Long-term Follow-up Study in Subjects Who Received Voretigene Neparvovec-rzyl (AAV2-hRPE65v2)

Plain-language summary

This study follows the long-term safety and outcomes of patients who previously received the retinal gene therapy Voretigene Neparvovec-rzyl (AAV2-hRPE65v2). It includes patients who took part in prior subretinal AAV2-hRPE65v2 gene therapy studies. It is a non-phase follow-up study that is active, not recruiting.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Active, not recruiting

Sponsor

Genentech, Inc.

Intervention

AAV2-hRPE65v2

Start date

6/1/2015

Estimated completion

1/1/2030

Related genes

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

1\. Subjects who participated in prior subretinal AAV2-hRPE65v2 gene therapy clinical studies

Exclusion Criteria:

1. Subjects who will not consent for study.
2. Subjects who the investigators believe are not capable of performing study assessments