Non-Interventional Long Term Follow-up Study of Participants Previously Enrolled in the RESTORE Study

Condition(s) studied

Investigational drug(s) / intervention(s)

Gene Therapy product-MCO-010: Safety evaluation to monitor long term effects of previously injected MCO-010 in RP patients

Study summary

This study will be conducted following Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. Eligible subjects will be consented to return for scheduled study visits for this study following their completion in study NTXMCO-002 (RESTORE). They will not receive a second treatment with MCO-010 (or a repeated sham injection) in this study

Eligibility

Primary outcome measure(s)

• Assessment of the long-term safety of previous treatment with a single intravitreal injection of MCO-010 — 156 weeks
  Delayed adverse events. Incidence, nature, and severity of selected adverse events (AEs); all serious adverse events (SAEs); all ocular AEs including intraocular inflammation graded through ocular exam; non-ocular AEs with a common terminology criteria for adverse events (CTCAE) grade of 3 or greater; AEs of special interest (AESIs) including new malignancies, new incidence or exacerbation of any pre-existing neurologic disorder or rheumatologic or other autoimmune disorder, new incidence of hematologic disorder or new infection regardless of suspected relatedness to treatment with MCO-010.

Trial sites (6)

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