A Patient Registry Study for Patients Treated With Voretigene Neparvovec in US
Public ClinicalTrials.gov record NCT03597399. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Post-Authorization, Multicenter, Longitudinal, Observational Safety Registry Study for Patients Treated With Voretigene Neparvovec in US
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The objective of this study is to collect long-term safety information (i.e., for 5 years after treatment) associated with voretigene neparvovec-rzyl (vector and/or transgene), its subretinal injection procedure, the concomitant use of corticosteroids, or a combination of these procedures and products. The enrollment period will last for two years from the first treatment following product approval (through 31March2020) and include a minimum of 40 patients.
Study identification
- NCT ID
- NCT03597399
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 87 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 12 Months and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 10, 2019 (Actual)
- Primary completion
- Jun 30, 2025 (Actual)
- Completion
- Jun 30, 2025 (Actual)
- Last update posted
- Sep 22, 2025
2019 – 2025
United States locations
- U.S. sites
- 10
- U.S. states
- 9
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's Hospital of Los Angeles | Los Angeles | California | 90027 | — |
| Bascom Palmer Eye Institute | Miami | Florida | 33136 | — |
| University of Iowa Hospitals & Clinics | Iowa City | Iowa | 52242 | — |
| Massachusetts Eye and Ear Institute | Boston | Massachusetts | 02114 | — |
| Kellogg Eye Center | Ann Arbor | Michigan | 48105 | — |
| Cincinnati Eye Institute | Cincinnati | Ohio | 45242 | — |
| Casey Eye Institute | Portland | Oregon | 97239 | — |
| Children's Hospital of Philadelphia (CHOP) | Philadelphia | Pennsylvania | 19104 | — |
| Scheie Eye Institute | Philadelphia | Pennsylvania | 19104 | — |
| Cullen Eye Institute | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03597399, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 22, 2025 · Synced Oct 24, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03597399 live on ClinicalTrials.gov.