
Facility Name
Emanuelli Research and Development Center
City
Arecibo
ZIP/Postal Code
00612
Country
Puerto Rico
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Pivotal 2 Study of RGX-314 Gene Therapy in Participants With nAMD

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