Status:
RECRUITING
RGX-314 Gene Therapy Administered in the Suprachoroidal Space for Participants With Neovascular Age-Related Macular Degeneration (nAMD)
Lead Sponsor:
AbbVie
Collaborating Sponsors:
REGENXBIO Inc.
Conditions:
Neovascular Age-Related Macular Degeneration (nAMD)
Eligibility:
All Genders
50-89 years
Phase:
PHASE2
Brief Summary
This interventional study is being conducted with an investigational gene therapy treatment called ABBV-RGX-314 (also known as RGX-314) and is being developed as a potential one-time gene therapy trea...
Detailed Description
This phase 2, randomized, dose-escalation study is designed to evaluate the efficacy, safety and tolerability of ABBV-RGX-314 gene therapy in subjects with nAMD. ABBV-RGX-314 will be injected into th...
Eligibility Criteria
Inclusion
- Age \>/= 50 and \</= 89
- Diagnosis of CNV secondary to age-related macular degeneration in the study eye.
- Participants must have demonstrated a meaningful response to anti-VEGF therapy.
- Willing and able to provide written, signed informed consent for this study.
Exclusion
- CNV or macular edema in the study eye secondary to any causes other than AMD.
- Subfoveal fibrosis or atrophy in study eye.
- Participants who have had a prior vitrectomy.
- Active or history of retinal detachment in the study eye.
- History of intravitreal therapy in the study eye, such as intravitreal steroid injection or investigational product (IP), other than anti-VEGF therapy, in the 6 months prior to study entry.
- Received any gene therapy.
- Any condition preventing visualization of the fundus or VA improvement in the study eye, eg, cataract.
- History of intraocular surgery in the study eye within 12 weeks of study entry.
- Receipt of any IP within 30 days of study entry or 5 half-lives of the IP.
- Myocardial infarction, cerebrovascular accident, or transient ischemic attacks within 6 months of study entry.
- Cohorts 1 - 5 only: Uncontrolled glaucoma in the study eye.
- COHORT 6 AND 7 ONLY:
- Active or history of glaucoma or ocular hypertension (steroid-induced ocular hypertension (Cohort 7 only)) in the study eye.
- Certain OCT characteristics including: Large Pigment Epithelial Detachments (PED), clinically significant Epiretinal Membrane (ERM) in the study eye at Visit 1.
- Note: Other inclusion/exclusion criteria apply.
Key Trial Info
Start Date :
August 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT04514653
Start Date
August 25 2020
End Date
February 1 2027
Last Update
November 14 2025
Active Locations (18)
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1
Retinal Research Institute /ID# 255925
Phoenix, Arizona, United States, 85053
2
California Retina Consultants - Bakersfield /ID# 255910
Bakersfield, California, United States, 93309-1677
3
Retina Vitreous Assoc Med Grp /ID# 255921
Beverly Hills, California, United States, 90211
4
Retinal Diagnostic Center /ID# 272275
Campbell, California, United States, 95008