AzTrials
AzTrials

AMDPhase 3ASCENTNCT05407636

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

A Phase 3 study testing ABBV-RGX-314 Dose 1, ABBV-RGX-314 Dose 2 and Aflibercept (EYLEA®) in people with AMD and nAMD, run by AbbVie at 181 sites in 10 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 50 to 89 years
Conditions the study is for
AMD, nAMD, Wet Age-related Macular Degeneration
What is being tested?
ABBV-RGX-314 Dose 1, ABBV-RGX-314 Dose 2 and Aflibercept (EYLEA®)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
735 participants
Where
181 sitesin 10 countries
Study dates
13 Jan 2022to Nov 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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.
  • Prior treatment with gene therapy (*) For previously treated crossover participants, criteria apply to the eye not treated in the main study only.
  • Note: Other inclusion/exclusion criteria apply

Trial locations and contacts

181 sites in 10 countries.

181 sites in 10 countries

United States107 sites

  • Retina Consultants of Hawaii /ID# 256278

    ‘Aiea, Hawaii, 96701

  • Retina Research Institute of Texas /ID# 256263

    Abilene, Texas, 79606-1224

  • Asheville Eye Associates- Retina Division /ID# 256355

    Asheville, North Carolina, 28803

  • Austin Research Center for Retina /ID# 256265

    Austin, Texas, 78705

  • Austin Clinical Research, LLC /ID# 256274

    Austin, Texas, 78750-2298

  • California Retina Consultants - Bakersfield /ID# 256240

    Bakersfield, California, 93309-1677

  • Retina Specialists /ID# 256392

    Baltimore, Maryland, 21204

  • Johns Hopkins Hospital /ID# 256236

    Baltimore, Maryland, 21287

  • Charleston Neuroscience Institute - Beaufort /ID# 256385

    Beaufort, South Carolina, 29902-6216

  • Retina Consultants of Texas - Bellaire /ID# 256377

    Bellaire, Texas, 77401

  • Pacific Northwest Retina /ID# 258999

    Bellevue, Washington, 98004

  • Retina Vitreous Assoc Med Grp /ID# 256246

    Beverly Hills, California, 90211

  • Envision Ocular, LLC /ID# 256367

    Bloomfield, New Jersey, 07003

  • MA Eye & Ear Infirmary /ID# 262430

    Boston, Massachusetts, 02114

  • Ophthalmic Consultants of Boston /ID# 256233

    Boston, Massachusetts, 02114

  • Star Retina - Burleson /ID# 256376

    Burleson, Texas, 76028

  • Retinal Diagnostic Center /ID# 256262

    Campbell, California, 95008

  • Charleston Neurosciences Institute /ID# 256351

    Charleston, South Carolina, 29414-5896

  • Southeastern Retina Associates - Chattanooga /ID# 258992

    Chattanooga, Tennessee, 37421

  • Mid America Surgery Center /ID# 258993

    Chesterfield, Missouri, 63017

  • Northwestern Memorial Hospital - Department of Ophthalmology /ID# 256379

    Chicago, Illinois, 60611-2987

  • Cincinnati Eye Institute /ID# 256247

    Cincinnati, Ohio, 45242-5664

  • Retina Associates of Cleveland-Middleburg Heights /ID# 256280

    Cleveland, Ohio, 44130

  • Cleveland Clinic - Cleveland /ID# 256282

    Cleveland, Ohio, 44195

  • Retina Consultants of Southern Colorado /ID# 256285

    Colorado Springs, Colorado, 80909

  • University of Missouri Hospital /ID# 262474

    Columbia, Missouri, 65212

  • Ohio State University /ID# 256275

    Columbus, Ohio, 43210

  • Texas Retina Associates /ID# 256259

    Dallas, Texas, 75231

  • Rand Eye Institute /ID# 256337

    Deerfield Beach, Florida, 33064

  • Midwest Retina /ID# 276644

    Dublin, Ohio, 43016

  • Southwest Retina Research Center /ID# 256261

    Durango, Colorado, 81303

  • Duke University Medical Center /ID# 256245

    Durham, North Carolina, 27710

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

    Edina, Minnesota, 55435

  • Retina Vitreous Center, Research /ID# 256284

    Edmond, Oklahoma, 73013

  • The Retina Partners - Encino /ID# 259660

