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

NCT05407636 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: RGX-314-3101M23-409
• Study Type: interventional
• Target: 714
• Locations: 10 countries
• Sites: 181

Brief Summary

ABBV-RGX-314 (also known as RGX-314 and surabgene lomparvovec (sura-vec)) 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-vascular endothelial growth factor (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. ABBV-RGX-314 is being developed as a potential one-time treatment for wet AMD.

Conditions

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; AMD; wet AMD

Outcome Measures

Primary Outcomes (2)

• Mean change from baseline in Best Corrected Visual Acuity (BCVA)

  To evaluate the noninferiority of ABBV-RGX-314 relative to aflibercept in mean change from Baseline BCVA at Week 54

  At Week 54

• Bilateral Treatment Substudy: Incidence of ocular AEs and any SAEs

  AEs and SAEs through Week 50

  Week 50

Secondary Outcomes (35)

• Incidences of ocular and overall AEs

  Through Week 54

• Proportion of participants with improved BCVA

  Week 54

• Proportion of participants with worsened BCVA

  Week 54

• Proportion of participants (1) gaining or losing greater than 0 letters; (2) maintaining vision compared with baseline as per BCVA

  Week 54

• Mean change from baseline in BCVA for participants who received 0 or more supplemental anti-VEGF injection (ABBV-RGX- 314 randomized participants)

  Week 54

Study Arms (3)

ABBV-RGX-314 Dose 1

EXPERIMENTAL

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

Genetic: ABBV-RGX-314 Dose 1

ABBV-RGX-314 Dose 2

EXPERIMENTAL

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

Genetic: ABBV-RGX-314 Dose 2

Control Arm

ACTIVE COMPARATOR

Aflibercept administered via intravitreal injection approximately every 8 weeks

Biological: Aflibercept (EYLEA®)

Interventions

Aflibercept (EYLEA®) BIOLOGICAL

2.0 mg (0.05 mLsolution) administered by intravitreal injection approximately every 8 weeks after 3 monthly injections

Also known as: Eylea (anti-VEGF agent)

Control Arm

ABBV-RGX-314 Dose 1 GENETIC

AAV8 vector containing a transgene for anti-VEGF Fab (Dose 1)

Also known as: RGX-314, surabgene lomparvovec

ABBV-RGX-314 Dose 1

ABBV-RGX-314 Dose 2 GENETIC

AAV8 vector containing a transgene for anti-VEGF Fab (Dose 2)

Also known as: RGX-314, surabgene lomparvovec

ABBV-RGX-314 Dose 2

Eligibility Criteria

• Age: 50 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 50 years and ≤ 89 years
• An ETDRS BCVA letter score between ≤ 78 and ≥ 40 in the study eye
• Diagnosis of subfoveal choroidal neovascularization (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

You may not qualify if:

• 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
• Advanced glaucoma or history of secondary glaucoma in the study eye
• Myocardial infarction, cerebrovascular accident, or transient ischemic attack within the past 6 months
• History of intraocular surgery in the study eye within 12 weeks prior to randomization
• History of intravitreal therapy in the study eye, such as intravitreal steroid injection or investigational medicinal product, other than an intravitreal therapy for AMD, in the 6 months prior to Week -6
• Prior treatment with gene therapy
• CNV or macular edema in either eye secondary to any causes other than AMD
• Subfoveal fibrosis or atrophy in either eye
• Any condition in the investigator's opinion that could limit VA improvement in either eye
• Advanced glaucoma or history of secondary glaucoma in either eye
• Myocardial infarction, cerebrovascular accident, or transient ischemic attack within the past 6 months
• History of intraocular surgery in either eye within 12 weeks prior to randomization
• History of intravitreal therapy in the study eye, such as intravitreal steroid injection or investigational medicinal product, other than an intravitreal therapy for AMD, in the 6 months prior to Week -6.

