ClinicalTrials.gg
RecruitingNCT05258032RADISUpdated Mar 15, 2022

Structural and Functional Characterization of Rare Ocular Diseases

An observational study in Retinitis Pigmentosa, Stargardt Disease 1 and Best Disease, sponsored by Barcelona Macula Foundation. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-15.

Sponsored by Barcelona Macula Foundation · Observational

From the registry’s dates

  • Primary completion was expected by Nov 2024, 1 year 11 months ago, but the record still lists the study as recruiting.
  • Started Nov 2021; still recruiting 4 years 11 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • 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
03

In context

Retinitis Pigmentosa

278 studies on the registry are indexed under Retinitis Pigmentosa; 72 are open to participants now.

This study's planned enrollment of 50 is close to the median of 52 across 87 observational studies indexed under Retinitis Pigmentosa.

Browse Retinitis Pigmentosa studies →

Lead sponsor

Barcelona Macula Foundation is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with a ROD affecting the posterior segment of the eye

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Change in best corrected visual acuity

    Change from baseline in BCVA

    Time frame: Year 2 as compared to baseline

Secondary outcomes

  1. Change in mean macular sensitivity

    Change from baseline in mean macular sensitivity on microperimetry

    Time frame: Year 2 as compared to baseline

  2. Change in retinal thickness

    Change from baseline in central subfield retinal thickness on OCT

    Time frame: Year 2 as compared to baseline

07

Study locations

1 of 1 sites recruiting
  • Institut de la màcula
    Barcelona, 08022, Spain
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 15, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05258032
Lead sponsor
Barcelona Macula Foundation
Responsible party
Marc Biarnes Perez (PhD, Barcelona Macula Foundation) — Principal investigator
First posted
Feb 28, 2022
Start date
Nov 24, 2021
Primary completion
Nov 24, 2024 (estimated)
Completion
Nov 24, 2025 (estimated)
Last update
Mar 15, 2022

Study contacts

Marc Biarnes, PhD
Contact
mbiarnes@barcelonamaculafound.org
+34935950155

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Discussion

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