NCT01220804

Brief Summary

The purpose of this study is to identify alterations of the blood-retinal barrier (BRB) in diabetic retinas using a novel non-invasive approach based on the Fourier domain high-definition optical coherence tomograph (OCT).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 14, 2010

Completed
18 days until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

April 25, 2016

Status Verified

April 1, 2016

Enrollment Period

1.1 years

First QC Date

October 11, 2010

Last Update Submit

April 22, 2016

Conditions

Diabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

  • Optical reflectivity as measured by optical coherence tomography

    To analyse OCT reflectivity distribution between areas with and without fluorescein leakage in type 2 diabetic eyes. In previous studies our group found differences, when comparing the histograms of the optical reflectivity distribution, suggesting that the optical reflectivity, as measured by OCT, may change under BRB alterations

    14 months

Study Arms (2)

NPDR

Type 2 diabetic patients with nonproliferative diabetic retinopathy (NPDR)

Control Population

Healthy volunteers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Type 2 diabetic patients with nonproliferative diabetic retinopathy (NPDR) (study population) and healthy volunteers (control population).

You may qualify if:

  • Age over 18 years; type-2 diabetes; NPDR levels 10, 20 and 35/47 (ETDRS severity scale), and area of retinal leakage of at least 25% of the RLA map (macular area).

You may not qualify if:

  • Presence of media opacity; vitreous syneresis or posterior vitreous detachment, and; previous photocoagulation treatments or any type of intraocular surgery or intravitreal medications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AIBILI

Coimbra, 3000-548, Portugal

Location

Related Links

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2010

First Posted

October 14, 2010

Study Start

November 1, 2010

Primary Completion

December 1, 2011

Study Completion

March 1, 2013

Last Updated

April 25, 2016

Record last verified: 2016-04

Locations

PT(1)