    Encino, California, 91436

  • Palmetto Retina Center-Florence /ID# 256244

    Florence, South Carolina, 29501

  • National Ophthalmic Research Institute /ID# 256344

    Fort Myers, Florida, 33912-7125

  • Texas Retina Associates - Fort Worth /ID# 256326

    Fort Worth, Texas, 76104

  • Retina Consultants of Orange County /ID# 256267

    Fullerton, California, 92835

  • Vitreoretinal Associates, P.A. /ID# 256266

    Gainesville, Florida, 32607

  • Charles Retina Institute /ID# 256237

    Germantown, Tennessee, 38138

  • Retina Associates of Michigan /ID# 256393

    Grand Blanc, Michigan, 48439

  • Mid Atlantic Retina Specialists - Hagerstown /ID# 256310

    Hagerstown, Maryland, 21740-5965

  • Graystone Eye /ID# 256424

    Hickory, North Carolina, 28602

  • Retina Partners Midwest, PC /ID# 256277

    Indianapolis, Indiana, 46290

  • Southeastern Retina Associates - Johnson City /ID# 256396

    Johnson City, Tennessee, 37604

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

    La Crosse, Wisconsin, 54601

  • Jacobs Retina Center at UCSD/ID# 256320

    La Jolla, California, 92093

  • Charleston Neurosciences Institute /ID# 256336

    Ladson, South Carolina, 29414-5896

  • Florida Retina Consultants /ID# 256321

    Lakeland, Florida, 33805

  • Colorado Retina Associates /ID# 256378

    Lakewood, Colorado, 80228

  • University Retina and Macula Associates /ID# 256288

    Lemont, Illinois, 60439

  • Retina Associates - Lenexa /ID# 258296

    Lenexa, Kansas, 66215

  • Monmouth Retina Consultants /ID# 275895

    Little Silver, New Jersey, 07739

  • Advanced Vision Research Institute /ID# 256380

    Longmont, Colorado, 80503

  • Piedmont Eye Center /ID# 256386

    Lynchburg, Virginia, 24502

  • Mississippi Retina Associates /ID# 270934

    Madison, Mississippi, 39110-2028

  • Retina Consultants, P.C. /ID# 273610

    Manchester, Connecticut, 06042-3556

  • Georgia Retina - Marietta /ID# 256264

    Marietta, Georgia, 30060

  • Rocky Mountain Retina Consultants /ID# 256369

    Murray, Utah, 84107

  • Tennessee Retina - Nashville /ID# 256388

    Nashville, Tennessee, 37203-1513

  • Vanderbilt University Medical Center /ID# 256372

    Nashville, Tennessee, 37232-0011

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

    New Albany, Indiana, 47150

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

    New York, New York, 10032

  • Wagner Kapoor Research Institute - Norfolk /ID# 256260

    Norfolk, Virginia, 23502

  • University Retina and Macula Associates /ID# 256287

    Oak Forest, Illinois, 60452

  • Illinois Retina Associates - Oak Park /ID# 256375

    Oak Park, Illinois, 60304

  • Florida Retina Institute - Orlando /ID# 256373

    Orlando, Florida, 32806-1101

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

    Oxnard, California, 93036

  • Byers Eye Institute Stanford /ID# 262853

    Palo Alto, California, 94303

  • Retina Specialty Institute /ID# 256268

    Pensacola, Florida, 32503

  • University of Pennsylvania /ID# 258995

    Philadelphia, Pennsylvania, 19104-5502

  • Mid Atlantic Retina /ID# 256232

    Philadelphia, Pennsylvania, 19107

  • Barnet Dulaney Eye Center-Phoenix /ID# 256340

    Phoenix, Arizona, 85016

  • Retinal Research Institute /ID# 256238

    Phoenix, Arizona, 85053

  • University of Pittsburgh Medical Center /ID# 258994

    Pittsburgh, Pennsylvania, 15213

  • Fort Lauderdale Eye Institute /ID# 266011

    Plantation, Florida, 33324

  • Maine Eye Center - Marginal Way Campus /ID# 256391

    Portland, Maine, 04101

  • Retina Consultants of San Diego /ID# 256258

    Poway, California, 92064-2530

  • Black Hills Regional Eye Institute /ID# 262872

    Rapid City, South Dakota, 57701

  • Sierra Eye Associates /ID# 256239

    Reno, Nevada, 89502

  • Retina Institute of Virginia /ID# 256394

