CompletedPhase 2

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

United States27 participantsStarted 2021-07-13

Plain-language summary

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).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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).

What they're measuring

Efficacy of a single intravitreal injection of Multi-Characteristic Opsin (MCO-010) as assessed by best corrected visual acuity.

Timeframe: Week 52

Trial details

NCT IDNCT04945772

SponsorNanoscope Therapeutics Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-02-27

View on ClinicalTrials.gov More Retinitis Pigmentosa trials