Structural and Functional Characterization of Rare Ocular... | NCT05258032

Studies
Structural and Functional Characterization of Rare Ocular Diseases

NCT05258032

Sponsor

Barcelona Macula Foundation

Status

Unknown status

Last Update Posted

Mar 15, 2022Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

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

Interventions

Not provided

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 24, 2021Actual

Primary Completion Date

Nov 24, 2024Estimated

Completion Date

Nov 24, 2025Estimated

First Submitted Date

Feb 17, 2022

First Submission Date that Met QC Criteria

Feb 17, 2022

First Posted Date

Feb 28, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 28, 2022

Last Update Posted Date

Mar 15, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with a ROD affecting the posterior segment of the eye

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Marc Biarnes, PhD	Contact	+34935950155		mbiarnes@barcelonamaculafound.org

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institut de la màcula	Recruiting	Barcelona		08022	Spain

Condition Browse Module

MeSH Terms

ID	Term
D012174	Retinitis Pigmentosa
D000080362	Stargardt Disease
D057826	Vitelliform Macular Dystrophy
D015794	Choroideremia

Ancestor Terms

ID	Term
D015785	Eye Diseases, Hereditary
D005128	Eye Diseases
D058499	Retinal Dystrophies
D012162	Retinal Degeneration

Browse Leaves

Not provided

Browse Branches

Not provided