Your session is about to expire
← Back to Search
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%
Conjunctival Haemorrhage
33%
Photopsia
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
Find a Location
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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are participants in this research project required to be under 75 years old?
"Elderly individuals that are within 10 years of the age limit are being sought out for this study."
Answered by AI
In how many different locations is this trial being conducted?
"There are four main sites for this trial: Houston Location in Houston, Texas, Madison Location in Madison, Wisconsin, Pasadena Location in Pasadena, California. Additionally, there are 67 other locations where the study is taking place."
Answered by AI
Could I qualify to participate in this research?
"This study is recruiting 300 patients aged 50-89 with AMD. The most notable requirements for participants are as follows: the ability to provide written informed consent, previous treatment of subfoveal CNV related to AMD with anti-VEGF therapy, pseudophakic status in the study eye (at least 12 weeks post-cataract surgery), and a demonstrated response to anti-VEGF therapy at study entry."
Answered by AI
For what type of ailment is RGX-314 most commonly prescribed?
"RGX-314 is not only useful for branch vein occlusion, but also other medical conditions such as wet age-related macular degeneration (wamd), macular edema, and myopic choroidal neovascularization."
Answered by AI
Could you walk me through the other times RGX-314 has been used in research?
"RGX-314 was first explored in 2008 at the Ludwig Boltzmann Institute for Retinology and Biomicroscopic Lasersurgery. As of now, there have been a total of 311 completed studies. 33 more are currently recruiting patients, many located in Houston, Texas."
Answered by AI
Are researchers still looking for more people to participate in this clinical trial?
"Yes, this is an ongoing trial that was originally posted on December 29th, 2020. To date, the 67 clinical sites recruiting for this trial have enrolled 300 participants."
Answered by AI
Who else is applying?
What state do they live in?
Ontario
Florida
Other
Mississippi
How old are they?
65+
What site did they apply to?
San Francisco 2 Location
Miami Location
Germantown Location
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
0
3+
Why did patients apply to this trial?
For my health. I have an acclusion in my left eye. What motivates me that can be part of a cure for me and my mother and thousands of people.
PatientReceived 2+ prior treatments
I feel confident that the DNA implantation will be successful and I want to be able to see well enough to read music and play the organ and piano again.
PatientReceived no prior treatments
I've had the Eylea shots in the right eye from 2019 -2021. They were helpful but I believe that gene-therapy treatment would be restorative. I am excited about the possibility!
PatientReceived no prior treatments
What questions have other patients asked about this trial?
How does the trail work? How many trips would I need to make to Pensacola?
PatientReceived 1 prior treatment
When will screening visits be scheduled and how long would I need to plan to be in the city?
PatientReceived no prior treatments
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger