Status:
RECRUITING
Pivotal 1 Study of ABBV-RGX-314 (Also Known as RGX-314) Gene Therapy Administered Via Subretinal Delivery One Time in Participants With nAMD
Lead Sponsor:
AbbVie
Collaborating Sponsors:
REGENXBIO Inc.
Conditions:
AMD
nAMD
Eligibility:
All Genders
50-89 years
Phase:
PHASE2
PHASE3
Brief Summary
ABBV-RGX-314 (also known as RGX-314) is being developed as a novel one-time gene therapy for the treatment of neovascular (wet) age-related macular degeneration (wet AMD or nAMD). Wet AMD is character...
Detailed Description
This randomized, partially masked, active-controlled, Phase 2b/3 clinical study will evaluate the efficacy and safety of ABBV-RGX-314 gene therapy in participants with nAMD. The study will evaluate 2 ...
Eligibility Criteria
Inclusion
- Age ≥ 50 years and ≤ 89 years
- An ETDRS BCVA letter score between ≤ 78 and ≥ 40 in the study eye
- Diagnosis of subfoveal CNV secondary to AMD in the study eye previously treated with anti-VEGF
- Must be pseudophakic (at least 12 weeks postcataract surgery) in the study eye.
- Willing and able to provide written, signed informed consent for this study
- Participants must have demonstrated a meaningful response to anti-VEGF therapy at study entry
- Inclusion Criteria (Bilateral Treatment Substudy)\*:
- An ETDRS BCVA letter score between ≤ 83 and ≥ 40 in both eyes
- Diagnosis of subfoveal choroidal neovascularization (CNV) secondary to AMD in both eyes
- Must be pseudophakic (at least 12 weeks postcataract surgery) in both eyes
- Willing and able to provide written, signed informed consent for this study
- Newcomers must have active disease in the study eye; crossover participants must have active disease in the eye not treated in the main study
Exclusion
- CNV or macular edema in the study eye secondary to any causes other than AMD
- Subfoveal fibrosis or atrophy in the study eye, as determined by CRC
- Any condition in the investigator's opinion that could limit VA improvement in the study eye
- Active or history of retinal detachment, or current retinal tear that cannot be treated, in the study eye
- Advanced glaucoma or history of secondary glaucoma in the study eye
- History of intraocular surgery in the study eye within 12 weeks prior to randomization
- History of intravitreal therapy in the study eye, such as intravitreal steroid injection or investigational product, other than anti-VEGF therapy, in the 6 months prior to Screening Visit 1
- Prior treatment with gene therapy
- Recent myocardial infarction, cerebrovascular accident, or transient ischemic attack within the past 6 months
- Exclusion Criteria (Bilateral Treatment Substudy)\*:
- CNV or macular edema in either eye secondary to any causes other than AMD
- Subfoveal fibrosis or atrophy in either eye
- Any condition in the investigator's opinion that could limit VA improvement in either eye
- Active or history of retinal detachment, or current retinal tear that cannot be treated in either eye
- Advanced glaucoma or history of secondary glaucoma in either eye
- Myocardial infarction, cerebrovascular accident, or transient ischemic attack within the past 6 months
- History of intraocular surgery in either eye within 12 weeks prior to randomization
- History of intravitreal therapy in either eye, such as intravitreal steroid injection or investigational product, other than anti-VEGF therapy, in the 6 months prior to screening
- Prior treatment with gene therapy (\*) For previously treated crossover participants, criteria apply to the eye not treated in the main study only.
Key Trial Info
Start Date :
December 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2027
Estimated Enrollment :
630 Patients enrolled
Trial Details
Trial ID
NCT04704921
Start Date
December 29 2020
End Date
November 1 2027
Last Update
August 20 2025
Active Locations (89)
Enter a location and click search to find clinical trials sorted by distance.
1
Retinal Research Institute /ID# 256019
Phoenix, Arizona, United States, 85053
2
Barnet Dulaney Perkins Eye Center - Sun City /ID# 256055
Sun City, Arizona, United States, 85351
3
University of Arkansas for Medical Sciences /ID# 271290
Little Rock, Arkansas, United States, 72205
4
Retina Vitreous Assoc Med Grp /ID# 256299
Beverly Hills, California, United States, 90211