Sign in

NCT07007065RecruitingPhase 3

Study to Assess the Injection Burden, Adverse Events, Change in Disease Activity, and Long-Term Preservation of Visual Acuity of Surabgene Lomparvovec in Adult Participants With Neovascular Age-Related Macular Degeneration (nAMD)

A Randomized, Controlled, Partially Masked, Phase 3b Study to Assess the Injection Burden, Efficacy, Safety, and Long-Term Preservation of Visual Acuity of Surabgene Lomparvovec (ABBV-RGX-314) in a Real-World Context in Subjects With Neovascular Age-Related Macular Degeneration (nAMD)

Source: ClinicalTrials.gov · Last updated 29 Oct 2026

Brief summary (registry, in English)

Neovascular age-related macular degeneration (nAMD), also known as "wet" AMD, is the abnormal growth of new blood vessels in the light-sensitive tissue at the back of the eye called the retina. The purpose of this study is to assess how safe and effective Surabgene Lomparvovec is in treating participants with Neovascular age-related macular degeneration (nAMD). Surabgene Lomparvovec (ABBV-RGX-314) is an investigational gene therapy being developed for the treatment of neovascular age-related macular degeneration (nAMD). Participants will be placed into 1 of 3 groups, called treatment arms. Each group receives different treatment. Adult participants aged 50 and older years with a diagnosis of previously treated nAMD will be enrolled. Around 561 participants will be enrolled in the study at approximately 150 sites worldwide. Participants in groups 1 and 2 will receive a single subretinal dose of ABBV-RGX-314. Participants in group 3 will receive Ranibizumab as needed throughout the study. Ranibizumab will be given as an intravitreal injection (injection into the jelly-like tissue that fills the eyeball injection), and ABBV-RGX-314 will be given as a subretinal (between the retina and the back of the eye) injection. The Assessment Period begins after randomization (1:1:1) to one of the ABBV-RGX-314 treatment groups or control at Week -2 and lasts up to 5 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular monthly visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
561 (estimated)
First submitted
28 May 2025
Start date
5 Nov 2025
Primary completion date
31 Mar 2033
Lead sponsor
AbbVie
NCT number
NCT07007065
EU CT number
2024-512298-28-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 561
  • From 5 Nov 2025 to the primary completion date, 31 Mar 2033
  • 145 sites in 18 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Any subretinal hemorrhage in the study eye \> 50% of the total lesion area or within the parafovea (3 mm center of the macula), as determined by the central reading center

Age

  • Study eye with nAMD diagnosed \> 4 years from Screening Visit 1

Other

  • CNV or macular edema in the study eye that is secondary to any causes other than AMD
  • Any retinal pigment epithelial detachment \> 400 μm or any pigment epithelial detachment \> 350 μm within the central subfield (central 1 mm) in the study eye at Screening Visit 1 (Week -6), as assessed by the central reading center.
  • Retinal pigment epithelial tear involving the central subfield (central 1 mm) in the study eye as determined by the central reading center.

Who the study is looking for

  • Pseudophakic (at least 12 weeks post cataract surgery at Screening Visit 1 \[Week -6\]) in the study eye.
  • Must have a diagnosis of choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) in the study eye
    • --CNV lesion characteristics as assessed by the central reading center: lesion size needs to be less than 10-disc areas (typical disc area = 2.54 mm\^2)
  • Must have received at least 2 intravitreal anti-vascular endothelial growth factor (VEGF) injections in the past 6 months in the study eye prior to Screening Visit 1 (Week -6) and have been responsive (determined by investigator)

Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (145)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Medical University of Graz
Coordinator of this site? Confirm its status
GrazAustriaRecruiting
Medizinische Universitaet Innsbruck
Coordinator of this site? Confirm its status
InnsbruckAustriaRecruiting
Johannes Kepler University Linz
Coordinator of this site? Confirm its status
LinzAustriaRecruiting
NOE Landesgesundheitsagentur
Coordinator of this site? Confirm its status
MistelbachAustriaRecruiting
Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH
Coordinator of this site? Confirm its status
SalzburgAustriaRecruiting
Universitair Ziekenhuis Gent
Coordinator of this site? Confirm its status
GentBelgiumRecruiting
UZ Leuven
Coordinator of this site? Confirm its status
LeuvenBelgiumRecruiting
Specialized Eye Hospital For Active Treatment Burgas OOD
Coordinator of this site? Confirm its status
BurgasBulgariaRecruiting
Assoc. Prof. Dr. Desislava Koleva Outpatient clinic for individual practice for specialized medical assistance in eye diseases "St. Luka" EOOD
Coordinator of this site? Confirm its status
PlovdivBulgariaRecruiting
Specialized Hospital For Active Treatment Of Eye Diseases Zora OOD
Coordinator of this site? Confirm its status
SofiaBulgariaRecruiting
Medical Center Vereya EOOD
Coordinator of this site? Confirm its status
Stara ZagoraBulgariaRecruiting
Retina Centre of Ottawa /ID# 263803
Coordinator of this site? Confirm its status
OttawaCanadaRecruiting
Fakultni nemocnice Ostrava
Coordinator of this site? Confirm its status
OstravaCzechiaRecruiting
Vseobecna fakultni nemocnice v Praze
Coordinator of this site? Confirm its status
PragueCzechiaRecruiting
Fakultni nemocnice Kralovske Vinohrady
Coordinator of this site? Confirm its status
PragueCzechiaRecruiting
Ustredni Vojenska Nemocnice Vojenska Fakultni Nemocnice Praha
Coordinator of this site? Confirm its status
Prague 6CzechiaRecruiting
Charite Universitaetsmedizin Berlin KöR
Coordinator of this site? Confirm its status
BerlinGermanyRecruiting
Universitaetsklinikum Bonn AöR
Coordinator of this site? Confirm its status
BonnGermanyRecruiting
Medical Center- University of Freiburg
Coordinator of this site? Confirm its status
Freiburg im BreisgauGermanyRecruiting
Universitaetsmedizin Goettingen
Coordinator of this site? Confirm its status
GoettingenGermanyRecruiting
University Medical Center Hamburg-Eppendorf
Coordinator of this site? Confirm its status
HamburgGermanyRecruiting
Medizinische Hochschule Hannover
Coordinator of this site? Confirm its status
HanoverGermanyRecruiting
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
Coordinator of this site? Confirm its status
Ludwigshafen Am RheinGermanyRecruiting
Universitaetsklinikum Schleswig-Holstein AöR
Coordinator of this site? Confirm its status
LuebeckGermanyRecruiting
Universitaet Muenster
Coordinator of this site? Confirm its status
MuensterGermanyRecruiting
LMU Klinikum Muenchen AöR
Coordinator of this site? Confirm its status
MunichGermanyRecruiting
Universitaetsklinikum Tuebingen AöR
Coordinator of this site? Confirm its status
TuebingenGermanyRecruiting
Universitaetsklinikum Ulm AoR
Coordinator of this site? Confirm its status
UlmGermanyRecruiting
Hospital Universitari Vall d'Hebron
Coordinator of this site? Confirm its status
BarcelonaSpainRecruiting
Instituto Clinic De Oftalmologia
Coordinator of this site? Confirm its status
BarcelonaSpainRecruiting
Centro De Oftalmologia Barraquer S.A.
Coordinator of this site? Confirm its status
BarcelonaSpainRecruiting
Metavision Arruzafa S.L.
Coordinator of this site? Confirm its status
CordobaSpainRecruiting
Hospital Universitario Donostia
Coordinator of this site? Confirm its status
DonostiaSpainRecruiting
Hospital Universitario 12 de Octubre
Coordinator of this site? Confirm its status
MadridSpainRecruiting
Hospital Universitario Puerta de Hierro de Majadahonda
Coordinator of this site? Confirm its status
MajadahondaSpainRecruiting
Instituto Oftalmologico Fernandez-Vega S.L.
Coordinator of this site? Confirm its status
OviedoSpainRecruiting
Hospital Universitario Virgen De La Macarena
Coordinator of this site? Confirm its status
SevillaSpainRecruiting