Sponsors & Collaborators

• AbbVie: lead
• REGENXBIO Inc.: collaborator

Study Sites (181)

Barnet Dulaney Eye Center-Phoenix /ID# 256340

Phoenix, Arizona, 85016, United States

RECRUITING

Retinal Research Institute /ID# 256238

Phoenix, Arizona, 85053, United States

RECRUITING

Retina Macula Institute of Arizona /ID# 271026

Scottsdale, Arizona, 85255-4134, United States

RECRUITING

California Retina Consultants - Bakersfield /ID# 256240

Bakersfield, California, 93309-1677, United States

RECRUITING

Retina Vitreous Assoc Med Grp /ID# 256246

Beverly Hills, California, 90211, United States

RECRUITING

Retinal Diagnostic Center /ID# 256262

Campbell, California, 95008, United States

RECRUITING

The Retina Partners - Encino /ID# 259660

Encino, California, 91436, United States

RECRUITING

Retina Consultants of Orange County /ID# 256267

Fullerton, California, 92835, United States

ACTIVE NOT RECRUITING

Jacobs Retina Center at UCSD/ID# 256320

La Jolla, California, 92093, United States

ACTIVE NOT RECRUITING

California Retina Consultants - Oxnard - North Ventura Road /ID# 262883

Oxnard, California, 93036, United States

RECRUITING

Byers Eye Institute Stanford /ID# 262853

Palo Alto, California, 94303, United States

RECRUITING

Retina Consultants of San Diego /ID# 256258

Poway, California, 92064-2530, United States

ACTIVE NOT RECRUITING

Kaiser Permanente - Riverside Medical Center /ID# 262413

Riverside, California, 92505, United States

RECRUITING

UC Davis Health Eye Center

Sacramento, California, 95817, United States

ACTIVE NOT RECRUITING

Retinal Consultants Medical Group, Inc. - Greenback /ID# 256353

Sacramento, California, 95841, United States

ACTIVE NOT RECRUITING

Orange County Retina Medical Group /ID# 256286

Santa Ana, California, 92705, United States

RECRUITING

Macula Retina Vitreous Center - Torrance /ID# 270247

Torrance, California, 90503, United States

RECRUITING

Bay Area Retina Associates - Walnut Creek - Lennon Lane /ID# 268513

Walnut Creek, California, 94598, United States

RECRUITING

Retina Consultants of Southern Colorado /ID# 256285

Colorado Springs, Colorado, 80909, United States

RECRUITING

Southwest Retina Research Center /ID# 256261

Durango, Colorado, 81303, United States

ACTIVE NOT RECRUITING

Colorado Retina Associates /ID# 256378

Lakewood, Colorado, 80228, United States

COMPLETED

Advanced Vision Research Institute /ID# 256380

Longmont, Colorado, 80503, United States

RECRUITING

Retina Consultants, P.C. /ID# 273610

Manchester, Connecticut, 06042-3556, United States

RECRUITING

Rand Eye Institute /ID# 256337

Deerfield Beach, Florida, 33064, United States

COMPLETED

National Ophthalmic Research Institute /ID# 256344

Fort Myers, Florida, 33912-7125, United States

ACTIVE NOT RECRUITING

Vitreoretinal Associates, P.A. /ID# 256266

Gainesville, Florida, 32607, United States

ACTIVE NOT RECRUITING

Florida Retina Consultants /ID# 256321

Lakeland, Florida, 33805, United States

RECRUITING

Florida Retina Institute - Orlando /ID# 256373

Orlando, Florida, 32806-1101, United States

RECRUITING

Retina Specialty Institute /ID# 256268

Pensacola, Florida, 32503, United States

RECRUITING

Fort Lauderdale Eye Institute /ID# 266011

Plantation, Florida, 33324, United States

COMPLETED

Retina Vitreous Associates of Florida - St. Petersburg /ID# 256279

St. Petersburg, Florida, 33711-1141, United States

RECRUITING

Center for Retina and Macular Disease /ID# 256335

Winter Haven, Florida, 33880, United States

RECRUITING

Georgia Retina - Marietta /ID# 256264

Marietta, Georgia, 30060, United States

RECRUITING

Retina Consultants of Hawaii /ID# 256278

‘Aiea, Hawaii, 96701, United States

RECRUITING

Northwestern Memorial Hospital - Department of Ophthalmology /ID# 256379

Chicago, Illinois, 60611-2987, United States

RECRUITING

University Retina and Macula Associates /ID# 256288

