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

NCT06162585 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 18

Last updated 2025-03-24

No results posted yet for this 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

Conditions

Interventions

BIOLOGICAL

Gene Therapy product-MCO-010

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

Sponsors & Collaborators

  • Nanoscope Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Samuel Barone, MD · Nanoscope Therapeutics Inc.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-08
Primary Completion
2027-07-31
Completion
2027-09-30
FDA Drug
Yes

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06162585 on ClinicalTrials.gov