ACTIVE_NOT_RECRUITING

A Prospective, Observational Study in Adults With Retinitis Pigmentosa (RP)

Conditions

Retinitis Pigmentosa Retinitis Pigmentosa. Natural history

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The natural history in individuals with severe retinitis pigmentosa (RP) is variable and there remains an unmet need to better understand disease progression in this population. The goal of this study is to determine which visual assessments individuals with RP and low visual acuity can reliably perform and to evaluate the annual decline of visual function in severe RP.

Official Title

A Prospective, Observational Study in Adults With Retinitis Pigmentosa (RP)

Quick Facts

Study Start:2024-10-03

Study Completion:2026-02-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06517940

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Subject is ≥ 18 years of age at the time of informed consent. * Subject has a clinical diagnosis of nonsyndromic retinitis pigmentosa. * Subject is willing to consent to genetic testing, if not already done. * Subject has BCVA in the worse eye between hand motion and 35 Early Treatment of Diabetic Retinopathy Study (ETDRS) letter score (approximately ≤ 20/200 Snellen equivalent), inclusive. * Subject has a central visual field diameter (ie, excluding temporal islands) of \< 20 degrees in the worse eye as measured with the V4e stimulus using kinetic perimetry.	* Subject has an eye disease or visual disorder other than retinitis pigmentosa that impairs visual function. * Subject has any other eye condition, which in the opinion of the Investigator, would preclude an accurate evaluation at any time during the study. * Subject has any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in the study. * Subject has received treatment with any nonapproved, experimental, or investigational therapy in either eye (systemic, topical, intravitreal) and/or received treatment in an interventional clinical trial for an eye disease or disorder within 90 days or 5 half-lives, whichever is longer, prior to Screening or anticipates the need to receive treatment in an interventional clinical trial during their participation in this study. * Subject has previously received cell therapy, gene augmentation therapy, genome editing therapy, or any subretinal administered therapy for an eye disease or disorder or anticipates the need for these therapies during their participation in this study. * Subject has previously received LUXTURNA (voretigene neparvovec-rzyl) or anticipates the need for this therapy during their participation in this study.

Inclusion Criteria

Exclusion Criteria

* Subject is ≥ 18 years of age at the time of informed consent.
* Subject has a clinical diagnosis of nonsyndromic retinitis pigmentosa.
* Subject is willing to consent to genetic testing, if not already done.
* Subject has BCVA in the worse eye between hand motion and 35 Early Treatment of Diabetic Retinopathy Study (ETDRS) letter score (approximately ≤ 20/200 Snellen equivalent), inclusive.
* Subject has a central visual field diameter (ie, excluding temporal islands) of \< 20 degrees in the worse eye as measured with the V4e stimulus using kinetic perimetry.

* Subject has an eye disease or visual disorder other than retinitis pigmentosa that impairs visual function.
* Subject has any other eye condition, which in the opinion of the Investigator, would preclude an accurate evaluation at any time during the study.
* Subject has any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in the study.
* Subject has received treatment with any nonapproved, experimental, or investigational therapy in either eye (systemic, topical, intravitreal) and/or received treatment in an interventional clinical trial for an eye disease or disorder within 90 days or 5 half-lives, whichever is longer, prior to Screening or anticipates the need to receive treatment in an interventional clinical trial during their participation in this study.
* Subject has previously received cell therapy, gene augmentation therapy, genome editing therapy, or any subretinal administered therapy for an eye disease or disorder or anticipates the need for these therapies during their participation in this study.
* Subject has previously received LUXTURNA (voretigene neparvovec-rzyl) or anticipates the need for this therapy during their participation in this study.

Contacts and Locations

Study Locations (Sites)

Mass Eye and Ear

Boston, Massachusetts, 02114

United States

Collaborators and Investigators

Sponsor: Sumitomo Pharma America, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-03

Study Completion Date2026-02-28

Study Record Updates

Study Start Date2024-10-03

Study Completion Date2026-02-28

Terms related to this study

Keywords Provided by Researchers

Retinitis Pigmentosa. Natural history

Additional Relevant MeSH Terms

Retinitis Pigmentosa