Lemont, Illinois, 60439, United States

ACTIVE NOT RECRUITING

University Retina and Macula Associates /ID# 256287

Oak Forest, Illinois, 60452, United States

COMPLETED

Illinois Retina Associates - Oak Park /ID# 256375

Oak Park, Illinois, 60304, United States

ACTIVE NOT RECRUITING

Springfield Clinic - First /ID# 256371

Springfield, Illinois, 62702, United States

RECRUITING

Retina Partners Midwest, PC /ID# 256277

Indianapolis, Indiana, 46290, United States

RECRUITING

John-Kenyon American Eye Institute -New Albany /ID# 256283

New Albany, Indiana, 47150, United States

ACTIVE NOT RECRUITING

Wolfe Eye Clinic - West Des Moines /ID# 256314

West Des Moines, Iowa, 50266, United States

ACTIVE NOT RECRUITING

Retina Associates - Lenexa /ID# 258296

Lenexa, Kansas, 66215, United States

RECRUITING

Maine Eye Center - Marginal Way Campus /ID# 256391

Portland, Maine, 04101, United States

RECRUITING

Retina Specialists /ID# 256392

Baltimore, Maryland, 21204, United States

ACTIVE NOT RECRUITING

Johns Hopkins Hospital /ID# 256236

Baltimore, Maryland, 21287, United States

COMPLETED

Mid Atlantic Retina Specialists - Hagerstown /ID# 256310

Hagerstown, Maryland, 21740-5965, United States

ACTIVE NOT RECRUITING

MA Eye & Ear Infirmary /ID# 262430

Boston, Massachusetts, 02114, United States

ACTIVE NOT RECRUITING

Ophthalmic Consultants of Boston /ID# 256233

Boston, Massachusetts, 02114, United States

RECRUITING

Vitreo Retinal Associates - Worcester /ID# 266008

Worcester, Massachusetts, 01605, United States

RECRUITING

Retina Associates of Michigan /ID# 256393

Grand Blanc, Michigan, 48439, United States

RECRUITING

Associated Retinal Consultants /ID# 256269

Royal Oak, Michigan, 48073, United States

RECRUITING

VitreoRetinal Surgery PLLC DBA Retina Consultants of Minnesota /ID# 256272

Edina, Minnesota, 55435, United States

RECRUITING

Mayo Clinic - Rochester /ID# 258295

Rochester, Minnesota, 55905-0001, United States

RECRUITING

Mississippi Retina Associates /ID# 270934

Madison, Mississippi, 39110-2028, United States

RECRUITING

Mid America Surgery Center /ID# 258993

Chesterfield, Missouri, 63017, United States

COMPLETED

University of Missouri Hospital /ID# 262474

Columbia, Missouri, 65212, United States

RECRUITING

Washington University School of Medicine - St. Louis /ID# 256383

St Louis, Missouri, 63108, United States

RECRUITING

Sierra Eye Associates /ID# 256239

Reno, Nevada, 89502, United States

COMPLETED

Envision Ocular, LLC /ID# 256367

Bloomfield, New Jersey, 07003, United States

RECRUITING

Monmouth Retina Consultants /ID# 275895

Little Silver, New Jersey, 07739, United States

RECRUITING

Columbia University of New York - Edward S. Harkness Eye Institute /ID# 256342

New York, New York, 10032, United States

ACTIVE NOT RECRUITING

Retina Associates of Western New York /ID# 256374

Rochester, New York, 14620, United States

COMPLETED

Asheville Eye Associates- Retina Division /ID# 256355

Asheville, North Carolina, 28803, United States

RECRUITING

Duke University Medical Center /ID# 256245

Durham, North Carolina, 27710, United States

RECRUITING

Graystone Eye /ID# 256424

Hickory, North Carolina, 28602, United States

RECRUITING

Cincinnati Eye Institute /ID# 256247

Cincinnati, Ohio, 45242-5664, United States

RECRUITING

Retina Associates of Cleveland-Middleburg Heights /ID# 256280

Cleveland, Ohio, 44130, United States

ACTIVE NOT RECRUITING

Cleveland Clinic - Cleveland /ID# 256282

Cleveland, Ohio, 44195, United States

ACTIVE NOT RECRUITING

Ohio State University /ID# 256275

Columbus, Ohio, 43210, United States

RECRUITING

Midwest Retina /ID# 276644

Dublin, Ohio, 43016, United States

COMPLETED

Retina Vitreous Center, Research /ID# 256284

Edmond, Oklahoma, 73013, United States

RECRUITING

University of Pennsylvania /ID# 258995

Philadelphia, Pennsylvania, 19104-5502, United States

