Efficacy and Safety of MCO-010 Optogenetic Therapy in Adults With Retinitis Pigmentosa [RESTORE]

Completed · Phase 2 · Has a placebo group

Conditions studied: Retinitis Pigmentosa, Retinitis, Retinal Diseases, Eye Diseases, Eye Diseases, Hereditary, Retinal Dystrophies, Retinal Degeneration

In brief

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).

Key facts

Study ID

NCT04945772

Run by

Nanoscope Therapeutics Inc.

People needed

27

Starts

2021-07-13

Expected to finish

2024-01-18

Last updated by the study team

2024-03-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Subjects are excluded from the study if any of the following criteria apply:
• Prior participation in gene therapy program
• 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.
• Having received retinal prothesis (such as ARGUS-II) or any gene or stem cell therapy (ocular or non-ocular).

Where it is running

• Nanoscope Clinical Site — Beverly Hills, California, United States
• Nanoscope Clinical Site — Pensacola, Florida, United States
• Nanoscope Clinical Site — Fargo, North Dakota, United States
• Nanoscope Clinical Site — Houston, Texas, United States
• Nanoscope Clinical Site — McAllen, Texas, United States
• Nanoscope Clinical Site — Arecibo, Puerto Rico

Full record on ClinicalTrials.gov

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