Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

An Open Label Dose Escalation Clinical Trial to Evaluate the Safety and the Tolerability of GS010 (rAAV2/2-ND4) in Patients With Leber Hereditary Optic Neuropathy Due to Mutations in the Mitochondrial NADH Dehydrogenase 4 Gene

Next Previous
Trial Profile

An Open Label Dose Escalation Clinical Trial to Evaluate the Safety and the Tolerability of GS010 (rAAV2/2-ND4) in Patients With Leber Hereditary Optic Neuropathy Due to Mutations in the Mitochondrial NADH Dehydrogenase 4 Gene

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 16 Mar 2023

Price :
$35 *
Note:
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

  • Drugs Lenadogene nolparvovec (Primary)
  • Indications Leber's hereditary optic atrophy
  • Focus Adverse reactions; First in man
  • Acronyms REVEAL Study
  • Sponsors GenSight Biologics

Most Recent Events

  • 09 Mar 2023 According to a GenSight Biologics media release, company announced publication of a peer-reviewed article in American Journal of Ophthalmology on pooled safety analysis of lenadogene nolparvovec from five clinical studies (REVEAL, RESCUE, REVERSE, RESTORE and REFLECT).
  • 24 Jan 2022 According to a GenSight Biologics media release, the review of the European Marketing Authorisation Application for LUMEVOQ is ongoing, with the decision from the CHMP expected in Q4 2022.
  • 29 Jul 2021 According to a GenSight Biologics media release, Following a delay in manufacturing validation batches of LUMEVOQ as a consequence of the US Defense Production Act (DPA), The EU marketing authorization is expected in H1 2022.

You need to be a logged in or subscribed to view this content

Request demo (opens in a new window)
If your organization or you do not have a subscription, try one of the following: If your organization has a subscription, there are several access options, even while working remotely:
  • Working within your organization’s network
  • with username/password or try to via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days
Back to top