This is an extension study providing long-term follow-up of a gene therapy called Engensis (VM202) used for painful diabetic neuropathy. Patients who had previously been enrolled in the VMDN-003 study and received Engensis (VM202) or placebo could take part. It was conducted in Phase 3 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: 1. Were randomized and dosed in the VMDN-003 study 2. Received all intramuscular injections of study drug on Days 0, 14, 90, and 104 in the VMDN-003 study 3. Were in follow-up for the VMDN-003 study or had completed Day 270 within the last 90 days prior to signing consent Exclusion Criteria: 1. Were using an investigational drug or treatment 2. Were unable or unwilling to give informed consent