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Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 50 Years and 89 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 Inclusion Criteria (Bilateral Treatment Substudy)*: 1. An ETDRS BCVA letter score between ≤ 83 and ≥ 40 in both eyes 2. Diagnosis of subfoveal choroidal neovascularization (CNV) secondary to AMD in both eyes 3. Must be pseudophakic (at least 12 weeks postcataract surgery) in both eyes 4. Willing and able to provide written, signed informed consent for this study 5. Newcomers must have active disease in the study eye; crossover participants must have active disease in the eye not treated in the main study

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, as determined by CRC 3. Any condition in the investigator's opinion that could limit VA improvement in the study eye 4. Active or history of retinal detachment, or current retinal tear that cannot be treated, in the study eye 5. Advanced glaucoma or history of secondary glaucoma in the study eye 6. History of intraocular surgery in the study eye within 12 weeks prior to randomization 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 Exclusion Criteria (Bilateral Treatment Substudy)*: 1. CNV or macular edema in either eye secondary to any causes other than AMD 2. Subfoveal fibrosis or atrophy in either eye 3. Any condition in the investigator's opinion that could limit VA improvement in either eye 4. Active or history of retinal detachment, or current retinal tear that cannot be treated in either eye 5. Advanced glaucoma or history of secondary glaucoma in either eye 6. Myocardial infarction, cerebrovascular accident, or transient ischemic attack within the past 6 months 7. History of intraocular surgery in either eye within 12 weeks prior to randomization (Week -2) 8. History of intravitreal therapy in either eye, such as intravitreal steroid injection or investigational product, other than anti-VEGF therapy, in the 6 months prior to screening 9. Prior treatment with gene therapy (*) For previously treated crossover participants, criteria apply to the eye not treated in the main study only.

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
2 ABBV-RGX-314 treatment arms, 1 control arm (ranibizumab)
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
The administration of ABBV-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.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
ABBV-RGX-314 Dose 1 		ABBV-RGX-314 Dose 1 administered via subretinal delivery one time.
  • Genetic: ABBV-RGX-314
    AAV8 vector containing a transgene for anti-VEGF Fab (Dose 1)
    Other names:
    • surabgene lomparvovec
    • RGX-314
Experimental
ABBV-RGX-314 Dose 2 		ABBV-RGX-314 Dose 2 administered via subretinal delivery one time.
  • Genetic: ABBV-RGX-314
    AAV8 vector containing a transgene for anti-VEGF Fab (Dose 2)
    Other names:
    • surabgene lomparvovec
    • RGX-314
Active Comparator
Control Arm 		Ranibizumab administered via intravitreal injection approximately every 28 days
  • Biological: Ranibizumab (LUCENTIS®)
    0.5 mg (0.05 mL of 10 mg/mL solution) administered by intravitreal injection approximately every 28 days
    Other names:
    • Ranibizumab (anti-VEGF agent)

Recruiting Locations

Retinal Research Institute /ID# 256019
Phoenix, Arizona 85053
Contact:
Site Coordinator
602-222-2221

Barnet Dulaney Perkins Eye Center - Sun City /ID# 256055
Sun City, Arizona 85351

University of Arkansas for Medical Sciences /ID# 271290
Little Rock, Arkansas 72205

Retina Vitreous Assoc Med Grp /ID# 256299
Beverly Hills, California 90211

Retinal Diagnostic Center /ID# 256137
Campbell, California 95008

The Retina Partners - Encino /ID# 256054
Encino, California 91436

Retina Consultants of Orange County /ID# 256152
Fullerton, California 92835

Salehi Retina Institute /ID# 263485
Huntington Beach, California 92647

Northern California Retina Vitreous Associates Medical Group, Inc /ID# 256298
Mountain View, California 94040-4101

UCLA Doheny Eye Center /ID# 256120
Pasadena, California 91105

California Eye Specialists Medical Group Inc. /ID# 256079
Pasadena, California 91107

