A Long-Term Follow-Up Study in Subjects Who Received vMCO-I Administered Via Intravitreal Injection

Condition(s) studied

Investigational drug(s) / intervention(s)

Gene Therapy product:vMCO-I: Safety evaluation to monitor long term effects of previously injected vMCO-I in RP patients

Study summary

This study "A Long-Term Follow-Up Study in Subjects Who Received an Adeno-Associated Viral Vector Serotype 2 Containing the Multi-Characteristic Opsin Gene (vMCO-I) Administered Via Intravitreal Injection" is an observational study and will be conducted following Good Clinical Practice (GCP)- International Conference on Harmonization (ICH) guidelines. Eligible subjects satisfying all inclusion and none of the exclusion criteria will be enrolled. All subject who completed the parent clinical study (NSCT/CT/18/01) will undergo safety and efficacy assessments up to 5 years post study drug injection

Eligibility

Primary outcome measure(s)

• Assessment of the long-term safety profile of a single intravitreal injection of vMCO-I — 20 Months
  Assessments of Incidences, nature, and severity of treatment emergent adverse events (TEAEs), Serious Adverse Events (SAEs); intraocular inflammation graded through ocular exam; intraocular pressure and retinal anatomy
• Evaluation of the long-term efficacy of a single intravitreal injection of Multi-Characteristic Opsin (vMCO-I) — 20 Months
  Assessment of treatment effect with the change from baseline in Freiburg Visual Acuity (quantitative LogMAR score)

Trial sites (1)

Other trials for the same condition