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NCT06162585 · ClinicalTrials.gov registry record
Non-Interventional Long Term Follow-up Study of Participants Previously Enrolled in the RESTORE Study
A clinical trial of Retinitis Pigmentosa and Eye Diseases, sponsored by Nanoscope Therapeutics.
- Active
- Registry status
- 18
- Enrollment target
- 6
- Study locations
NCT06162585: Active study of Retinitis Pigmentosa and Eye Diseases, sponsored by Nanoscope Therapeutics.
NCT06162585 is a study of Retinitis Pigmentosa and Eye Diseases that is active but no longer recruiting, run by Nanoscope Therapeutics. The registered enrollment target is 18 participants, below the 261-participant average among 37 other Retinitis Pigmentosa trials with a reported enrollment target (93% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06162585, a study of Retinitis Pigmentosa and Eye Diseases, is active but no longer recruiting, sponsored by Nanoscope Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- 18 participants
- Enrollment target
- 6
- Study locations
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
Primary Outcome
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 hem
Conditions Studied
Interventions
- BIOLOGICAL Gene Therapy product-MCO-010
Study Locations (6)
Texas
- Nanoscope Clinical Site - Houston
- Nanoscope Clinical Site - McAllen
California
- Nanoscope Clinical Site - Beverly Hills
Florida
- Nanoscope Clinical Site - Pensacola
North Dakota
- Nanoscope Clinical Site - Fargo
Other
- Nanoscope Clinical Site - Arecibo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2023-12-08 |
| Est. Completion | 2027-09 |
What the registry record for NCT06162585 still lists
NCT06162585 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 261-participant average among 37 other Retinitis Pigmentosa trials with a reported enrollment target (93% lower).
The record links to 7 conditions, with Retinitis Pigmentosa appearing as the primary indexed condition, and to 1 intervention - of which Gene Therapy product-MCO-010 is the first listed.
NCT06162585 lists 6 locations in 5 states (Texas, California, Florida).
Frequently Asked Questions
What is clinical trial NCT06162585 about?
NCT06162585 is a clinical study titled "Non-Interventional Long Term Follow-up Study of Participants Previously Enrolled in the RESTORE Study". 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 ...
What is the current status of trial NCT06162585?
This trial is currently active not recruiting. The enrollment target is 18 participants. The study started on 2023-12-08. Estimated completion is 2027-09.
What conditions does trial NCT06162585 study?
This clinical trial studies the following conditions: Retinitis Pigmentosa, Eye Diseases, Retinal Degeneration, Eye Diseases, Hereditary, Retinal Dystrophies.
What interventions are being tested in trial NCT06162585?
The interventions under investigation include: Gene Therapy product-MCO-010 (BIOLOGICAL).
Who is sponsoring clinical trial NCT06162585?
This trial is sponsored by Nanoscope Therapeutics, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06162585 being conducted?
This trial has 6 study locations across California, Florida, North Dakota, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06162585's enrollment target sits among peer trials
18 28th of 37 higher than 10 of 37 other Retinitis Pigmentosa trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Retinitis Pigmentosa trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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