    Richmond, Virginia, 23235

  • Kaiser Permanente - Riverside Medical Center /ID# 262413

    Riverside, California, 92505

  • Vistar Eye Center /ID# 271024

    Roanoke, Virginia, 24019

  • Mayo Clinic - Rochester /ID# 258295

    Rochester, Minnesota, 55905-0001

  • Retina Associates of Western New York /ID# 256374

    Rochester, New York, 14620

  • Austin Retina Associates - Round Rock /ID# 256387

    Round Rock, Texas, 78681

  • Associated Retinal Consultants /ID# 256269

    Royal Oak, Michigan, 48073

  • UC Davis Health Eye Center

    Sacramento, California, 95817

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

    Sacramento, California, 95841

  • Retina Associates of Utah /ID# 256276

    Salt Lake City, Utah, 84107

  • Retina Consultants of Texas/ID# 259661

    San Antonio, Texas, 78240-1655

  • Retina Associates of South Texas

    San Antonio, Texas, 78240

  • Retina Consultants of Texas /ID# 256382

    San Antonio, Texas, 78251

  • Orange County Retina Medical Group /ID# 256286

    Santa Ana, California, 92705

  • Retina Macula Institute of Arizona /ID# 271026

    Scottsdale, Arizona, 85255-4134

  • Retina Center NW, PLLC /ID# 256395

    Silverdale, Washington, 98383

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

    Southlake, Texas, 76092

  • Spokane Eye Clinic /ID# 256338

    Spokane, Washington, 99204

  • Springfield Clinic - First /ID# 256371

    Springfield, Illinois, 62702

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

    St Louis, Missouri, 63108

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

    St. Petersburg, Florida, 33711-1141

  • Macula Retina Vitreous Center - Torrance /ID# 270247

    Torrance, California, 90503

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

    Walnut Creek, California, 94598

  • Wolfe Eye Clinic - West Des Moines /ID# 256314

    West Des Moines, Iowa, 50266

  • Center for Retina and Macular Disease /ID# 256335

    Winter Haven, Florida, 33880

  • Vitreo Retinal Associates - Worcester /ID# 266008

    Worcester, Massachusetts, 01605

Other trials in United States

United Kingdom14 sites

  • Stoke Mandeville Hospital /ID# 277343

    Aylesbury, Buckinghamshire, HP21 8AL

  • Bradford Royal Infirmary /ID# 273164

    Bradford, BD9 6RJ

  • Bristol Eye Hospital /ID# 271619

    Bristol, BS1 2LX

  • Gloucestershire Royal Hospital /ID# 277362

    Gloucester, Gloucestershire, GL1 3NN

  • Leeds Teaching Hospital /ID# 277366

    Leeds, West Yorkshire, LS9 7TF

  • Liverpool University Hospitals NHS Foundation Trust /ID# 262305

    Liverpool, L7 8XP

  • Western Eye Hospital /ID# 271621

    London, England, NW1 5QH

  • Moorfields Eye Hospital /ID# 263038

    London, Greater London, EC1V 2PD

  • The Retina Clinic London /ID# 262304

    London, Greater London, W1G 7LB

  • Manchester University NHS Foundation Trust /ID# 262404

    Manchester, M9 2AA

  • Royal Victoria Infirmary /ID# 277368

    Newcastle upon Tyne, NE1 4LP

  • Oxford University Hospitals NHS Foundation Trust /ID# 262306

    Oxford, Oxfordshire, OX3 9DU

  • University Hospital Southampton NHS Foundation Trust /ID# 262307

    Southampton, Hampshire, SO16 6YD

  • Sunderland Eye Infirmary /ID# 271620

    Sunderland, SR2 9HP

Other trials in United Kingdom

Canada10 sites

  • Calgary Retina Consultants /ID# 258997

    Calgary, Alberta, T2H 0C8

  • Alberta Retina Consultants /ID# 265599

    Edmonton, Alberta, T5H 0X5

  • Vitreous Retina Macula Specialists of Toronto /ID# 258299

    Etobicoke, Ontario, M8X 2X3

  • Retina Surgical Associates /ID# 270958

    New Westminster, British Columbia, V3L 5H1

  • Ottawa Hospital Research Institute /ID# 258998

    Ottawa, Ontario, K1H 8L6

  • Retina Centre of Ottawa /ID# 259659

    Ottawa, Ontario, K2B 7E9

  • CHU de Quebec-Universite Laval /ID# 258996