ACTIVE NOT RECRUITING

Mid Atlantic Retina /ID# 256232

Philadelphia, Pennsylvania, 19107, United States

ACTIVE NOT RECRUITING

University of Pittsburgh Medical Center /ID# 258994

Pittsburgh, Pennsylvania, 15213, United States

ACTIVE NOT RECRUITING

Charleston Neuroscience Institute - Beaufort /ID# 256385

Beaufort, South Carolina, 29902-6216, United States

RECRUITING

Charleston Neurosciences Institute /ID# 256351

Charleston, South Carolina, 29414-5896, United States

RECRUITING

Palmetto Retina Center-Florence /ID# 256244

Florence, South Carolina, 29501, United States

COMPLETED

Charleston Neurosciences Institute /ID# 256336

Ladson, South Carolina, 29414-5896, United States

RECRUITING

Black Hills Regional Eye Institute /ID# 262872

Rapid City, South Dakota, 57701, United States

RECRUITING

Southeastern Retina Associates - Chattanooga /ID# 258992

Chattanooga, Tennessee, 37421, United States

COMPLETED

Charles Retina Institute /ID# 256237

Germantown, Tennessee, 38138, United States

COMPLETED

Southeastern Retina Associates - Johnson City /ID# 256396

Johnson City, Tennessee, 37604, United States

RECRUITING

Tennessee Retina - Nashville /ID# 256388

Nashville, Tennessee, 37203-1513, United States

RECRUITING

Vanderbilt University Medical Center /ID# 256372

Nashville, Tennessee, 37232-0011, United States

RECRUITING

Retina Research Institute of Texas /ID# 256263

Abilene, Texas, 79606-1224, United States

COMPLETED

Austin Research Center for Retina /ID# 256265

Austin, Texas, 78705, United States

RECRUITING

Austin Clinical Research, LLC /ID# 256274

Austin, Texas, 78750-2298, United States

COMPLETED

Retina Consultants of Texas - Bellaire /ID# 256377

Bellaire, Texas, 77401, United States

RECRUITING

Star Retina - Burleson /ID# 256376

Burleson, Texas, 76028, United States

ACTIVE NOT RECRUITING

Texas Retina Associates /ID# 256259

Dallas, Texas, 75231, United States

RECRUITING

Texas Retina Associates - Fort Worth /ID# 256326

Fort Worth, Texas, 76104, United States

RECRUITING

Austin Retina Associates - Round Rock /ID# 256387

Round Rock, Texas, 78681, United States

RECRUITING

Retina Consultants of Texas/ID# 259661

San Antonio, Texas, 78240-1655, United States

RECRUITING

Retina Associates of South Texas

San Antonio, Texas, 78240, United States

RECRUITING

Retina Consultants of Texas /ID# 256382

San Antonio, Texas, 78251, United States

RECRUITING

Retina Center Of Texas (Rct) - Southlake /ID# 256281

Southlake, Texas, 76092, United States

RECRUITING

Rocky Mountain Retina Consultants /ID# 256369

Murray, Utah, 84107, United States

ACTIVE NOT RECRUITING

Retina Associates of Utah /ID# 256276

Salt Lake City, Utah, 84107, United States

RECRUITING

Piedmont Eye Center /ID# 256386

Lynchburg, Virginia, 24502, United States

COMPLETED

Wagner Kapoor Research Institute - Norfolk /ID# 256260

Norfolk, Virginia, 23502, United States

COMPLETED

Retina Institute of Virginia /ID# 256394

Richmond, Virginia, 23235, United States

COMPLETED

Vistar Eye Center /ID# 271024

Roanoke, Virginia, 24019, United States

RECRUITING

Pacific Northwest Retina /ID# 258999

Bellevue, Washington, 98004, United States

COMPLETED

Retina Center NW, PLLC /ID# 256395

Silverdale, Washington, 98383, United States

RECRUITING

Spokane Eye Clinic /ID# 256338

Spokane, Washington, 99204, United States

ACTIVE NOT RECRUITING

Gundersen Health System - La Crosse Medical Center /ID# 276012

La Crosse, Wisconsin, 54601, United States

RECRUITING

Calgary Retina Consultants /ID# 258997

Calgary, Alberta, T2H 0C8, Canada

ACTIVE NOT RECRUITING

Alberta Retina Consultants /ID# 265599

Edmonton, Alberta, T5H 0X5, Canada

ACTIVE NOT RECRUITING

Retina Surgical Associates /ID# 270958

New Westminster, British Columbia, V3L 5H1, Canada

ACTIVE NOT RECRUITING

University of British Columbia - Eye Care Centre, Vancouver General Hospital /ID# 266014

