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NCT Number: NCT05921162

A Long-Term Follow-Up Study in Subjects Who Received vMCO-I Administered Via Intravitreal Injection

This study "A Long-Term Follow-Up Study in Subjects Who Received an Adeno-Associated Viral Vector Serotype 2 Containing the Multi-Characteristic Opsin Gene (vMCO-I) Administered Via Intravitreal Injection" is an observational study and will be conducted following Good Clinical Practice (GCP)- International Conference on Harmonization (ICH) guidelines. Eligible subjects satisfying all inclusion and none of the exclusion criteria will be enrolled. All subject who completed the parent clinical study (NSCT/CT/18/01) will undergo safety and efficacy assessments up to 5 years post study drug injection

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Key information

Conditions

Retinitis Pigmentosa Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Retinal Degeneration Retinal Disease Retinal Diseases Retinal Dystrophies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

JPM Rotary Club of Cuttack Eye Hospital and Research Institute

Cuttack, Odisha, 753014, India

About this study

The observational study population comprises of individuals who received an Adeno-Associated Viral Vector Serotype 2 Containing the Multi-Characteristic Opsin Gene (vMCO-I) Administered Via Intravitreal Injection in a parent study.

Enrolled subjects will undergo safety and efficacy assessments for up to 5 years from the vMCO-I administration. At the visits, subjects will have safety and efficacy evaluations. Subjects will have a final visit at 60 months post study drug administration.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The subject population includes subjects who received an Adeno-Associated Viral Vector Serotype 2 Containing the Multi-Characteristic Opsin Gene (vMCO-I), administered via intravitreal injection in a parent study.

Exclusion criteria

  • Subjects who will not consent for study.

Treatment and study plan

Gene Therapy product:vMCO-I

Biological

Safety evaluation to monitor long term effects of previously injected vMCO-I in RP patients

Primary outcomes

  1. Assessment of the long-term safety profile of a single intravitreal injection of vMCO-I

    Time frame: 20 Months

    Assessments of Incidences, nature, and severity of treatment emergent adverse events (TEAEs), Serious Adverse Events (SAEs); intraocular inflammation graded through ocular exam; intraocular pressure and retinal anatomy

  2. Evaluation of the long-term efficacy of a single intravitreal injection of Multi-Characteristic Opsin (vMCO-I)

    Time frame: 20 Months

    Assessment of treatment effect with the change from baseline in Freiburg Visual Acuity (quantitative LogMAR score)

Secondary outcomes

  1. Assessment of the effect of vMCO-I on functional vision outcomes

    Time frame: 20 Months

    Assessment of the treatment effect on the quality of Life with changes from baseline in activities of daily living using the National Eye Institute (NEI) Visual Function Questionnaire-25

  2. Assessment of the durability of vMCO-I induced gene reporter expression

    Time frame: 20 Months

    Assessment of PK parameters including the Change in fundus fluorescence intensity of reporter (mCherry)

Sponsors and collaborators

Lead sponsor

Nanoscope Therapeutics Inc.

Industry

Registry information

Official study title

A Long-Term Follow-Up Study in Subjects Who Received an Adeno-Associated Viral Vector Serotype 2 Containing the Multi-Characteristic Opsin Gene (vMCO-I) Administered Via Intravitreal Injection

Acronym: EXTEND

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 27, 2023
Registry last updated
Mar 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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