    Québec, Quebec, G1R 2J6

  • Toronto Retina Institute /ID# 265602

    Toronto, Ontario, M3C 0G9

  • Sunnybrook Research Institute /ID# 270690

    Toronto, Ontario, M4N 3M5

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

    Vancouver, British Columbia, V5Z 3N9

Other trials in Canada

France10 sites

  • Centre Hosp Intercommunal de Creteil /ID# 262407

    Créteil, Val-de-Marne, 94000

  • CHU Dijon /ID# 262410

    Dijon, Cote-d Or, 21000

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

    Lyon, Auvergne-Rhône-Alpes, 69004

  • Clinique Juge /ID# 262417

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

  • Clinique Honoré Cave /ID# 262225

    Montauban, 82017

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

    Nantes, Pays de la Loire Region, 44000

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

    Nice, Alpes-Maritimes, 06001

  • Hopitaux Universitaires Paris Centre-Hopital Cochin /ID# 262415

    Paris, Paris, 75679

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

    Paris, 75010

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

    Toulouse, Occitanie, 31059

Other trials in France

Italy10 sites

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

    Bari, 70124

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

    Chieti, 67100

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

    Cona, Ferrara, 44124

  • IRCCS Ospedale San Raffaele /ID# 263035

    Milan, Milano, 20132

  • ASST Fatebenefratelli Sacco /ID# 263273

    Milan, Milano, 20157

  • Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 264074

    Naples, Napoli, 80138

  • IRCCS Ospedale Sacro Cuore Don Calabria /ID# 263536

    Negrar, Verona, 37024

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

    Rome, Roma, 00168

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

    Rome, Roma, 00184

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

    Udine, 33100

Other trials in Italy

Spain10 sites

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

    Barcelona, 08028

  • Instituto de Microcirugía Ocular /ID# 262642

    Barcelona, 08035

  • Hospital Santa Creu i Sant Pau /ID# 262637

    Barcelona, 08041

  • Hospital Arruzafa /ID# 262634

    Córdoba, Cordoba, 14012

  • Hospital Universitari de Bellvitge /ID# 262641

    L'Hospitalet de Llobregat, Barcelona, 08907

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

    Las Palmas de Gran Canaria, Las Palmas, 35016

  • Hospital Universitario 12 de Octubre /ID# 262636

    Madrid, 28041

  • Clinica Baviera /ID# 270146

    Madrid, 28046

  • Hospital Universitario Puerta de Hierro - Majadahonda /ID# 262635

    Majadahonda, Madrid, 28222

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

    Santiago de Compostela, A Coruna, 15706

Other trials in Spain

Japan9 sites

  • Juntendo University Hospital /ID# 258715

    Bunkyo-ku, Tokyo, 113-8431

  • Fukushima Medical University Hospital /ID# 258411

    Fukushima, Fukushima, 960-1295

  • Kagoshima University Hospital /ID# 257053

    Kagoshima, Kagoshima-ken, 890-8520

  • Kobe City Eye Hospital /ID# 256948

    Kobe, Hyōgo, 650-0047

  • Kyoto University Hospital /ID# 267351

    Kyoto, Kyoto, 606-8507

  • University of Miyazaki Hospital /ID# 262879

    Miyazaki, Miyazaki, 889-1692

  • Nagoya University Hospital /ID# 267350

    Nagoya, Aichi-ken, 466-8560

  • Hyogo Medical University Hospital /ID# 257893

    Nishinomiya-shi, Hyōgo, 663-8501

  • Shiga University of Medical Science /ID# 266862

    Ōtsu, Shiga, 520-2192

Other trials in Japan

Germany7 sites

  • Universitaetsklinikum Bonn /ID# 262498

    Bonn, North Rhine-Westphalia, 53127

  • Universitaetsklinikum Freiburg /ID# 262495

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Universitaetsklinikum Hamburg-Eppendorf /ID# 262493

