BridgeMD
A Randomized, Partially Masked, Controlled, Phase 3 Clinical Study to Evaluate the Efficacy and Safety of RGX-314 Gene Therapy in Participants with nAMD (ASCENT)
EU CTIS ID: 2023-503666-23-00
What this study is testing
To evaluate the noninferiority of ABBV-RGX-314 relative to aflibercept in mean change from Baseline BCVA at Week 54
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1-Age ≥ 50 years and ≤ 89 years
- 2-An ETDRS BCVA letter score between ≤ 78 and ≥ 40 in the study eye at Week –6 (Screening Visit 1).
- 3-Diagnosis of CNV secondary to AMD in the study eye. Since nAMD diagnosis, must have received a minimum of 1 intravitreal anti-VEGF injection in the study eye prior to Week –6 (Screening Visit 1) and been responsive.
- 4-Must be pseudophakic (at least 12 weeks postcataract surgery at Week –2 [Randomization; Screening Visit 3]) in the study eye.
- 5-Willing and able to provide written, signed informed consent for this study and must not be incarcerated. (Note: adults under legal protection measure [eg, under guardianship/curatorship] and adults unable to express their consent are not able to participate). Investigator's discretion should be applied.
- 6-Participants must have demonstrated a meaningful response to anti-VEGF therapy at study entry
You likely can't join if
- 1-CNV or macular edema in the study eye secondary to any causes other than AMD
- 10-Prior treatment with gene therapy
- 2-Subfoveal fibrosis or atrophy in the study eye
- 3-Any condition in the investigator's opinion that could limit VA improvement in the study eye
- 4-Active or history of retinal detachment or current retinal tear in the study eye
- 5-Advanced glaucoma or history of secondary glaucoma in the study eye
See the full eligibility criteria
- 1-Age ≥ 50 years and ≤ 89 years
- 2-An ETDRS BCVA letter score between ≤ 78 and ≥ 40 in the study eye at Week –6 (Screening Visit 1).
- 3-Diagnosis of CNV secondary to AMD in the study eye. Since nAMD diagnosis, must have received a minimum of 1 intravitreal anti-VEGF injection in the study eye prior to Week –6 (Screening Visit 1) and been responsive.
- 4-Must be pseudophakic (at least 12 weeks postcataract surgery at Week –2 [Randomization; Screening Visit 3]) in the study eye.
- 5-Willing and able to provide written, signed informed consent for this study and must not be incarcerated. (Note: adults under legal protection measure [eg, under guardianship/curatorship] and adults unable to express their consent are not able to participate). Investigator's discretion should be applied.
- 6-Participants must have demonstrated a meaningful response to anti-VEGF therapy at study entry
- 1-CNV or macular edema in the study eye secondary to any causes other than AMD
- 10-Prior treatment with gene therapy
- 2-Subfoveal fibrosis or atrophy in the study eye
- 3-Any condition in the investigator's opinion that could limit VA improvement in the study eye
- 4-Active or history of retinal detachment or current retinal tear in the study eye
- 5-Advanced glaucoma or history of secondary glaucoma in the study eye
- 6-Myocardial infarction, cerebrovascular accident, or transient ischemic attack within the past 6 months
- 7-Other clinically significant, active systemic or localized infections at any screening visit that may compromise the participant's safety or interpretation of results such as: mycobacterial, fungal, or viral infections (eg, HIV, hepatitis B or C, SARS-CoV-2 2019 [COVID-19], Epstein-Barr virus, syphilis, HSV, varicella-zoster virus, CMV).
- 8-History of intraocular surgery in the study eye within 12 weeks prior to Week –2 (Randomization; Screening Visit 3). Yttrium aluminum garnet capsulotomy is permitted if performed > 10 weeks prior to the Week –6 (Screening Visit 1).
- 9-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.
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- Japan
- United States
- Israel
- United Kingdom
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; Japan; United States; Israel; United Kingdom. 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 EU CTIS; the study team decides eligibility.