Structural and Functional Characterization of Rare Ocular Diseases

Retinitis Pigmentosa Clinical Trial

— RADIS  

Official title:

Structural and Functional Characterization of Rare Ocular Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05258032
• Other study ID #: BarcelonaMaculaF
• Status: Recruiting
• Start date: November 24, 2021
• Est. completion date: November 24, 2025

Study information

• Verified date: February 2022
• Source: Barcelona Macula Foundation
• Contact: Marc Biarnes, PhD
• Phone: +34935950155
• Email: mbiarnes[@]barcelonamaculafound.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Rare ocular diseases (ROD) are a heterogeneous group of ocular diseases that affect very few people and, generally, for which no tretament is available. An important subgroup of these diseases are inherited retinal degenerations. In this study we focus on understanding the natural history of different ROD that affect the posterior segment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 24, 2025
• Est. primary completion date: November 24, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female 18 years or older with a diagnosis of a ROD affecting the posterior segment

• Patients able to undergo all required ophthalmic exams

• Patients able and willing to sign an informed consent

Exclusion Criteria:

• Patients with other concomitant posterior segment disorders

• Patients taking drugs known to affect the retina and/or optic nerve

• Patients that underwent an intraocular surgery (aside from phacoemulsification with intraocular lens implantation), corneal or glaucoma surgery

• Patients who have participated in the past 12 months or that are currently participating in clinical trials for an ocular disease

Related Conditions & MeSH terms

• Best Disease
• Choroideremia
• Pattern Dystrophy of Macula
• Retinitis
• Retinitis Pigmentosa
• Stargardt Disease
• Stargardt Disease 1
• Vitelliform Macular Dystrophy

Locations

Country	Name	City	State
Spain	Institut de la màcula	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Barcelona Macula Foundation

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in best corrected visual acuity	Change from baseline in BCVA	Year 2 as compared to baseline
Secondary	Change in mean macular sensitivity	Change from baseline in mean macular sensitivity on microperimetry	Year 2 as compared to baseline
Secondary	Change in retinal thickness	Change from baseline in central subfield retinal thickness on OCT	Year 2 as compared to baseline