Retina Consultants of San Diego /ID# 256021
Poway, California 92064-2530

Retinal Consultants Medical Group /ID# 256047
Sacramento, California 95825

West Coast Retina /ID# 256448
San Francisco, California 94107

University of California, San Francisco /ID# 256130
San Francisco, California 94143

Orange County Retina Medical Group /ID# 256073
Santa Ana, California 92705

Retina Consultants of Southern Colorado /ID# 256069
Colorado Springs, Colorado 80909
Contact:
Site Coordinator
(719) 473-9595

Southwest Retina Research Center /ID# 256136
Durango, Colorado 81303

Colorado Retina Associates /ID# 256121
Lakewood, Colorado 80228

Advanced Research, LLC /ID# 275451
Deerfield Beach, Florida 33064-1342

Vitreoretinal Associates, P.A. /ID# 256150
Gainesville, Florida 32607

Florida Retina Consultants /ID# 265661
Lakeland, Florida 33805

Retina Specialty Institute /ID# 256153
Pensacola, Florida 32503
Contact:
Site Coordinator
(850) 476-6759

Retina Vitreous Associates of Florida - St. Petersburg /ID# 256050
St. Petersburg, Florida 33711-1141

Southern Vitreoretinal Associates /ID# 256158
Tallahassee, Florida 32308

Southeast Retina Center /ID# 256022
Augusta, Georgia 30909

Georgia Retina - Marietta /ID# 256142
Marietta, Georgia 30060

Marietta Eye Clinic /ID# 268163
Marietta, Georgia 30060

Thomas Eye Group PC /ID# 268159
Sandy Springs, Georgia 30328-4411

Retina Consultants of Hawaii /ID# 256049
‘Aiea, Hawaii 96701

University Retina and Macula Associates /ID# 256078
Lemont, Illinois 60439

University Retina and Macula Associates /ID# 256077
Oak Forest, Illinois 60452

Springfield Clinic /ID# 266225
Springfield, Illinois 62702-3749

Retina Partners Midwest, PC /ID# 256045
Indianapolis, Indiana 46290

John-Kenyon American Eye Institute -New Albany /ID# 256065
New Albany, Indiana 47150-3620

Retina Associates - Lenexa /ID# 256080
Lenexa, Kansas 66215

Cincinnati Eye Institute- Edgewood /ID# 256132
Edgewood, Kentucky 41017-3415

Retina Associates of New Orleans /ID# 272440
Metairie, Louisiana 70006-2940

Ochsner Medical Center - Jefferson Highway /ID# 270524
New Orleans, Louisiana 70121

The Retina Care Center /ID# 256144
Baltimore, Maryland 21209

Johns Hopkins Hospital /ID# 256015
Baltimore, Maryland 21287

The Retina Group Of Washington - Chevy Chase /ID# 276039
Chevy Chase, Maryland 20815

Cumberland Valley Retina Consultants - Hagerstown /ID# 256151
Hagerstown, Maryland 21740

Ophthalmic Consultants of Boston /ID# 256014
Boston, Massachusetts 02114

Retina Associates of Michigan /ID# 266198
Grand Blanc, Michigan 48439

Associated Retinal Consultants /ID# 256156
Royal Oak, Michigan 48073

VitreoRetinal Surgery PLLC DBA Retina Consultants of Minnesota /ID# 256160
Edina, Minnesota 55435

Mayo Clinic - Minnesota /ID# 256051
Rochester, Minnesota 55905

The Retina Institute /ID# 266587
St Louis, Missouri 46214

Sierra Eye Associates /ID# 256020
Reno, Nevada 89502

Eye Associates of New Mexico /ID# 256075
Albuquerque, New Mexico 87109

Retina-Vitreous Surgeons of Central New York - Liverpool /ID# 266274
Liverpool, New York 13088

Duke Eye Center /ID# 256076
Durham, North Carolina 27705

Atrium Health Wake Forest Baptist Medical Center /ID# 270767
Winston-Salem, North Carolina 27157

