Validation of a New Methodology for Mapping the Human Blo... | NCT00759044

Studies
Validation of a New Methodology for Mapping the Human Blood-Retinal Barrier Function

NCT00759044

Sponsor

Association for Innovation and Biomedical Research on Light and Image

Status

Completed

Last Update Posted

Oct 15, 2015Estimated

Enrollment

90Actual

Phase

Not provided

Conditions

Age-Related Maculopathy
Diabetic Macular Edema

Interventions

Not provided

Countries

Portugal

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

Oct 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2008

Primary Completion Date

Oct 2010Actual

Completion Date

Oct 2010Actual

First Submitted Date

Sep 24, 2008

First Submission Date that Met QC Criteria

Sep 24, 2008

First Posted Date

Sep 25, 2008Estimated

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

Oct 13, 2015

Last Update Posted Date

Oct 15, 2015Estimated

Description Module

Brief Summary

To validate a new methodology, named Retinal Leakage Analysis (RLA), for mapping the human Blood-Retinal Barrier (BRB) function, in the clinical practice.

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

Not provided

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

90Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AMD		Patients diagnosed with AMD
DME		Patients diagnosed with DME

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blood-Retinal Barrier (BRB) function measured by Retinal Leakage Analysis (RLA).

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients diagnosed with AMD, or
Patients diagnosed with DME
Age over 18 years
Inform consent

Exclusion Criteria:

Cataract or other eye disease that may interfere with fundus examinations
Glaucoma
Dilatation of the pupil < 5 mm

Accepts Healthy Volunteers

Yes

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 AMD or DME followed regularly by their ophthalmologist at the AIBILI Clinical Trial Center will be asked to perform additional optical examinations as a continuation of the routine fluorescein angiographies (FA).

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
José G Cunha-Vaz, Prof.	Association for Innovation and Biomedical Research on Light and Image	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AIBILI Clinical Trial Center		Coimbra	Coimbra District	3000-548	Portugal

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15651569	Background	Bernardes R, Dias J, Cunha-Vaz J. Mapping the human blood-retinal barrier function. IEEE Trans Biomed Eng. 2005 Jan;52(1):106-16. doi: 10.1109/TBME.2004.839801.

ID	Term
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases