NCT04832724CompletedPhase 2
RGX-314 Gene Therapy Pharmacodynamic Study for Neovascular Age-related Macular Degeneration (nAMD)
A Phase 2, Open-label Study to Explore the Pharmacodynamics of Two Doses in Two Formulations of RGX-314 Gene Therapy Administered Via Subretinal Delivery in Participants With Neovascular Age-related Macular Degeneration
Source: ClinicalTrials.gov · Last updated 5 Sept 2024
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 30 Mar 2021
- Start date
- Feb 2021
- Primary completion date
- Oct 2023
- Lead sponsor
- AbbVie
- Diseases
- Macular degeneration
- NCT number
- NCT04832724
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 60
- From Feb 2021 to the primary completion date, Oct 2023
- 13 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with gene therapy.
Other illness
- 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.
- Myocardial infarction, cerebrovascular accident, or transient ischemic attack within the past 6 months.
Other
- CNV or macular edema in the study eye secondary to any causes other than AMD.
- Subfoveal fibrosis or atrophy in study eye.
- Advanced glaucoma in the study eye.
Who the study is looking for
- 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.
Age in the registry: 50 years to 89 years · Sex: All · Does not accept healthy volunteers
Sites (13)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Eye Associates of New Mexico Coordinator of this site? Confirm its status | Albuquerque | United States | Unknown status |
| Wilmer Eye Institute Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Ophthalmic Consultants of Boston Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Texas Retina Associates Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Charles Retina Institute Coordinator of this site? Confirm its status | Germantown | United States | Unknown status |
| Wills Eye Hospital Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Retinal Consultants of Arizona Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Sierra Eye Associates Coordinator of this site? Confirm its status | Reno | United States | Unknown status |
| Retina Consultants of San Diego Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
| California Retina Consultants Coordinator of this site? Confirm its status | Santa Barbara | United States | Unknown status |
| Retina Vitreous Associates of Florida Coordinator of this site? Confirm its status | St. Petersburg | United States | Unknown status |
| Barnet Dulaney Perkins Eye Center Coordinator of this site? Confirm its status | Sun City | United States | Unknown status |
| Retina Consultants of Texas Coordinator of this site? Confirm its status | The Woodlands | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.