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) (NCT07007065)
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)
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Barnet Dulaney Perkins Eye Centers /ID# 279265 โ Mesa, Arizona
Age range: 50 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (131 Sites)
Showing the first 25 of 131 sites.
- Barnet Dulaney Perkins Eye Centers /ID# 279265 โ Mesa, Arizona
- American Vision Partners /ID# 264615 โ Sun City, Arizona
- Retinal Diagnostic Center /ID# 263054 โ Campbell, California
- The Retina Partners /ID# 263265 โ Encino, California
- Retina Associates of Southern California /ID# 263056 โ Huntington Beach, California
- Northern California Retina Vitreous Associates - Mountain View /ID# 263990 โ Mountain View, California
- Eye Research Foundation /ID# 277345 โ Newport Beach, California
- Retina Consultants of San Diego /ID# 264026 โ Poway, California
- Retina Consultants Of Southern California - Redlands /ID# 276496 โ Redlands, California
- Kaiser Permanente - Riverside Medical Center /ID# 263253 โ Riverside, California
- Retinal Consultants - Sacramento - Greenback Lane /ID# 263983 โ Sacramento, California
- UCSF, Wayne and Gladys Valley Center for Vision /ID# 263058 โ San Francisco, California
- Orange County Retina Medical Group /ID# 266612 โ Santa Ana, California
- Retina Consultants of Southern Colorado /ID# 263284 โ Colorado Springs, Colorado
- Colorado Retina Associates /ID# 263247 โ Lakewood, Colorado
- Advanced Vision Surgery Center /ID# 264208 โ Longmont, Colorado
- Advanced Research, LLC /ID# 276526 โ Deerfield Beach, Florida
- Segal Drug Trials, Inc /ID# 276966 โ Delray Beach, Florida
- Retina Vitreous Consultants LLP business DBA as Retina Group of Florida /ID# 264631 โ Fort Myers, Florida
- Leder Retina & Uveitis Specialist /ID# 276824 โ Jacksonville, Florida
- Florida Retina Institute - Lake Mary /ID# 263288 โ Lake Mary, Florida
- Center for Retina and Macular Disease /ID# 264201 โ Winter Haven, Florida
- Southeast Retina Center /ID# 263264 โ Augusta, Georgia
- Vision Medical Research /ID# 277102 โ Oak Lawn, Illinois
- Springfield Clinic Main Campus /ID# 265202 โ Springfield, Illinois
๐ Contact the Study Coordinator
Phone: (844) 663-3742
Email: abbvieclinicaltrials@abbvie.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Neovascular Age-related Macular Degeneration
- A Phase 3b, Single-Arm Study of Aflibercept 8 mg Dosed Every 4 Weeks in Adult Participants With Neovascular Age-Related Macular Degeneration (nAMD) or Diabetic Macular Edema (DME) โ Arcadia, California
- A Safety and Efficacy Study of One-time SAR402663 in Adults With Neovascular Age-related Macular Degeneration โ Phoenix, Arizona
- Effect of AIV007 by Periocular Administration in Subjects with Macular Edema Secondary to Neovascular Age-related Macular Degeneration (nAMD) and Diabetic Macular Edema (DME) โ Beverly Hills, California
- Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects With Neovascular Age- Related Macular Degeneration โ Gilbert, Arizona
- Home OCT-Guided Treatment Versus Treat and Extend for the Management of Neovascular AMD โ Glendale, California
- Safety and Efficacy of ADVM-022 in Treatment-Experienced Patients With Neovascular Age-related Macular Degeneration [LUNA] โ Phoenix, Arizona
Explore by condition: All Neovascular Age-related Macular Degeneration clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.