Structural and Functional Characterization of Rare Ocular Diseases

NCT05258032 | Unknown

• 1 other identifier: BarcelonaMaculaF
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Retinitis Pigmentosa; Stargardt Disease 1; Best Disease; Pattern Dystrophy of Macula; Choroideremia

Keywords

Retinitis pigmentosa; Stargardt's disease 1; Best disease; Pattern Dystrophy of Macula; Choroideremia

Outcome Measures

Primary Outcomes (1)

• Change in best corrected visual acuity

  Change from baseline in BCVA

  Year 2 as compared to baseline

Secondary Outcomes (2)

• Change in mean macular sensitivity

  Year 2 as compared to baseline

• Change in retinal thickness

  Year 2 as compared to baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a ROD affecting the posterior segment of the eye

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Barcelona Macula Foundation: lead

Study Sites (1)

Institut de la màcula

Barcelona, 08022, Spain

RECRUITING

MeSH Terms

Conditions

Retinitis Pigmentosa; Stargardt Disease; Vitelliform Macular Dystrophy; Choroideremia

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Retinal Dystrophies; Retinal Degeneration; Retinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Macular Degeneration; Choroid Diseases; Uveal Diseases; Genetic Diseases, X-Linked

Central Study Contacts

Marc Biarnes, PhD

CONTACT

+34935950155; mbiarnes@barcelonamaculafound.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: February 17, 2022
• First Posted: February 28, 2022
• Study Start: November 24, 2021
• Primary Completion: November 24, 2024
• Study Completion: November 24, 2025
• Last Updated: March 15, 2022

Record last verified: 2022-02

Locations

ES (1)