    Hamburg, 20246

  • Klinikum Ludwigshafen /ID# 262497

    Ludwigshafen am Rhein, Rhineland-Palatinate, 67063

  • Universitaetsklinikum Muenster /ID# 262499

    Münster, North Rhine-Westphalia, 48149

  • Knappschaftsklinikum Saar /ID# 262496

    Püttlingen, 66346

  • Universitaetsklinikum Ulm /ID# 262494

    Ulm, Baden-Wurttemberg, 89081

Other trials in Germany

Hungary3 sites

  • Budapest Retina Intezet /ID# 262647

    Budapest, 1133

  • Debreceni Egyetem-Klinikai Kozpont /ID# 262646

    Debrecen, Hajdú-Bihar, 4032

  • Ganglion Orvosi Központ /ID# 264550

    Pécs, 7621

Other trials in Hungary

Puerto Rico1 site

  • Emanuelli Research & Development Center LLC /ID# 256231

    Arecibo, 00612

Other trials in Puerto Rico

About this study

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

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.

Read the detailed description

This randomized, partially masked, controlled, Phase 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 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 ABBV-RGX-314 relative to aflibercept. Approximately 714 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), while 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.

Being tested
ABBV-RGX-314 Dose 1, ABBV-RGX-314 Dose 2, Aflibercept (EYLEA®)
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
Medical subject headings
Macular Degeneration, Wet Macular Degeneration, Choroidal Neovascularization, Retinal Degeneration, Retinal Diseases, Eye Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABBV-RGX-314 Dose 1Genetic

    Also called RGX-314, surabgene lomparvovec

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

  • ABBV-RGX-314 Dose 2Genetic

    Also called RGX-314, surabgene lomparvovec

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

  • Aflibercept (EYLEA®)Biological

    Also called Eylea (anti-VEGF agent)

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

Study groups in NCT05407636
Study groupRoleWhat they receive
ABBV-RGX-314 Dose 1ExperimentalABBV-RGX-314 Dose 1 administered via subretinal delivery one time.
Receives: Genetic: ABBV-RGX-314 Dose 1
ABBV-RGX-314 Dose 2ExperimentalABBV-RGX-314 Dose 2 administered via subretinal delivery one time.
Receives: Genetic: ABBV-RGX-314 Dose 2
Control ArmActive comparatorAflibercept administered via intravitreal injection approximately every 8 weeks
Receives: Biological: Aflibercept (EYLEA®)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: At Week 54

  2. Bilateral Treatment Substudy: Incidence of ocular AEs and any SAEs

    AEs and SAEs through Week 50

    Measured: Week 50

Secondary outcomes (35)

  1. Incidences of ocular and overall AEs

    To evaluate the safety and tolerability of ABBV-RGX-314 through Week 54

    Measured: Through Week 54

  2. Proportion of participants with improved BCVA

    To evaluate the effect of ABBV-RGX-314 relative to aflibercept on BCVA

    Measured: Week 54

  3. Proportion of participants with worsened BCVA

    To evaluate the effect of ABBV-RGX-314 relative to aflibercept on BCVA

    Measured: Week 54

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

    To evaluate the effect of ABBV-RGX-314 relative to aflibercept on BCVA

    Measured: Week 54

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

    To evaluate the effect of ABBV-RGX-314 relative to aflibercept on BCVA

    Measured: Week 54

  6. Mean change from Week 54 to Week 108 in BCVA (control arm participants who cross over to ABBV-RGX-314)

    To evaluate the effect of ABBV-RGX-314 relative to aflibercept on BCVA

    Measured: Week 54 to Week 108

  7. Mean change in central retinal thickness (CRT) as measured by SD-OCT

    To evaluate the effect of ABBV-RGX-314 relative to aflibercept on CRT as measured by SD-OCT

