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RGX-314 Gene Therapy for Wet AMD
Study Summary
This trialis testing a gene therapy to treat Wet AMD, which causes vision loss due to new, leaky blood vessels in the retina. It will compare two different doses of the therapy in humans.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2021 Phase 1 & 2 trial • 42 Patients • NCT03066258Trial Design
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Who is running the clinical trial?
Media Library
- My eye condition was treated with specific injections due to aging.I have previously undergone gene therapy.I had cataract surgery in my study eye more than 12 weeks ago.My doctor thinks nothing will improve my vision in the study eye.I have or had a detached retina or tear in my study eye.I have scarring or tissue loss in the center of my vision in one eye.I am between 50 and 89 years old.My vision loss is not due to AMD but another cause.My condition is advanced glaucoma in one eye.I have not had a heart attack, stroke, or mini-stroke in the last 6 months.I responded well to previous anti-VEGF therapy.
- Group 1: Commercial Formulation Dose 1
- Group 2: Clinical Formulation Dose 1
- Group 3: Commercial Formulation Dose 2
- Group 4: Clinical Formulation Dose 2
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
Are the parameters of this research experiment compatible with my qualifications?
"This clinical trial seeks 60 individuals aged 50 to 89 with wet macular degeneration. Eligibility is limited to males and females who possess a Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA-letter score of 40 or higher and 78 or lower in the study eye at Screening, have been previously treated with anti-VEGF agents, attained meaningful response to these interventions, are pseudophakic for 12 weeks minimum in the study eye, and agree via signed informed consent that they will participate."
Are the elderly allowed to enter this research study?
"The age range for inclusion in this medical trial is 50 to 89. There are 10 trials specifically designed for those below 18, and 153 clinical studies tailored towards the over 65 demographic."
Is recruitment currently being conducted for this research endeavor?
"According to the information sourced from clinicaltrials.gov, this medical trial is currently recruiting new participants. The initial posting of this study was on February 22nd 2021 and it has been updated most recently on November 21st 2022."
What is the maximum enrolment for this research project?
"That is correct. According to clinicaltrials.gov, this research study began recruiting on February 22nd 2021 and its most recent update was made November 21st 2022; with the aim of enrolling 60 participants from 26 varying sites."
Has RGX-314 received clearance from the FDA?
"Due to the Phase 2 status of RGX-314, there is some evidence for safety yet no confirmation regarding efficacy; thus, our team at Power assigned it a rating of 2."
Are there many sites in America hosting this trial?
"Patients can enroll in this clinical research study at Ophthalmic Consultants of Boston (Boston, MA), Sierra Eye Associates (Reno, NV) and Charles Retina Institute (Germantown, TN). An additional 26 sites are also participating."
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