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New treatment option for AMD
Official title Pivotal 2 Study of RGX-314 Gene Therapy in Participants With nAMD
ClinicalTrials.gov ID: NCT05407636
What this study is testing
What is ABBV-RGX-314 Dose 1?
ABBV-RGX-314 Dose 1 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for amd.
Also referred to as RGX-314, surabgene lomparvovec.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- ABBV-RGX-314 (also known as RGX-314 and surabgene lomparvovec (sura-vec)) is being developed as a novel one-time gene therapy for the treatment of neovascular (wet) age-related macular degeneration (wet AMD). Wet AMD is characterized by loss of vision due to new, leaky blood vessel formation in the retina.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 89
You may be able to join if
- Age ≥ 50 years and ≤ 89 years
- An ETDRS BCVA letter score between ≤ 78 and ≥ 40 in the study eye
- Diagnosis of subfoveal choroidal neovascularization (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
You likely can't join if
- CNV or macular edema in the study eye secondary to any causes other than AMD
- Subfoveal fibrosis or atrophy in the study eye
- Any condition in the investigator's opinion that could limit VA improvement in the study eye
- Advanced glaucoma or history of secondary glaucoma in the study eye
- Myocardial infarction, cerebrovascular accident, or transient ischemic attack within the past 6 months
- History of intraocular surgery in the study eye within 12 weeks prior to randomization
See the full eligibility criteria
- Age ≥ 50 years and ≤ 89 years
- An ETDRS BCVA letter score between ≤ 78 and ≥ 40 in the study eye
- Diagnosis of subfoveal choroidal neovascularization (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 (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
- CNV or macular edema in the study eye secondary to any causes other than AMD
- Subfoveal fibrosis or atrophy in the study eye
- Any condition in the investigator's opinion that could limit VA improvement in the study eye
- Advanced glaucoma or history of secondary glaucoma in the study eye
- Myocardial infarction, cerebrovascular accident, or transient ischemic attack within the past 6 months
- 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 medicinal product, other than an intravitreal therapy for AMD, in the 6 months prior to Week -6
- Prior treatment with gene therapy 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
- 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 the study eye, such as intravitreal steroid injection or investigational medicinal product, other than an intravitreal therapy for AMD, in the 6 months prior to Week -6.
- Prior treatment with gene therapy (\ ) For previously treated crossover participants, criteria apply to the eye not treated in the main study only. Note: Other inclusion/exclusion criteria apply
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Scottsdale, Arizona, United States
- Bakersfield, California, United States
- Beverly Hills, California, United States
- Campbell, California, United States
- Encino, California, United States
- Fullerton, California, United States
- La Jolla, California, United States
- Oxnard, California, United States
- Palo Alto, California, United States
- Poway, California, United States
- Riverside, California, United States
- Sacramento, California, United States
- Santa Ana, California, United States
- Torrance, California, United States
- Walnut Creek, California, United States
- Colorado Springs, Colorado, United States
- Durango, Colorado, United States
- Lakewood, Colorado, United States
- Longmont, Colorado, United States
+ 143 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 89 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Scottsdale, Arizona, United States; Bakersfield, California, United States; Beverly Hills, California, United States; Campbell, California, United States; Encino, California, United States and 157 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.