Hospital Universitario Y Politecnico La Fe
Coordinator of this site? Confirm its status
ValenciaSpainRecruiting
Hospital Clinico Universitario Lozano Blesa
Coordinator of this site? Confirm its status
ZaragozaSpainRecruiting
Centre hospitalier Universitaire de Bordeaux
Coordinator of this site? Confirm its status
BordeauxFranceRecruiting
Selarl Retine Tourny
Coordinator of this site? Confirm its status
BordeauxFranceRecruiting
Centre Hospitalier Intercommunal Créteil
Coordinator of this site? Confirm its status
CréteilFranceRecruiting
Pole Vision Val d'Ouest
Coordinator of this site? Confirm its status
ÉcullyFranceRecruiting
Hospital Edouard Herriot
Coordinator of this site? Confirm its status
LyonFranceRecruiting
Centre Monticelli Paradis d'Ophtalmologie
Coordinator of this site? Confirm its status
MarseilleFranceRecruiting
Clinique Juge
Coordinator of this site? Confirm its status
MarseilleFranceRecruiting
Centre Hospitalier Universitaire de Nantes
Coordinator of this site? Confirm its status
NantesFranceRecruiting
Institut Ophtalmologique De l Ouest Jules Verne
Coordinator of this site? Confirm its status
NantesFranceRecruiting
Centre Hospitalier Universitaire de Nice
Coordinator of this site? Confirm its status
NiceFranceRecruiting
Fondation A. de Rothschild
Coordinator of this site? Confirm its status
ParisFranceRecruiting
Centre Hospitalier National d'Ophtalmologie des Quize-Vingts
Coordinator of this site? Confirm its status
ParisFranceRecruiting
Bristol Eye Hospital /ID# 266155
Coordinator of this site? Confirm its status
BristolUnited KingdomRecruiting
Gloucestershire Royal Hospital /ID# 276072
Coordinator of this site? Confirm its status
GloucesterUnited KingdomRecruiting
Royal Liverpool University Hospital /ID# 265854
Coordinator of this site? Confirm its status
LiverpoolUnited KingdomRecruiting
Moorfields Eye Hospital /ID# 267227
Coordinator of this site? Confirm its status
LondonUnited KingdomRecruiting
The Retina Clinic London /ID# 266156
Coordinator of this site? Confirm its status
LondonUnited KingdomRecruiting
The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 267024
Coordinator of this site? Confirm its status
Newcastle upon TyneUnited KingdomRecruiting
Sunderland Royal Hospital /ID# 266664
Coordinator of this site? Confirm its status
SunderlandUnited KingdomRecruiting
General Hospital of Athens "G. Gennimatas"
Coordinator of this site? Confirm its status
AthensGreeceRecruiting
University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA"
Coordinator of this site? Confirm its status
ChaïdáriGreeceRecruiting
University General Hospital of Heraklion
Coordinator of this site? Confirm its status
HeraklionGreeceRecruiting
General University Hospital of Larissa
Coordinator of this site? Confirm its status
LarissaGreeceRecruiting
Specijalna bolnica Svjetlost
Coordinator of this site? Confirm its status
ZagrebCroatiaRecruiting
University Hospital Sveti Duh
Coordinator of this site? Confirm its status
ZagrebCroatiaRecruiting
University Hospital Centre Zagreb
Coordinator of this site? Confirm its status
ZagrebCroatiaRecruiting
Semmelweis University
Coordinator of this site? Confirm its status
Budapest VIIIHungaryRecruiting
Budapest Retina Associates Kft.
Coordinator of this site? Confirm its status
Budapest XIIIHungaryRecruiting
University of Debrecen
Coordinator of this site? Confirm its status
DebrecenHungaryRecruiting
Nozologen Kft.
Coordinator of this site? Confirm its status
PécsHungaryRecruiting
The Lady Davis Carmel Medical Center /ID# 265618
Coordinator of this site? Confirm its status
HaifaIsraelRecruiting
Edith Wolfson Medical Center /ID# 266304
Coordinator of this site? Confirm its status
HolonIsraelRecruiting
Hadassah Medical Center-Hebrew University /ID# 264300
Coordinator of this site? Confirm its status
JerusalemIsraelRecruiting
Rabin Medical Center /ID# 266449
Coordinator of this site? Confirm its status
Petah TikvaIsraelRecruiting
The Chaim Sheba Medical Center /ID# 264700
Coordinator of this site? Confirm its status
Ramat GanIsraelRecruiting
Kaplan Medical Center /ID# 264399
Coordinator of this site? Confirm its status
RehovotIsraelRecruiting
Tel Aviv Sourasky Medical Center /ID# 266246
Coordinator of this site? Confirm its status
