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)

Official title

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)

Overview

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.

Interventions

• Drug Surabgene Lomparvovec (ABBV-RGX-314)
  subretinal injection
• Drug Ranibizumab Control
  intravitreal injection

Primary outcome measures

• Annualized intravitreal anti-VEGF injection rate [Time frame: Up to Week 54]
• Number of Participants Experiencing Adverse Events [Time frame: Up to 5 years]

Secondary outcome measures (2)

• Change from Baseline in best corrected visual acuity (BCVA) [Time frame: Up to 3 Years]
• Annualized intravitreal anti-VEGF injection rate [Time frame: Up to 3 Years]

Eligibility criteria

Inclusion criteria

• 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)

Exclusion criteria

• CNV or macular edema in the study eye that is secondary to any causes other than AMD
• Study eye with nAMD diagnosed > 4 years from Screening Visit 1
• 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.
• 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
• Retinal pigment epithelial tear involving the central subfield (central 1 mm) in the study eye as determined by the central reading center.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

United States · 52 centers

• Barnet Dulaney Perkins Eye Centers /ID# 279265 — Mesa
• American Vision Partners /ID# 264615 — Sun City
• Retinal Diagnostic Center /ID# 263054 — Campbell
• The Retina Partners /ID# 263265 — Encino
• Retina Associates of Southern California /ID# 263056 — Huntington Beach
• Northern California Retina Vitreous Associates - Mountain View /ID# 263990 — Mountain View
• Eye Research Foundation /ID# 277345 — Newport Beach
• Retina Consultants of San Diego /ID# 264026 — Poway
• … and 44 more centers

Germany · 11 centers

• Universitaetsklinikum Freiburg /ID# 275449 — Freiburg im Breisgau
• Universitaetsklinikum Tuebingen /ID# 264283 — Tübingen
• … and 9 more centers

Spain · 11 centers

Center list to be confirmed — check the primary protocol.

France · 10 centers

• Centre Hospitalier Universitaire de Nice - Hopital Pasteur /ID# 265073 — Nice
• Hopital Edouard Herriot /ID# 265072 — Lyon
• Retine Gallien /ID# 265119 — Bordeaux
• Chu Bordeaux - Hopital Pellegrin /ID# 265123 — Bordeaux
• Centre Hospitalier Universitaire de Nantes - L' Hopital l'hotel-Dieu /ID# 265077 — Nantes
• Centre Hospitalier Intercommunal de Creteil /ID# 265080 — Créteil
• Centre Monticelli Paradis d'Ophtalmologie /ID# 265120 — Marseille
• Clinique Jules Verne /ID# 265076 — Nantes
• … and 2 more centers

Israel · 8 centers

Center list to be confirmed — check the primary protocol.

United Kingdom · 6 centers

Center list to be confirmed — check the primary protocol.

Italy · 5 centers

Center list to be confirmed — check the primary protocol.

Austria · 4 centers

• Landesklinikum Mistelbach /ID# 275764 — Mistelbach
• Medizinische Universitaet Graz /ID# 264511 — Graz
• Medizinische Universitaet Innsbruck /ID# 264502 — Innsbruck
• Kepler Universitaetsklinikum GmbH /ID# 264493 — Linz

Bulgaria · 4 centers

• Specialized Eye Hospital for Active Treatment - Burgas OOD /ID# 275729 — Burgas
• OCIPSMAED St. Luka /ID# 275727 — Plovdiv
• Specialized Hospital for Active Treatment of Eye Diseases Zora /ID# 275730 — Sofia
• Medical Center -Vereya /ID# 275728 — Stara Zagora

Greece · 4 centers

Center list to be confirmed — check the primary protocol.

Croatia · 3 centers

• Klinicki Bolnicki Centar Zagreb /ID# 276047 — Grad Zagreb
• Klinicka Bolnica Sveti Duh /ID# 275871 — Zagreb
• Specijalna bolnica Svjetlost /ID# 276051 — Zagreb

Hungary · 3 centers

Center list to be confirmed — check the primary protocol.

Portugal · 3 centers

Center list to be confirmed — check the primary protocol.

Belgium · 2 centers

• UZ Gent /ID# 261300 — Ghent
• Universitair Ziekenhuis Leuven /ID# 261302 — Leuven

Czechia · 2 centers

• Ustredni vojenska nemocnice - Vojenska fakultni nemocnice Praha /ID# 264663 — Prague
• Fakultni nemocnice Kralovske Vinohrady /ID# 264660 — Prague

Canada · 1 center

• Retina Centre of Ottawa /ID# 263803 — Ottawa

Puerto Rico · 1 center

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07007065 · M24-528 · 2024-512298-28-00

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