Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05407636 · ClinicalTrials.gov registry record · Phase 3
Pivotal 2 Study of RGX-314 Gene Therapy in Participants With nAMD
A Phase 3 study of Wet Age-related Macular Degeneration and AMD, sponsored by AbbVie.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 660
- Enrollment target
- 20
- Study locations
NCT05407636 is a Phase 3 study of Wet Age-related Macular Degeneration and AMD that is actively recruiting participants, run by AbbVie. The registered enrollment target is 660 participants, above the 342-participant average among 8 other Wet Age-related Macular Degeneration trials with a reported enrollment target (93% higher). The trial reports 20 study locations across 3 states.
The verdict
NCT05407636, a Phase 3 study of Wet Age-related Macular Degeneration and AMD, is actively recruiting participants, sponsored by AbbVie.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 660 participants
- Enrollment target
- 20
- Study locations
Study Summary
ABBV-RGX-314 (also known as RGX-314) is being developed as a novel one-time gene therapy for the treatment of neovascular (wet) age-related macular degeneration (wet AMD). Wet AMD is characterized by loss of vision due to new, leaky blood vessel formation in the retina. Wet AMD is a significant cause of vision loss in the United States, Europe and Japan, with up to 2 million people living with wet AMD in these geographies alone. Current anti-vascular endothelial growth factor (VEGF) therapies have significantly changed the landscape for treatment of wet AMD, becoming the standard of care due to their ability to prevent progression of vision loss in the majority of patients. These therapies, however, require life-long intraocular injections, typically repeated every four to 12 weeks in frequency, to maintain efficacy. Due to the burden of treatment, patients often experience a decline in vision with reduced frequency of treatment over time. ABBV-RGX-314 is being developed as a potential one-time treatment for wet AMD.
Interventions
- GENETIC ABBV-RGX-314 Dose 1
- GENETIC ABBV-RGX-314 Dose 2
- BIOLOGICAL Aflibercept (EYLEA®)
Study Locations (20)
California
- California Retina Consultants - Bakersfield /ID# 256240 - Bakersfield
- Retina Vitreous Assoc Med Grp /ID# 256246 - Beverly Hills
- Retinal Diagnostic Center /ID# 256262 - Campbell
- The Retina Partners - Encino /ID# 259660 - Encino
- Retina Consultants of Orange County /ID# 256267 - Fullerton
- Hamilton Glaucoma Center Shiley Eye Center UCSD /ID# 256320 - La Jolla
- California Retina Consultants - Oxnard - North Ventura Road /ID# 262883 - Oxnard
- Byers Eye Institute Stanford /ID# 262853 - Palo Alto
- Retina Consultants of San Diego /ID# 256258 - Poway
- Kaiser Permanente - Riverside Medical Center /ID# 262413 - Riverside
- University of California Davis Health /ID# 256317 - Sacramento
- Retinal Consultants Medical Group, Inc. - Greenback /ID# 256353 - Sacramento
- Orange County Retina Medical Group /ID# 256286 - Santa Ana
- Macula Retina Vitreous Center - Torrance /ID# 270247 - Torrance
- Bay Area Retina Associates - Walnut Creek - Lennon Lane /ID# 268513 - Walnut Creek
Arizona
- Barnet Dulaney Eye Center-Phoenix /ID# 256340 - Phoenix
- Retinal Research Institute /ID# 256238 - Phoenix
- Retina Macula Institute of Arizona /ID# 271026 - Scottsdale
Colorado
- Retina Consultants of Southern Colorado /ID# 256285 - Colorado Springs
- Southwest Retina Research Center /ID# 256261 - Durango
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 660 participants |
| Start Date | 2022-01-13 |
| Est. Completion | 2027-11 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05407636
The ClinicalTrials.gov registry entry for NCT05407636 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 660 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 342-participant average among 8 other Wet Age-related Macular Degeneration trials with a reported enrollment target (93% higher). The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.
The record links to 6 conditions, with Wet Age-related Macular Degeneration appearing as the primary indexed condition, and to 3 interventions - of which ABBV-RGX-314 Dose 1 is the first listed.
NCT05407636 reports 20 study locations spanning 3 distinct geographic areas - top geographies include California, Arizona, Colorado.
Frequently Asked Questions
What is clinical trial NCT05407636 about?
NCT05407636 is a clinical study titled "Pivotal 2 Study of RGX-314 Gene Therapy in Participants With nAMD". ABBV-RGX-314 (also known as RGX-314) is being developed as a novel one-time gene therapy for the treatment of neovascular (wet) age-related macular degeneration (wet AMD). Wet AMD is characterized by loss of vision due to new, leaky blood vessel formation in the retina. Wet AMD is a significant caus...
What is the current status of trial NCT05407636?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 660 participants. The study started on 2022-01-13. Estimated completion is 2027-11.
What conditions does trial NCT05407636 study?
This clinical trial studies the following conditions: Wet Age-related Macular Degeneration, AMD, wAMD, nAMD, CNV.
What interventions are being tested in trial NCT05407636?
The interventions under investigation include: ABBV-RGX-314 Dose 1 (GENETIC), ABBV-RGX-314 Dose 2 (GENETIC), Aflibercept (EYLEA®) (BIOLOGICAL).
Who is sponsoring clinical trial NCT05407636?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05407636 being conducted?
This trial has 20 study locations across Arizona, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Wet Age-related Macular Degeneration
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer and Tabirafusp Tedromer Compared to Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD) - DAYBREAK
ACTIVE NOT RECRUITING · Phase 3
-
A 2-year Study of EYP-1901 in Subjects With Wet Age Related Macular Degeneration (wAMD) (LUGANO) Primary Efficacy Will be Determined at Week 56
ACTIVE NOT RECRUITING · Phase 3
-
A 2-year Study of EYP-1901 in Subjects With Wet Age Related Macular Degeneration (wAMD) (LUCIA) Primary Efficacy Will be Determined at Week 56
ACTIVE NOT RECRUITING · Phase 3
-
A Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared With Intravitreal Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD)
COMPLETED · Phase 3
-
Pivotal 1 Study of ABBV-RGX-314 (Also Known as RGX-314) Gene Therapy Administered Via Subretinal Delivery One Time in Participants With nAMD
RECRUITING · Phase 2
-
Long-term Study of ADVM-022 in Neovascular (Wet) AMD [OPTIC-EXT]
ACTIVE NOT RECRUITING
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.