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Gene Therapy
RGX-314 Gene Therapy for Age-Related Macular Degeneration (ASCENT Trial)
Phase 3
Recruiting
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 50 years and ≤ 89 years
Participants must have demonstrated a meaningful response to anti-VEGF therapy at study entry
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 14, week 38, week 54, week 74, week 90 and week 108
Awards & highlights
ASCENT Trial Summary
This trial is testing a new gene therapy for age-related macular degeneration, which is a leading cause of blindness. The therapy involves a one-time injection and has the potential to improve vision for people with this condition.
Who is the study for?
This trial is for people aged 50-89 with wet age-related macular degeneration (AMD) who've had cataract surgery at least 12 weeks ago and responded to previous anti-VEGF treatments. They should have a certain level of vision as measured by the ETDRS score. Those with recent serious heart events, retinal detachment, other eye conditions or surgeries, or prior gene therapy can't join.Check my eligibility
What is being tested?
The study tests RGX-314, a one-time gene therapy for wet AMD that could replace frequent injections currently needed for treatment. Two different doses of RGX-314 are being compared against Aflibercept (EYLEA®), an existing standard care medication.See study design
What are the potential side effects?
While specific side effects of RGX-314 aren't listed here, gene therapies can sometimes cause immune reactions, changes in vision, discomfort at the injection site, and potential long-term risks which are still unknown.
ASCENT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 50 and 89 years old.
Select...
I responded well to previous anti-VEGF treatment.
Select...
My eye condition was treated with injections due to AMD.
ASCENT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at week 14, week 38, week 54, week 74, week 90 and week 108
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 14, week 38, week 54, week 74, week 90 and week 108
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean change from baseline in Best Corrected Visual Acuity (BCVA)
Secondary outcome measures
Aqueous RGX-314 TP concentrations
Incidences of ocular and overall Serious Adverse Events (SAEs)
Mean change from baseline in BCVA
+3 moreASCENT Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: RGX-314 Dose 2Experimental Treatment1 Intervention
RGX-314 Dose 2 administered via subretinal delivery one time.
Group II: RGX-314 Dose 1Experimental Treatment1 Intervention
RGX-314 Dose 1 administered via subretinal delivery one time.
Group III: Control ArmActive Control1 Intervention
Aflibercept administered via intravitreal injection approximately every 8 weeks
Find a Location
Who is running the clinical trial?
AbbVieLead Sponsor
958 Previous Clinical Trials
501,925 Total Patients Enrolled
REGENXBIO, Inc.Lead Sponsor
19 Previous Clinical Trials
1,828 Total Patients Enrolled
Regenxbio Inc.Lead Sponsor
19 Previous Clinical Trials
1,828 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had cataract surgery in my study eye more than 12 weeks ago.I had cataract surgery in my study eye over 12 weeks ago.I have previously undergone gene therapy.I am between 50 and 89 years old.I have advanced glaucoma or a history of it in one eye.My vision loss is not due to AMD but another cause.I responded well to previous anti-VEGF treatment.I have scarring or tissue loss in the center of my vision in one eye.I have not had eye surgery in the past 3 months.I have not had a heart attack, stroke, or mini-stroke in the last 6 months.My eye condition was treated with injections due to AMD.I have or had a detached retina or currently have a tear in my study eye.I haven't had any eye injections except for anti-VEGF in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: RGX-314 Dose 2
- Group 2: Control Arm
- Group 3: RGX-314 Dose 1
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Age-Related Macular Degeneration Patient Testimony for trial: Trial Name: NCT05407636 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are we still taking in new participants for this experiment?
"The trial, which is still recruiting patients according to information on clinicaltrials.gov, was first posted on December 28th, 2021 and was last updated on June 2nd, 2022."
Answered by AI
Does this research project include middle-aged adults as test subjects?
"In order to meet the requirements for this particular clinical trial, applicants must be aged 50 to 89. Out of the 177 total clinical trials, this is one of 11 that is meant for people under 18 and 166 for people over 65."
Answered by AI
What is the most recent decision by the FDA regarding RGX-314 Dose 2?
"RGX-314 Dose 2 is safe according to our 3-point scale because it is a Phase 3 trial, meaning that there is both efficacy and safety data supporting its use."
Answered by AI
Who would this research be most applicable to?
"This particular trial is looking for 465 individuals that currently suffer from amd. The ages of these patients must be between 50 and 89 years old. Furthermore, they must meet the following other criteria: -An ETDRS BCVA letter score between ≤ 78 and ≥ 40 in the study eye -A diagnosis of subfoveal CNV secondary to AMD in the study eye that has been previously treated with anti-VEGF -Pseudophakic in the study eye (at least 12 weeks postcataract surgery) -Able and willing to provide written, signed informed consent"
Answered by AI
Who else is applying?
What state do they live in?
Ontario
Hawaii
Florida
Other
How old are they?
65+
What site did they apply to?
Santa Ana Location
Gainesville Location
'Aiea location
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
0
3+
Why did patients apply to this trial?
My eyesight is getting worse and I have been on Eylea for more than 6 years.
PatientReceived 2+ prior treatments
It listed a Gainesville, Fl location which was not available during the final survey questions. I have Wet AMD in right eye and dry AMD in both.
PatientReceived 1 prior treatment
I'm confident that this procedure will benefit me. I want to see my children and grandchildren more clearly, read music as before to play piano and organ, and not be dependent on others for needs.
PatientReceived 2+ prior treatments
I have AMD and want to: 1) keep it from progressing if I can, and 2) help us all to find ways to treat and even lessen the risk of AMD. I am at high risk of going blind from AMD. My mother and all 3 of her sisters had AMD, but my sisters and cousins to not.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
Yes. When can I get in the Gainesville trial? How long would I be in Pensacola for the initial visit, for the treatment and for follow-up?
PatientReceived 1 prior treatment
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