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Observation of Participants exposed 1.2E11gc/eye of MCO-010 for Retinitis Pigmentosa (REMAIN Trial)

N/A

Waitlist Available

Research Sponsored by Nanoscope Therapeutics Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 156 weeks

Awards & highlights

No Placebo-Only Group

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

Eligible Conditions

Retinitis Pigmentosa
Retinal Dystrophy
Retinal Disease
Retinal Degeneration
None
Fungal Retinitis
Herpes simplex retinopathy
Eye Diseases
Eye Conditions
Retinitis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 156 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~156 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 156 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Assessment of the long-term safety of previous treatment with a single intravitreal injection of MCO-010

Secondary study objectives

Evaluation of long-term effects on navigation/mobility at multiple light levels of previous treatment with a single intravitreal injection with MCO-010

Evaluation of long-term effects on shape discrimination at multiple light levels of previous treatment with a single intravitreal injection with MCO-010

Evaluation of long-term effects on visual acuity of previous treatment with a single intravitreal injection of MCO-010

+1 more

Other study objectives

Assessment of the long-term pharmacokinetic (PK) and pharmacodynamic (PD) impact of previous treatment with MCO-010 on gene reporter expression

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Observation of Participants exposed to 0.9E11gc/eye of MCO-010Experimental Treatment1 Intervention

This is a long-term follow-up observational study of participants who previously received 0.9E11gc/eye of MCO-010 No investigational product will be administered in this study.

Group II: Observation of Participants exposed 1.2E11gc/eye of MCO-010Experimental Treatment1 Intervention

This is a long-term follow-up observational study of participants who previously received 1.2E11gc/eye of MCO-010. No investigational product will be administered in this study.

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