Vancouver, British Columbia, V5Z 3N9, Canada

COMPLETED

Vitreous Retina Macula Specialists of Toronto /ID# 258299

Etobicoke, Ontario, M8X 2X3, Canada

ACTIVE NOT RECRUITING

Ottawa Hospital Research Institute /ID# 258998

Ottawa, Ontario, K1H 8L6, Canada

ACTIVE NOT RECRUITING

Retina Centre of Ottawa /ID# 259659

Ottawa, Ontario, K2B 7E9, Canada

ACTIVE NOT RECRUITING

Toronto Retina Institute /ID# 265602

Toronto, Ontario, M3C 0G9, Canada

ACTIVE NOT RECRUITING

Sunnybrook Research Institute /ID# 270690

Toronto, Ontario, M4N 3M5, Canada

ACTIVE NOT RECRUITING

CHU de Quebec-Universite Laval /ID# 258996

Québec, Quebec, G1R 2J6, Canada

COMPLETED

Centre Hospitalier Universitaire de Nice - Hopital Pasteur /ID# 262418

Nice, Alpes-Maritimes, 06001, France

ACTIVE NOT RECRUITING

Hôpital de la Croix Rousse - Groupement Hospitalier Nord /ID# 262409

Lyon, Auvergne-Rhône-Alpes, 69004, France

ACTIVE NOT RECRUITING

CHU Dijon /ID# 262410

Dijon, Cote-d Or, 21000, France

ACTIVE NOT RECRUITING

Chu De Toulouse - Hopital Pierre Paul Ricquet /ID# 262411

Toulouse, Occitanie, 31059, France

ACTIVE NOT RECRUITING

Hopitaux Universitaires Paris Centre-Hopital Cochin /ID# 262415

Paris, Paris, 75679, France

ACTIVE NOT RECRUITING

Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 262408

Nantes, Pays de la Loire Region, 44000, France

ACTIVE NOT RECRUITING

Clinique Juge /ID# 262417

Marseille, Provence-Alpes-Côte d'Azur Region, 13008, France

ACTIVE NOT RECRUITING

Centre Hosp Intercommunal de Creteil /ID# 262407

Créteil, Val-de-Marne, 94000, France

ACTIVE NOT RECRUITING

Clinique Honoré Cave /ID# 262225

Montauban, 82017, France

ACTIVE NOT RECRUITING

AP-HP - Groupe Hospitalier 10e - Hopital Lariboisiere /ID# 262406

Paris, 75010, France

ACTIVE NOT RECRUITING

Universitaetsklinikum Freiburg /ID# 262495

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

ACTIVE NOT RECRUITING

Universitaetsklinikum Ulm /ID# 262494

Ulm, Baden-Wurttemberg, 89081, Germany

ACTIVE NOT RECRUITING

Universitaetsklinikum Bonn /ID# 262498

Bonn, North Rhine-Westphalia, 53127, Germany

ACTIVE NOT RECRUITING

Universitaetsklinikum Muenster /ID# 262499

Münster, North Rhine-Westphalia, 48149, Germany

ACTIVE NOT RECRUITING

Klinikum Ludwigshafen /ID# 262497

Ludwigshafen am Rhein, Rhineland-Palatinate, 67063, Germany

ACTIVE NOT RECRUITING

Universitaetsklinikum Hamburg-Eppendorf /ID# 262493

Hamburg, 20246, Germany

ACTIVE NOT RECRUITING

Knappschaftsklinikum Saar /ID# 262496

Püttlingen, 66346, Germany

COMPLETED

Debreceni Egyetem-Klinikai Kozpont /ID# 262646

Debrecen, Hajdú-Bihar, 4032, Hungary

