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)

Purpose

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.

Condition

  • Neovascular Age-related Macular Degeneration

Eligibility

Eligible Ages
Over 50 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Surabgene Lomparvovec (ABBV-RGX-314) Dose 1
Participants will receive Surabgene Lomparvovec (ABBV-RGX-314) Dose 1 administered via subretinal delivery one time.
  • Drug: Surabgene Lomparvovec (ABBV-RGX-314)
    subretinal injection
    Other names:
    • Surabgene Lomparvovec
Experimental
Surabgene Lomparvovec (ABBV-RGX-314) Dose 2
Participants will receive Surabgene Lomparvovec (ABBV-RGX-314) Dose 2 administered via subretinal delivery one time.
  • Drug: Surabgene Lomparvovec (ABBV-RGX-314)
    subretinal injection
    Other names:
    • Surabgene Lomparvovec
Experimental
Ranibizumab Control Group
Ranibizumab administered via intravitreal injection as needed PRN
  • Drug: Ranibizumab Control
    intravitreal injection

Recruiting Locations

American Vision Partners /ID# 264615
Sun City 5316201, Arizona 5551752 85351

Retinal Diagnostic Center /ID# 263054
Campbell 5333689, California 5332921 95008

The Retina Partners /ID# 263265
Encino 5346649, California 5332921 91436

Colorado Retina Associates /ID# 263247
Lakewood 5427946, Colorado 5417618 80228

Advanced Research, LLC /ID# 276526
Deerfield Beach 4153071, Florida 4155751 33064-1346

Florida Retina Institute - Lake Mary /ID# 263288
Lake Mary 4161373, Florida 4155751 32746

Southeast Retina Center /ID# 263264
Augusta 4180531, Georgia 4197000 30909

Charleston Neuroscience Institute /ID# 264037
Bluffton 4571722, South Carolina 4597040 29910

Charleston Neuroscience Institute /ID# 276425
Charleston 4574324, South Carolina 4597040 29414

Retina Consultants of South Carolina - Ladson /ID# 277596
Ladson 4584277, South Carolina 4597040 29456

Retina Consultants of America /ID# 264038
Mt. Pleasant 4588165, South Carolina 4597040 29464

Star Retina - Burleson /ID# 266386
Burleson 4677551, Texas 4736286 76028

More Details

Status
Recruiting
Sponsor
AbbVie

Study Contact

ABBVIE CALL CENTER
844-663-3742
abbvieclinicaltrials@abbvie.com