NCT04945772CompletedPhase 2
Efficacy and Safety of MCO-010 Optogenetic Therapy in Adults With Retinitis Pigmentosa [RESTORE]
A Phase 2b Randomized, Double-Masked, Sham-Controlled, Study to Evaluate the Efficacy and Safety of Intravitreal Injection of MCO-010 Optogenetic Therapy in Adults With Retinitis Pigmentosa [RESTORE]
Source: ClinicalTrials.gov · Last updated 22 Mar 2024
Brief summary (registry, in English)
The purpose of the study is to evaluate the safety and efficacy of a single intravitreal injection of virally-carried Multi-Characteristic Opsin (MCO-010).
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 27 (actual)
- First submitted
- 15 Jun 2021
- Start date
- 13 Jul 2021
- Primary completion date
- 27 Feb 2023
- Lead sponsor
- Nanoscope Therapeutics Inc.
- Diseases
- Retinitis pigmentosa
- NCT number
- NCT04945772
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 27
- From 13 Jul 2021 to the primary completion date, 27 Feb 2023
- 6 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior participation in gene therapy program
- Having received retinal prothesis (such as ARGUS-II) or any gene or stem cell therapy (ocular or non-ocular).
Other illness
- Pre-existing conditions in the study eye such as glaucoma, diseases affecting the optic nerve causing significant visual field loss, active uveitis, corneal or lenticular opacities).
- Presence of any complicating systemic diseases such as malignancies whose treatment could affect central nervous system function.
- Active ocular inflammation or recurrent history of idiopathic or autoimmune associated uveitis.
Other
- Subjects are excluded from the study if any of the following criteria apply:
Who the study is looking for
- Age ≥ 18 years
- Able to comprehend and give informed consent.
- Confirmed diagnosis of Advanced Retinitis Pigmentosa (RP) based on clinical examination, dilated fundus examination, and genetic testing.
- Best-Corrected (Freiburg) Visual Acuity worse than 1.9 LogMAR (Snellen equivalent 20/1600) in the study eye and no better than 1.6 LogMAR (Snellen equivalent 20/800) in the fellow eye during screening.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Arecibo | Puerto Rico | Unknown status |
| - Coordinator of this site? Confirm its status | Beverly Hills | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Fargo | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| - Coordinator of this site? Confirm its status | McAllen | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Pensacola | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.