Structural and Functional Characterization of Rare Ocular Diseases

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05258032

Acronym

RADIS

Enrollment

Registered

2022-02-28

Start date

2021-11-24

Completion date

2025-11-24

Last updated

2022-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change in best corrected visual acuity	Year 2 as compared to baseline	Change from baseline in BCVA

Secondary

Measure	Time frame	Description
Change in mean macular sensitivity	Year 2 as compared to baseline	Change from baseline in mean macular sensitivity on microperimetry
Change in retinal thickness	Year 2 as compared to baseline	Change from baseline in central subfield retinal thickness on OCT

Countries

Spain

Contacts

Primary ContactMarc Biarnes, PhD

mbiarnes@barcelonamaculafound.org+34935950155

Outcome results