Structural and Functional Characterization of Rare Ocular Diseases (RADIS)

February 28, 2022 updated by: Marc Biarnes Perez, Barcelona Macula Foundation
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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with a ROD affecting the posterior segment of the eye

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Barcelona Macula Foundation

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 Major Dates

Study Start (Actual)

November 24, 2021

Primary Completion (Anticipated)

November 24, 2024

Study Completion (Anticipated)

November 24, 2025

Study Registration Dates

First Submitted

February 17, 2022

First Submitted That Met QC Criteria

February 17, 2022

First Posted (Actual)

February 28, 2022

Study Record Updates

Last Update Posted (Actual)

March 15, 2022

Last Update Submitted That Met QC Criteria

February 28, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BarcelonaMaculaF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Retinitis Pigmentosa

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Rwanda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe