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RGX-314 Gene Therapy for Age-Related Macular Degeneration (AAVIATE Trial)
AAVIATE Trial Summary
This trial is evaluating a potential new treatment for a disease that causes vision loss. The current standard of care for this disease requires life-long, repeated injections to maintain efficacy, but this new treatment would only require a single injection.
AAVIATE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.AAVIATE Trial Design
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Who is running the clinical trial?
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- You are between 50 and 89 years old.You have a vision condition called "age-related macular degeneration" that has led to abnormal blood vessels in your study eye.You are able to read and sign a document that explains the details of the study and agree to participate.You have previously received anti-VEGF therapy and it was effective in treating your condition.
- Group 1: Ranibizumab control
- Group 2: RGX-314 Treatment Arm (Dose 1)
- Group 3: RGX-314 Treatment Arm (Dose 2)
- Group 4: RGX-314 Treatment Arm (Dose 3)
- Group 5: RGX-314 Treatment Arm (Dose 3) and Local Steroid
- Group 6: RGX-314 Treatment Arm (Dose 3) and Topical Steroid
- 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
Is this research endeavor enrolling participants that are octogenarian or older?
"This clinical trial is seeking participants aged 50 to 89 as it meets the inclusion criteria. For those under 18 or over 65, there are 11 and 186 trials respectively available for them."
Are there currently opportunities to participate in this experiment?
"Correct. Information accessible on clinicaltrials.gov suggests that this medical trial, which began recruitment efforts in late August of 2020, is still actively seeking participant enrolment. To date, 115 volunteers are needed to participate at 10 distinct locations."
How many participants are currently partaking in this research endeavor?
"This study necessitates the recruitment of 115 suitable participants, with multiple sites available such as Philadelphia Location in Pennsylvania and Reno Location in Nevada."
Has the FDA sanctioned RGX-314 Dose 2 for therapeutic use?
"With preliminary safety data available, our team at Power assigned RGX-314 Dose 2 a score of 2 on their scale from 1 to 3. This rating implies that there is evidence for its security but further studies need to be conducted in order to assess efficacy."
To what health issue is RGX-314 Dose 2 typically utilized as a treatment?
"RGX-314 Dose 2 has been approved to treat branch vein occlusion, and can also provide relief for wAMD, macular edema, and myopic choroidal neovascularization."
What sort of participants are desired for this medical experiment?
"This trial is recruiting 115 volunteers with choroidal effusions ranging from 50 to 89 years old. To qualify, the applicants must be within this age range and have a documented diagnosis of CNV resulting from AMD in their study eye. Additionally, they need to have responded positively to anti-VEGF treatment as well as given written consent for the experiment's inclusion."
Is there widespread implementation of this trial in Canadian healthcare facilities?
"At the present time, this clinical trial is enrolling out of 10 sites. These include Philadelphia, Reno and Augusta amongst other places. To reduce travelling needs should you choose to participate, it's beneficial to select the closest site."
Are there any other reports regarding the efficacy of RGX-314 Dose 2?
"Since its initial study at Ludwig Boltzmann Institute for Retinology and Biomicroscopic Lasersurgery in 2008, RGX-314 Dose 2 has been the subject of 314 separate clinical trials. At present there are 31 studies actively recruiting patients; many of these initiatives taking place in Philadelphia, Pennsylvania."
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