ACTIVE NOT RECRUITING

Budapest Retina Intezet /ID# 262647

Budapest, 1133, Hungary

ACTIVE NOT RECRUITING

Ganglion Orvosi Központ /ID# 264550

Pécs, 7621, Hungary

ACTIVE NOT RECRUITING

Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale S.Anna /ID# 262896

Cona, Ferrara, 44124, Italy

ACTIVE NOT RECRUITING

IRCCS Ospedale San Raffaele /ID# 263035

Milan, Milano, 20132, Italy

ACTIVE NOT RECRUITING

ASST Fatebenefratelli Sacco /ID# 263273

Milan, Milano, 20157, Italy

ACTIVE NOT RECRUITING

Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 264074

Naples, Napoli, 80138, Italy

ACTIVE NOT RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 263037

Rome, Roma, 00168, Italy

ACTIVE NOT RECRUITING

IRCCS Fondazione G.B. Bietti per lo studio e la ricerca in Oftalmologia- ONLUS /ID# 262897

Rome, Roma, 00184, Italy

COMPLETED

IRCCS Ospedale Sacro Cuore Don Calabria /ID# 263536

Negrar, Verona, 37024, Italy

COMPLETED

A.O.U. Consorziale Policlinico di Bari /ID# 262500

Bari, 70124, Italy

ACTIVE NOT RECRUITING

ASL 2 Abruzzo Lanciano-Vasto-Chieti /ID# 263923

Chieti, 67100, Italy

ACTIVE NOT RECRUITING

ASU FC - P.O. Universitario Santa Maria della Misericordia /ID# 263036

Udine, 33100, Italy

ACTIVE NOT RECRUITING

Nagoya University Hospital /ID# 267350

Nagoya, Aichi-ken, 466-8560, Japan

RECRUITING

Fukushima Medical University Hospital /ID# 258411

Fukushima, Fukushima, 960-1295, Japan

RECRUITING

Kobe City Eye Hospital /ID# 256948

Kobe, Hyōgo, 650-0047, Japan

RECRUITING

Hyogo Medical University Hospital /ID# 257893

Nishinomiya-shi, Hyōgo, 663-8501, Japan

RECRUITING

Kagoshima University Hospital /ID# 257053

Kagoshima, Kagoshima-ken, 890-8520, Japan

RECRUITING

Kyoto University Hospital /ID# 267351

Kyoto, Kyoto, 606-8507, Japan

RECRUITING

University of Miyazaki Hospital /ID# 262879

Miyazaki, Miyazaki, 889-1692, Japan

RECRUITING

Shiga University of Medical Science /ID# 266862

Ōtsu, Shiga, 520-2192, Japan

RECRUITING

Juntendo University Hospital /ID# 258715

Bunkyo-ku, Tokyo, 113-8431, Japan

RECRUITING

Emanuelli Research & Development Center LLC /ID# 256231

Arecibo, 00612, Puerto Rico

ACTIVE NOT RECRUITING

Complejo Hospitalario Universitario de Santiago (CHUS) /ID# 262632

Santiago de Compostela, A Coruna, 15706, Spain

ACTIVE NOT RECRUITING

Hospital Universitari de Bellvitge /ID# 262641

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

ACTIVE NOT RECRUITING

Hospital Arruzafa /ID# 262634

Córdoba, Cordoba, 14012, Spain

ACTIVE NOT RECRUITING

Complejo Hospitalario Universitario Insular-Materno Infantil de Gran Canaria /ID# 262633

