Retinitis PigmentosaRADISNCT05258032
Structural and Functional Characterization of Rare Ocular Diseases
An observational study of Retinitis Pigmentosa and Stargardt Disease 1, run by Barcelona Macula Foundation at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinitis Pigmentosa, Stargardt Disease 1, Best Disease
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 24 Nov 2021to 24 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a ROD affecting the posterior segment of the eye
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Institut de la màcula
Barcelona, 08022
Marc Biarnes, PhD, +34935950155, mbiarnes@barcelonamaculafound.org
About this study
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
- Medical subject headings
- Retinitis Pigmentosa, Stargardt Disease, Vitelliform Macular Dystrophy, Choroideremia
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in best corrected visual acuity
Change from baseline in BCVA
Measured: Year 2 as compared to baseline
Secondary outcomes (2)
Change in mean macular sensitivity
Change from baseline in mean macular sensitivity on microperimetry
Measured: Year 2 as compared to baseline
Change in retinal thickness
Change from baseline in central subfield retinal thickness on OCT
Measured: Year 2 as compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start24 Nov 2021
- Primary completion24 Nov 2024 (estimated)
- Study completion24 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinitis PigmentosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barcelona Macula Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc Biarnes Perez, Barcelona Macula Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05258032
- Sponsor's protocol ID
- BarcelonaMaculaF
- Acronym
- RADIS
- Status last verified
- Feb 2022
- First submitted
- 17 Feb 2022
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structural and Functional Characterization of Rare Ocular Diseases
- ClinicalTrials.gov ID
- NCT05258032
- Acronym / sponsor ID
- RADIS / BarcelonaMaculaF
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Barcelona Macula FoundationUniversity, hospital or other
- Study start
- 24 Nov 2021 (actual)
- Primary completion
- 24 Nov 2024 (estimated)
- Study completion
- 24 Nov 2025 (estimated)
- First posted
- 28 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a ROD affecting the posterior segment of the eye
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in best corrected visual acuity
Time frame: Year 2 as compared to baseline
Change from baseline in BCVA
2 secondary outcomes
Change in mean macular sensitivity
Time frame: Year 2 as compared to baseline
Change in retinal thickness
Time frame: Year 2 as compared to baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinitis Pigmentosa and Stargardt Disease 1, run by Barcelona Macula Foundation at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marc Biarnes, PhD (+34935950155, mbiarnes@barcelonamaculafound.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in best corrected visual acuity (time frame: Year 2 as compared to baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2022.