Tel AvivIsraelRecruiting
Yitzhak Shamir Medical Center /ID# 275679
Coordinator of this site? Confirm its status
TsrifinIsraelRecruiting
Azienda Ospedaliero-Universitaria delle Marche
Coordinator of this site? Confirm its status
AnconaItalyRecruiting
University Hospital Of Ferrara
Coordinator of this site? Confirm its status
FerraraItalyRecruiting
Azienda Ospedaliero-Universitaria Careggi
Coordinator of this site? Confirm its status
FlorenceItalyRecruiting
Azienda USL IRCCS di Reggio Emilia
Coordinator of this site? Confirm its status
Reggio EmiliaItalyRecruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Coordinator of this site? Confirm its status
RomeItalyRecruiting
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Coordinator of this site? Confirm its status
TurinItalyRecruiting
Emanuelli Research & Development Center /ID# 264350
Coordinator of this site? Confirm its status
AreciboPuerto RicoRecruiting
Unidade Local de Saúde de Coimbra, E.P.E.
Coordinator of this site? Confirm its status
CoimbraPortugalRecruiting
Unidade Local De Saude De Sao Jose E.P.E.
Coordinator of this site? Confirm its status
LisbonPortugalRecruiting
Unidade Local De Saude De Santo Antonio E.P.E.
Coordinator of this site? Confirm its status
PortoPortugalRecruiting
University Hospital Bratislava
Coordinator of this site? Confirm its status
BratislavaSlovakiaNot yet recruiting
Fakultna nemocnica Trencin
Coordinator of this site? Confirm its status
TrenčínSlovakiaNot yet recruiting
Fakultna nemocnica s poliklinikou Zilina
Coordinator of this site? Confirm its status
ŽilinaSlovakiaNot yet recruiting
Retina Research Institute of Texas /ID# 263233
Coordinator of this site? Confirm its status
AbileneUnited StatesRecruiting
Southeast Retina Center /ID# 263264
Coordinator of this site? Confirm its status
AugustaUnited StatesRecruiting
Austin Retina Associates - Austin /ID# 266770
Coordinator of this site? Confirm its status
AustinUnited StatesRecruiting
Austin Clinical Research, LLC /ID# 263229
Coordinator of this site? Confirm its status
AustinUnited StatesRecruiting
The Retina Care Center /ID# 263263
Coordinator of this site? Confirm its status
BaltimoreUnited StatesRecruiting
Charleston Neuroscience Institute - Bluffton /ID# 264037
Coordinator of this site? Confirm its status
BlufftonUnited StatesRecruiting
Star Retina /ID# 266386
Coordinator of this site? Confirm its status
BurlesonUnited StatesRecruiting
Retinal Diagnostic Center /ID# 263054
Coordinator of this site? Confirm its status
CampbellUnited StatesRecruiting
Retina Partners Midwest, P.C. /ID# 264031
Coordinator of this site? Confirm its status
CarmelUnited StatesRecruiting
Charleston Neuroscience Institute - Charleston /ID# 276425
Coordinator of this site? Confirm its status
CharlestonUnited StatesRecruiting
Cleveland Clinic - Cleveland /ID# 264210
Coordinator of this site? Confirm its status
ClevelandUnited StatesRecruiting
Retina Consultants of Southern Colorado /ID# 263284
Coordinator of this site? Confirm its status
Colorado SpringsUnited StatesRecruiting
Ohio State Havener Eye Institute - Columbus /ID# 263987
Coordinator of this site? Confirm its status
ColumbusUnited StatesRecruiting
Advanced Research, LLC /ID# 276526
Coordinator of this site? Confirm its status
Deerfield BeachUnited StatesRecruiting
Segal Drug Trials, Inc /ID# 276966
Coordinator of this site? Confirm its status
Delray BeachUnited StatesRecruiting
Midwest Retina /ID# 263231
Coordinator of this site? Confirm its status
DublinUnited StatesRecruiting
Retina Consultants of Minnesota (RCM) - Edina Retina Clinic /ID# 279427
Coordinator of this site? Confirm its status
EdinaUnited StatesRecruiting
The Retina Partners /ID# 263265
Coordinator of this site? Confirm its status
EncinoUnited StatesRecruiting
Erie Retina Research /ID# 263287
Coordinator of this site? Confirm its status
ErieUnited StatesRecruiting
Retina Vitreous Consultants LLP business DBA as Retina Group of Florida /ID# 264631
Coordinator of this site? Confirm its status
Fort MyersUnited StatesRecruiting
Retina Consultants of Texas /ID# 263274
Coordinator of this site? Confirm its status
HoustonUnited StatesRecruiting
Retina Associates of Southern California /ID# 263056