Retina Associates of Cleveland-Middleburg Heights /ID# 256052
Cleveland, Ohio 44130

Cleveland Clinic Main Campus /ID# 256064
Cleveland, Ohio 44195

Retina Vitreous Center, Research /ID# 256067
Edmond, Oklahoma 73013

Verum Research, LLC /ID# 266585
Eugene, Oregon 97401

Retina Northwest, PC /ID# 256140
Portland, Oregon 97221

Erie Retina Research /ID# 256154
Erie, Pennsylvania 16507

Retina Vitreous Consultants - Monroeville /ID# 271654
Monroeville, Pennsylvania 15146
Contact:
Site Coordinator
(412) 683-5300

Mid Atlantic Retina /ID# 256013
Philadelphia, Pennsylvania 19107

Charleston Neuroscience Institute /ID# 256235
Ladson, South Carolina 29456

Black Hills Regional Eye Institute /ID# 256161
Rapid City, South Dakota 57701

Charles Retina Institute /ID# 256016
Germantown, Tennessee 38138

Retina Research Institute of Texas /ID# 256141
Abilene, Texas 79606-1224

Austin Research Center for Retina /ID# 256148
Austin, Texas 78705

Austin Retina Associates - Austin /ID# 256053
Austin, Texas 78705

Austin Clinical Research, LLC /ID# 256043
Austin, Texas 78750-2298

Retina Consultants of Texas - Beaumont /ID# 266279
Beaumont, Texas 77707

Retina and Vitreous of Texas /ID# 263961
Bellaire, Texas 77401

Texas Retina Associates - Dallas /ID# 256133
Dallas, Texas 75231

Baylor Scott & White Surgicare /ID# 256122
Fort Worth, Texas 76104

Retina Consultants Of Texas /ID# 268611
San Antonio, Texas 78240

Retina Center Of Texas (Rct) - Southlake /ID# 256056
Southlake, Texas 76092

Retina Consultants - The Woodlands /ID# 256018
The Woodlands, Texas 77384

Retina Associates of Utah /ID# 256044
Salt Lake City, Utah 84107

John A. Moran Eye Center /ID# 256068
Salt Lake City, Utah 84132

Wagner Macula & Retina Center - Norfolk /ID# 256134
Norfolk, Virginia 23502

Retina Center NW, PLLC /ID# 256157
Silverdale, Washington 98383

More Details

NCT ID
NCT04704921
Status
Recruiting
Sponsor
AbbVie

Study Contact

Patient Advocacy
833-711-0349
patientadvocacy@regenxbio.com

Detailed Description

This randomized, partially masked, active-controlled, Phase 2b/3 clinical study will evaluate the efficacy and safety of ABBV-RGX-314 gene therapy in participants with nAMD. The study will evaluate 2 dose levels of ABBV-RGX-314 relative to an active comparator. The primary endpoint of this study is the mean change from baseline in best-corrected visual acuity (BCVA) of ABBV-RGX-314 relative to ranibizumab at Week 54. Approximately 630 participants who meet the inclusion/exclusion criteria, will be enrolled into one of 3 arms. A bilateral treatment substudy conducted at US sites is an open-label, partially randomized, parallel arm study to evaluate the safety and efficacy of subretinal ABBV-RGX-314 administered bilaterally in participants who have bilateral nAMD. Previously treated crossover participants from the control arm of the main study who crossed over and received ABBV-RGX-314 in the study eye will receive the same ABBV-RGX-314 dose in the contralateral eye (ie, same dose as in the study eye), and newcomers (participants who have not been randomized in an ABBV-RGX-314 study) and untreated crossover participants (ongoing control participants in the main study who have completed Week 54 but have not crossed over to receive ABBV-RGX-314 in the main study) will be randomized in a 2:1 ratio to receive ABBV-RGX-314 Dose 1 or ABBV-RGX-314 Dose 2 in both eyes. Up to 15 participants who qualify for the substudy will be enrolled and followed for a minimum of 50 weeks.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.