Las Palmas de Gran Canaria, Las Palmas, 35016, Spain

ACTIVE NOT RECRUITING

Hospital Universitario Puerta de Hierro - Majadahonda /ID# 262635

Majadahonda, Madrid, 28222, Spain

ACTIVE NOT RECRUITING

Institut Clínic d'Oftalmologia (ICOF). Hospital Clínic d'Oftalmologia. /ID# 262644

Barcelona, 08028, Spain

COMPLETED

Instituto de Microcirugía Ocular /ID# 262642

Barcelona, 08035, Spain

COMPLETED

Hospital Santa Creu i Sant Pau /ID# 262637

Barcelona, 08041, Spain

ACTIVE NOT RECRUITING

Hospital Universitario 12 de Octubre /ID# 262636

Madrid, 28041, Spain

ACTIVE NOT RECRUITING

Clinica Baviera /ID# 270146

Madrid, 28046, Spain

COMPLETED

Stoke Mandeville Hospital /ID# 277343

Aylesbury, Buckinghamshire, HP21 8AL, United Kingdom

ACTIVE NOT RECRUITING

Western Eye Hospital /ID# 271621

London, England, NW1 5QH, United Kingdom

ACTIVE NOT RECRUITING

Gloucestershire Royal Hospital /ID# 277362

Gloucester, Gloucestershire, GL1 3NN, United Kingdom

COMPLETED

Moorfields Eye Hospital /ID# 263038

London, Greater London, EC1V 2PD, United Kingdom

COMPLETED

The Retina Clinic London /ID# 262304

London, Greater London, W1G 7LB, United Kingdom

ACTIVE NOT RECRUITING

University Hospital Southampton NHS Foundation Trust /ID# 262307

Southampton, Hampshire, SO16 6YD, United Kingdom

ACTIVE NOT RECRUITING

Oxford University Hospitals NHS Foundation Trust /ID# 262306

Oxford, Oxfordshire, OX3 9DU, United Kingdom

ACTIVE NOT RECRUITING

Leeds Teaching Hospital /ID# 277366

Leeds, West Yorkshire, LS9 7TF, United Kingdom

COMPLETED

Bradford Royal Infirmary /ID# 273164

Bradford, BD9 6RJ, United Kingdom

ACTIVE NOT RECRUITING

Bristol Eye Hospital /ID# 271619

Bristol, BS1 2LX, United Kingdom

COMPLETED

Liverpool University Hospitals NHS Foundation Trust /ID# 262305

Liverpool, L7 8XP, United Kingdom

ACTIVE NOT RECRUITING

Manchester University NHS Foundation Trust /ID# 262404

Manchester, M9 2AA, United Kingdom

COMPLETED

Royal Victoria Infirmary /ID# 277368

Newcastle upon Tyne, NE1 4LP, United Kingdom

ACTIVE NOT RECRUITING

Sunderland Eye Infirmary /ID# 271620

Sunderland, SR2 9HP, United Kingdom

COMPLETED

Related Links

• Related Info

MeSH Terms

Conditions

Macular Degeneration; Wet Macular Degeneration; Choroidal Neovascularization; Retinal Degeneration; Retinal Diseases; Eye Diseases

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Choroid Diseases; Uveal Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Eye Diseases, Hereditary

Central Study Contacts

Patient Advocacy

CONTACT

1-833-711-0349; Patientadvocacy@regenxbio.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: ABBV-RGX-314 administration is performed as an outpatient surgical procedure in an operating room, while the active control, aflibercept, 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 2 ABBV-RGX-314 treatment arms, 1 control arm (aflibercept)

Study Record Dates

• First Submitted: January 28, 2022
• First Posted: June 7, 2022
• Study Start: January 13, 2022
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

PR (1); IT (10); JP (9); GB (14); US (107); FR (10); ES (10); HU (3); DE (7); CA (10)