Coordinator of this site? Confirm its status
Huntington BeachUnited StatesRecruiting
Retina Consultants of South Carolina - Ladson /ID# 277596
Coordinator of this site? Confirm its status
LadsonUnited StatesRecruiting
Shiley Eye Institute At Uc San Diego Health /ID# 276682
Coordinator of this site? Confirm its status
La JollaUnited StatesRecruiting
Colorado Retina Associates /ID# 263247
Coordinator of this site? Confirm its status
LakewoodUnited StatesRecruiting
Retina Associates - Lenexa /ID# 264607
Coordinator of this site? Confirm its status
LenexaUnited StatesRecruiting
Monmouth Retina Consultants /ID# 279252
Coordinator of this site? Confirm its status
Little SilverUnited StatesRecruiting
Advanced Vision Surgery Center /ID# 264208
Coordinator of this site? Confirm its status
LongmontUnited StatesRecruiting
Barnet Dulaney Perkins Eye Center - Mesa /ID# 279265
Coordinator of this site? Confirm its status
MesaUnited StatesRecruiting
Northern California Retina Vitreous Associates - Mountain View /ID# 263990
Coordinator of this site? Confirm its status
Mountain ViewUnited StatesRecruiting
Retina Consultants of America /ID# 264038
Coordinator of this site? Confirm its status
Mt. PleasantUnited StatesRecruiting
Rocky Mountain Retina Consultants /ID# 263266
Coordinator of this site? Confirm its status
MurrayUnited StatesRecruiting
Eye Research Foundation /ID# 277345
Coordinator of this site? Confirm its status
Newport BeachUnited StatesRecruiting
Vision Medical Research /ID# 277102
Coordinator of this site? Confirm its status
Oak LawnUnited StatesRecruiting
Florida Retina Institute - Orlando /ID# 263288
Coordinator of this site? Confirm its status
OrlandoUnited StatesRecruiting
Mid Atlantic Retina - Philadelphia /ID# 263291
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesRecruiting
Maine Eye Center - Marginal Way Campus /ID# 263251
Coordinator of this site? Confirm its status
PortlandUnited StatesRecruiting
Retina Consultants of San Diego /ID# 264026
Coordinator of this site? Confirm its status
PowayUnited StatesRecruiting
Black Hills Regional Eye Institute /ID# 279258
Coordinator of this site? Confirm its status
Rapid CityUnited StatesRecruiting
Retina Consultants Of Southern California - Redlands /ID# 276496
Coordinator of this site? Confirm its status
RedlandsUnited StatesRecruiting
Sierra Eye Associates /ID# 263240
Coordinator of this site? Confirm its status
RenoUnited StatesRecruiting
Kaiser Permanente - Riverside Medical Center /ID# 263253
Coordinator of this site? Confirm its status
RiversideUnited StatesRecruiting
Mayo Clinic - Minnesota /ID# 263977
Coordinator of this site? Confirm its status
RochesterUnited StatesRecruiting
Austin Retina Associates - Round Rock /ID# 266776
Coordinator of this site? Confirm its status
Round RockUnited StatesRecruiting
Associated Retinal Consultants /ID# 263289
Coordinator of this site? Confirm its status
Royal OakUnited StatesRecruiting
Retinal Consultants - Sacramento - Greenback Lane /ID# 263983
Coordinator of this site? Confirm its status
SacramentoUnited StatesRecruiting
Retina Consultants of Texas - Westover /ID# 264209
Coordinator of this site? Confirm its status
San AntonioUnited StatesRecruiting
UCSF, Wayne and Gladys Valley Center for Vision /ID# 263058
Coordinator of this site? Confirm its status
San FranciscoUnited StatesRecruiting
Orange County Retina Medical Group /ID# 266612
Coordinator of this site? Confirm its status
Santa AnaUnited StatesRecruiting
Springfield Clinic Main Campus /ID# 265202
Coordinator of this site? Confirm its status
SpringfieldUnited StatesRecruiting
Retina Institute - St. Louis /ID# 263985
Coordinator of this site? Confirm its status
St LouisUnited StatesRecruiting
American Vision Partners /ID# 264615
Coordinator of this site? Confirm its status
Sun CityUnited StatesRecruiting
Retina Specialist /ID# 264633
Coordinator of this site? Confirm its status
TowsonUnited StatesRecruiting
Wolfe Eye Clinic - West Des Moines /ID# 263270
Coordinator of this site? Confirm its status
West Des MoinesUnited StatesRecruiting
Center for Retina and Macular Disease /ID# 264201
Coordinator of this site? Confirm its status
Winter HavenUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.