Phenotyping Diabetic Retinopathy

NCT ID: NCT00840541

Last Updated: 2014-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Study Completion Date

2012-01-31

Brief Summary

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The purpose of this study is to validate and characterize phenotypes of diabetic retinopathy (DR) progression based on available clinical data (demographic, systemic and ophthalmic data).

Detailed Description

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This study aims to validate and characterize phenotypes of diabetic retinopathy (DR) progression using ophthalmic and systemic data from type-2 diabetic subjects followed at the AIBILI Clinical Trial Center in the last 10 years.

Macular Edema (ME) development during the study period, mainly Clinically Significant ME (CSME) needing treatment, will be the primary indicator for DR progression. CSME will be considered as the primary end-point and will be used to identify phenotypes (and risk markers) of DR progression.

Conditions

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Diabetic Retinopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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DR

Type-2 diabetic subjects diagnosed with diabetic retinopathy (DR).

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of DR.
* Females or Males;
* Age over 18 years;
* Signed Informed Consent;
* Previous follow-up with regular systemic and ophthalmic assessments.

Exclusion Criteria

* Cataract or other eye disease that may interfere with fundus examinations;
* Vitreous syneresis or posterior vitreous detachment;
* Dilatation of the pupil \< 5 mm.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Association for Innovation and Biomedical Research on Light and Image

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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José Cunha-Vaz, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Association for Innovation and Biomedical Research on Light and Image

Locations

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AIBILI - Clinical Trial Center

Coimbra, Coimbra District, Portugal

Site Status

Countries

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Portugal

References

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Cunha-Vaz J. Characterization and relevance of different diabetic retinopathy phenotypes. Dev Ophthalmol. 2007;39:13-30. doi: 10.1159/000098497.

Reference Type BACKGROUND
PMID: 17245076 (View on PubMed)

Related Links

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Other Identifiers

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CNTM018A

Identifier Type: -

Identifier Source: org_study_id

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