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Gene Therapy
RGX-314 Gene Therapy for Wet Age-Related Macular Degeneration (ATMOSPHERE Trial)
Phase 2 & 3
Recruiting
Research Sponsored by REGENXBIO, Inc.
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 26, week 38, week 54, and week 98
Awards & highlights
ATMOSPHERE Trial Summary
This trial is studying a new gene therapy called RGX-314 for wet age-related macular degeneration. Wet AMD is when new, leaky blood vessels form in the retina and cause vision loss. Current treatments require life-long intraocular injections, typically repeated every four to twelve weeks, to maintain efficacy. RGX-314 is being developed as a potential one-time treatment for wet AMD.
Who is the study for?
This trial is for people aged 50-89 with wet age-related macular degeneration (AMD) who've had a positive response to anti-VEGF therapy. They must have certain vision scores, be pseudophakic post-cataract surgery, and able to consent. Excluded are those with other eye conditions or treatments, gene therapy history, or recent severe cardiovascular events.Check my eligibility
What is being tested?
The study tests RGX-314, a potential one-time gene therapy for wet AMD against Ranibizumab (LUCENTIS®), the current standard requiring frequent injections. The goal is to see if RGX-314 can maintain vision without regular treatments.See study design
What are the potential side effects?
While specific side effects of RGX-314 aren't listed here, gene therapies may cause immune reactions, changes in vision, discomfort at injection site or inflammation inside the eye.
ATMOSPHERE 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 have shown improvement with anti-VEGF therapy.
Select...
My eye condition was treated with injections due to AMD.
ATMOSPHERE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at week 14, week 26, week 38, week 54, and week 98
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 14, week 26, week 38, week 54, and week 98
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 target protein (TP) concentrations
Incidences of ocular and overall adverse events (AEs)
Mean change from baseline in BCVA
+3 moreSide effects data
From 2021 Phase 1 & 2 trial • 42 Patients • NCT0306625867%
Retinal Haemorrhage
67%
Intraocular Inflammation
50%
Visual Acuity Reduced/Impairment
33%
Photopsia
33%
Conjunctival Haemorrhage
17%
Pneumonia
17%
Eye Pain
17%
Hypervolaemia
17%
Arthritis
17%
Respiratory Failure
17%
Intraocular Pressure Increased
17%
Vision Blurred
17%
Dry Age-Related Macular Degeneration
17%
Photophobia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1
Cohort 4
Cohort 2
Cohort 3
Cohort 5
ATMOSPHERE 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
Ranibizumab administered via intravitreal injection approximately every 28 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RGX-314
2021
Completed Phase 2
~110
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Age-Related Macular Degeneration (AMD) include anti-VEGF (vascular endothelial growth factor) therapies, which work by inhibiting the growth of abnormal blood vessels in the retina that cause vision loss. These treatments, such as ranibizumab and aflibercept, require frequent intraocular injections to maintain their efficacy.
RGX-314, a gene therapy under investigation, aims to provide a one-time treatment that enables sustained anti-VEGF expression, potentially reducing the treatment burden and improving long-term outcomes for patients. This is significant for AMD patients as it could lead to more consistent management of the disease and better preservation of vision with fewer interventions.
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Who is running the clinical trial?
REGENXBIO, Inc.Lead Sponsor
19 Previous Clinical Trials
1,993 Total Patients Enrolled
Regenxbio Inc.Lead Sponsor
19 Previous Clinical Trials
1,993 Total Patients Enrolled
REGENXBIO Inc.Lead Sponsor
23 Previous Clinical Trials
2,235 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had a heart attack, stroke, or mini-stroke in the last 6 months.I am between 50 and 89 years old.I have not had eye surgery in the past 3 months.I have not had any eye injections except for anti-VEGF in the last 6 months.I have or had a detached retina in my eye being studied.My glaucoma in one eye is not under control.I had cataract surgery in my study eye more than 12 weeks ago.You have a condition that might prevent your study eye from getting better, according to the doctor.I have shown improvement with anti-VEGF therapy.I have scarring or tissue loss in the center of my vision in one eye.My vision loss is not due to AMD but another cause.My eye condition was treated with injections due to AMD.I have previously undergone gene therapy.
Research Study Groups:
This trial has the following groups:- Group 1: RGX-314 Dose 1
- Group 2: RGX-314 Dose 2
- Group 3: Control Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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: NCT04704921 — Phase 2 & 3
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