RGX-314 Gene Therapy Pharmacodynamic Study for Neovascular Age-related Macular Degeneration (nAMD)
Completed · Phase 2
Conditions studied: Neovascular Age-related Macular Degeneration, Wet Macular Degeneration, Wet Age-related Macular Degeneration
In brief
RGX-314 is being developed as a novel one-time gene therapy for the treatment of neovascular (wet) age-related macular degeneration (nAMD) also referred to as Wet AMD. Wet AMD is characterized by loss of vision due to new, leaky blood vessel formation in the retina. The purpose of this phase 2, open label study is to evaluate whether different doses of RGX-314 from two different formulations (clinical versus eventual commercial formulation) perform the same in humans when delivered by subretinal administration
Key facts
- Study ID
- NCT04832724
- Run by
- AbbVie
- People needed
- 60
- Starts
- 2021-02-22
- Expected to finish
- 2024-03-18
- Last updated by the study team
- 2024-09-05
Who can join
Age: 50 and older, up to 89. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Males or females, aged ≥ 50 years and ≤ 89 years.
- An Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA-letter score between ≤ 78 and ≥ 40 in the study eye at Screening.
- Diagnosis of choroidal neovascularization (CNV) secondary to age-related macular degeneration in the study eye previously treated with anti-VEGF.
- Participants must have demonstrated a meaningful response to anti-VEGF therapy at study entry.
- Willing and able to provide written, signed informed consent for this study.
- Must be pseudophakic (at least 12 weeks postcataract surgery) in the study eye.
You may not qualify if…
- CNV or macular edema in the study eye secondary to any causes other than AMD.
- Subfoveal fibrosis or atrophy in study eye.
- Any condition in the investigator's opinion that could limit visual acuity improvement in the study eye.
- Active or history of retinal detachment or retinal tear in the study eye.
- Advanced glaucoma in the study eye.
- Prior treatment with gene therapy.
- Myocardial infarction, cerebrovascular accident, or transient ischemic attack within the past 6 months.
Where it is running
- Retinal Consultants of Arizona — Phoenix, Arizona, United States
- Barnet Dulaney Perkins Eye Center — Sun City, Arizona, United States
- Retina Consultants of San Diego — San Diego, California, United States
- California Retina Consultants — Santa Barbara, California, United States
- Retina Vitreous Associates of Florida — St. Petersburg, Florida, United States
- Wilmer Eye Institute — Baltimore, Maryland, United States
- Ophthalmic Consultants of Boston — Boston, Massachusetts, United States
- Sierra Eye Associates — Reno, Nevada, United States
- Eye Associates of New Mexico — Albuquerque, New Mexico, United States
- Wills Eye Hospital — Philadelphia, Pennsylvania, United States
- Charles Retina Institute — Germantown, Tennessee, United States
- Texas Retina Associates — Dallas, Texas, United States
- Retina Consultants of Texas — The Woodlands, Texas, United States
Full record on ClinicalTrials.gov
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