RGX-314 Gene Therapy Administered in the Suprachoroidal Space for Participants With Neovascular Age-Related Macular Degeneration (nAMD) (AAVIATE)

Launched by ABBVIE · Aug 14, 2020

Keywords

ClinConnect Summary

This clinical trial, called AAVIATE, is studying a new one-time gene therapy called RGX-314 for people with neovascular age-related macular degeneration (nAMD), which is a condition that can cause significant vision loss due to the growth of abnormal blood vessels in the eye. The goal of this trial is to see if RGX-314 can provide an effective treatment alternative to the current standard, which involves regular eye injections that many patients find burdensome. The trial is currently recruiting participants aged 50 to 89 who have shown a positive response to existing treatments but still experience vision issues.

To be eligible for the trial, participants must have nAMD and be willing to provide consent to join the study. They should not have certain other eye conditions or recent eye surgeries that could interfere with the study. If chosen to participate, individuals will receive the RGX-314 treatment and will be monitored to track its effectiveness and any side effects. This trial represents an exciting opportunity for patients seeking new ways to manage their vision loss with potentially less frequent treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age \>/= 50 and \</= 89
• • Diagnosis of CNV secondary to age-related macular degeneration in the study eye.
• • Participants must have demonstrated a meaningful response to anti-VEGF therapy.
• • Willing and able to provide written, signed informed consent for this study.
• Exclusion Criteria:
• • CNV or macular edema in the study eye secondary to any causes other than AMD.
• • Subfoveal fibrosis or atrophy in study eye.
• • Participants who have had a prior vitrectomy.
• • Active or history of retinal detachment in the study eye.
• • History of intravitreal therapy in the study eye, such as intravitreal steroid injection or investigational product (IP), other than anti-VEGF therapy, in the 6 months prior to study entry.
• • Received any gene therapy.
• • Any condition preventing visualization of the fundus or VA improvement in the study eye, eg, cataract.
• • History of intraocular surgery in the study eye within 12 weeks of study entry.
• • Receipt of any IP within 30 days of study entry or 5 half-lives of the IP.
• • Myocardial infarction, cerebrovascular accident, or transient ischemic attacks within 6 months of study entry.
• • Cohorts 1 - 5 only: Uncontrolled glaucoma in the study eye.
• COHORT 6 ONLY:
• • Active or history of glaucoma or ocular hypertension in the study eye.
• • Certain OCT characteristics including: Large Pigment Epithelial Detachments (PED), clinically significant Epiretinal Membrane (ERM) in the study eye at Visit 1.
• • Note: Other inclusion/exclusion criteria apply.