    Measured: Through Week 108

  8. Mean change in central point thickness (CPT) as measured by SD-OCT

    To evaluate the effect of ABBV-RGX-314 relative to aflibercept on CPT as measured by SD-OCT

    Measured: Through Week 108

  9. Mean number of supplemental anti-VEGF injections from Baseline through Week 54 (ABBV-RGX-314 randomized participants) and from Week 54 through Week 108 (control arm participants who cross over to ABBV-RGX-314)

    To assess the need for supplemental anti-VEGF therapy in participants treated with ABBV-RGX-314

    Measured: Through Week 108

  10. Proportion of participants with 0, 1, 2, and 3 supplemental injections through Week 54 (ABBV-RGX-314 randomized participants) and from Week 54 through Week 108 (control arm participants who cross over to ABBV-RGX-314)

    To assess the need for supplemental anti-VEGF therapy in participants treated with ABBV-RGX-314

    Measured: Through Week 108

  11. Proportion of participants with ≤ 1, ≤ 2, and ≤ 3 supplemental injections through Week 54 (ABBV-RGX-314 randomized participants) and from Week 54 through Week 108 (control arm participants who cross over to ABBV-RGX-314)

    To assess the need for supplemental anti-VEGF therapy in participants treated with ABBV-RGX-314

    Measured: Through Week 108

  12. Proportion of participants that received 1 or 2 injections through Week 54 (ABBV-RGX-314 randomized participants) and from Week 54 through Week 108 (control arm participants who cross over to ABBV-RGX-314)

    To assess the need for supplemental anti-VEGF therapy in participants treated with ABBV-RGX-314

    Measured: Through Week 108

  13. Proportion of participants with a reduction of ≥ 50% in anti-VEGF injection annualized rate through Week 54 compared with the prior year (ABBV-RGX-314 randomized participants)

    To assess the need for supplemental anti-VEGF therapy in participants treated with ABBV-RGX-314

    Measured: Through Week 54

  14. Proportion of participants with a reduction of ≥ 75% in anti-VEGF injection annualized rate through Week 54 compared with the prior year (ABBV-RGX-314 randomized participants)

    To assess the need for supplemental anti-VEGF therapy in participants treated with ABBV-RGX-314

    Measured: Through Week 54

  15. Percent reduction in anti-VEGF injection annualized rate through Week 54 compared with the prior year (ABBV-RGX-314 randomized participants)

    To assess the need for supplemental anti-VEGF therapy in participants treated with ABBV-RGX-314

    Measured: Through Week 54

  16. Supplemental anti-VEGF injection annualized rate through Week 54 (ABBV-RGX-314 randomized participants)

    To assess the need for supplemental anti-VEGF therapy in participants treated with ABBV-RGX-314

    Measured: Through Week 54

  17. Percent reduction in anti-VEGF injection annualized rate after Week 58 through Week 108 relative to the year prior to study (control arm participants who cross over to ABBV-RGX-314)

    To assess the need for supplemental anti-VEGF therapy in participants treated with ABBV-RGX-314

    Measured: Through Week 108

  18. Supplemental anti-VEGF injection annualized rate after Week 58 through Week 108 (control arm participants who cross over to ABBV-RGX-314)

    To assess the need for supplemental anti-VEGF therapy in participants treated with ABBV-RGX-314

    Measured: Through Week 108

  19. Time to first supplemental anti- VEGF injection after the Week 2 injection (ABBV-RGX-314 randomized participants)

    To assess the need for supplemental anti-VEGF therapy in participants treated with ABBV-RGX-314

    Measured: Through Week 54

  20. Time to first supplemental anti-VEGF injection after the Week 58 injection (control arm participants who cross over to ABBV-RGX-314)

    To assess the need for supplemental anti-VEGF therapy in participants treated with ABBV-RGX-314

    Measured: Through Week 108

  21. Mean change from Baseline in NEI VFQ-25 (composite score) at Week 54 and (control arm participants who cross over to ABBV-RGX-314) Week 108

    To evaluate patient-reported visual function and treatment satisfaction using PRO questionnaires

