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
| Arm | Description | Assigned 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. |
|
|
Experimental Surabgene Lomparvovec (ABBV-RGX-314) Dose 2 |
Participants will receive Surabgene Lomparvovec (ABBV-RGX-314) Dose 2 administered via subretinal delivery one time. |
|
|
Experimental Ranibizumab Control Group |
Ranibizumab administered via intravitreal injection as needed PRN |
|
Recruiting Locations
Mesa, Arizona 85206
Sun City, Arizona 85351
Campbell, California 95008
Encino, California 91436
Huntington Beach, California 92647
Poway, California 92064-2530
Sacramento, California 95841
Santa Ana, California 92705
Colorado Springs, Colorado 80909
Lakewood, Colorado 80228
Longmont, Colorado 80503
Deerfield Beach, Florida 33064-1346
Fort Myers, Florida 33917
Lake Mary, Florida 32746
Winter Haven, Florida 33880
Augusta, Georgia 30909
Springfield, Illinois 62703-2403
Carmel, Indiana 46290
West Des Moines, Iowa 50266
Baltimore, Maryland 21209
Towson, Maryland 21204
Royal Oak, Michigan 48073
Edina, Minnesota 55435
Rochester, Minnesota 55905
St Louis, Missouri 63128
Dublin, Ohio 43016
Erie, Pennsylvania 16507
Bluffton, South Carolina 29910
Charleston, South Carolina 29414
Ladson, South Carolina 29456
Mt. Pleasant, South Carolina 29464
Austin, Texas 78705
Austin, Texas 78750-2298
Burleson, Texas 76028
Houston, Texas 77056-3030
San Antonio, Texas 78251
Murray, Utah 84107
Arecibo, Puerto Rico 00612
More Details
- Status
- Recruiting
- Sponsor
- AbbVie