    Measured: Week 54 and Week 108

  22. Mean change from Baseline in MacTSQ (composite score) at Week 54 and (control arm participants who cross over to ABBV-RGX-314) Week 108

    To evaluate patient-reported visual function and treatment satisfaction using PRO questionnaires

    Measured: Week 54 and Week 108

  23. Aqueous humor ABBV-RGX-314 TP concentrations at Week -2, Week 14, Week 38, and Week 54 (ABBV-RGX-314 randomized participants)

    To assess aqueous humor and serum TP concentrations prior to and after ABBV-RGX-314 administration

    Measured: Through Week 54

  24. Aqueous humor ABBV-RGX-314 TP concentrations at Week 54, Week 74, Week 90, and Week 108 (control arm participants who cross over to ABBV-RGX-314)

    To assess aqueous humor and serum TP concentrations prior to and after ABBV-RGX-314 administration

    Measured: Through Week 108

  25. Serum ABBV-RGX-314 TP concentrations (at select sites)

    To assess aqueous humor and serum TP concentrations prior to and after ABBV-RGX-314 administration

    Measured: Through Week 54

  26. Immunogenicity measurements (ABBV-RGX-314 randomized participants)

    Immunogenicity measurements (serum antibodies to AAV8 and serum antibodies to ABBVRGX- 314 TP)

    Measured: Week -2, Week 14, Week 38, and Week 54

  27. Immunogenicity measurements (control arm participants who cross over to ABBV-RGX-314)

    Immunogenicity measurements (serum antibodies to AAV8 and serum antibodies to ABBV-RGX- 314 TP)

    Measured: Week 54, Week 74, Week 90, and Week 108

  28. Bilateral Treatment Substudy: Incidence of nonocular AEs and any AESIs

    To evaluate the safety and tolerability of bilateral treatment of ABBV-RGX-314 gene therapy

    Measured: Week 50

  29. Bilateral Treatment Substudy: Mean change from Baseline in BCVA at assessed time points

    BCVA measured by ETDRS

    Measured: Week 50

  30. Bilateral Treatment Substudy: Mean change from Baseline in CRT at assessed time points

    Mean change in CRT as measured by SD-OCT

    Measured: Through Week 50

  31. Bilateral Treatment Substudy: Supplemental anti-VEGF injection annualized rate

    Supplemental anti-VEGF injection annualized rate

    Measured: Through Week 50

  32. Bilateral Treatment Substudy: Mean number of supplemental anti-VEGF injections

    Mean supplemental anti-VEGF injections

    Measured: Through Week 50

  33. Bilateral Treatment Substudy: Proportion of participants with 0, ≤ 1, ≤ 2, and ≤ 3 supplemental anti-VEGF injections

    Proportion of participants with 0, ≤ 1, ≤ 2, and ≤ 3 supplemental anti-VEGF injections

    Measured: Through Week 50

  34. Bilateral Treatment Substudy: Aqueous humor and serum ABBV-RGX-314 TP concentrations

    Aqueous humor and serum ABBV-RGX-314 TP concentrations

    Measured: Week 26, Week 34, Week 50

  35. Bilateral Treatment Substudy: Immunogenicity measurements (serum anti-ABBV-RGX-314 TP antibodies, serum anti-AAV8 antibodies) and enzyme-linked immunospot at assessed time points

    Immunogenicity measurements

    Measured: Week 50

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2022
  2. Study start13 Jan 2022
  3. Primary completionOct 2026 (estimated)
  4. Study completionNov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
2 ABBV-RGX-314 treatment arms, 1 control arm (aflibercept)
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
735 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05407636
Sponsor's protocol ID
RGX-314-3101
Other IDs
M23-409
Acronym
ASCENT
Status last verified
Jul 2026
First submitted
28 Jan 2022
Last updated
3 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ABBV-RGX-314 Dose 1, ABBV-RGX-314 Dose 2 and Aflibercept (EYLEA®) in people with AMD and nAMD, run by AbbVie at 181 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 181 sites in United States, United Kingdom, Canada, France, Italy and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean change from baseline in Best Corrected Visual Acuity (BCVA) (time frame: At Week 54). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05407636.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in