NCT01145599

Brief Summary

The purpose of this study is to identify eyes that show worsening and disease progression (progressor phenotypes).

Trial Health

80
On Track

Trial Health Score

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

Enrollment
374

participants targeted

Target at P75+ 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

June 15, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 16, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Last Updated

February 11, 2015

Status Verified

November 1, 2013

Enrollment Period

3.1 years

First QC Date

June 15, 2010

Last Update Submit

February 10, 2015

Conditions

Type 2 DiabetesNon Proliferative Diabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

  • Identify "progressors"

    To identify "progressors" in retinal vascular disease and central retinal edema, the following 2 biomarkers will be considered: the MA formation rate (biomarker for the progression of retinal vascular disease) and the presence of retinal thickening in the central subfield and/or the inner ring (biomarker for the presence of retinal edema).

    12 months

Secondary Outcomes (1)

  • Identify correlations between "progressors" and study outcomes.

    12 months

Study Arms (1)

Type-2 diabetes, NPDR

Type-2 diabetic patients with NPDR.

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Type-2 diabetes, NPDR

You may qualify if:

  • Diabetes type 2 according to 1985 WHO criteria
  • Age between 35 and 75 years
  • Mild non-proliferative diabetic retinopathy (levels 20 or 35, based on the ETDRS criteria) - 7 fields color fundus photography
  • Presence of at least 1 microaneurysm in the central 3000 micr. in diameter area (corresponding to 2 DA) - Field 2
  • Best Corrected Visual Acuity \>= 75 letters (\>= 20 /32)
  • Refraction with a spherical equivalent less than 5 Dp
  • Informed consent

You may not qualify if:

  • Cataract or other eye disease that may interfere with fundus examinations
  • Glaucoma
  • Any eye surgery within a period of 6-months
  • Other retinal vascular disease
  • Previous laser therapy
  • Dilatation of the pupil \< 5 mm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Clinical Trials- AIBILI - Association for Innovation and Biomedical Research on Light and Image

Coimbra, Coimbra District, 3030-548, Portugal

Location

Related Publications (5)

  • Cunha-Vaz J, Ribeiro L, Costa M, Simo R. Diabetic Retinopathy Phenotypes of Progression to Macular Edema: Pooled Analysis From Independent Longitudinal Studies of up to 2 Years' Duration. Invest Ophthalmol Vis Sci. 2017 May 1;58(6):BIO206-BIO210. doi: 10.1167/iovs.17-21780.

    PMID: 28785768DERIVED

  • Cunha-Vaz J, Santos T, Ribeiro L, Alves D, Marques I, Goldberg M. OCT-Leakage: A New Method to Identify and Locate Abnormal Fluid Accumulation in Diabetic Retinal Edema. Invest Ophthalmol Vis Sci. 2016 Dec 1;57(15):6776-6783. doi: 10.1167/iovs.16-19999.

    PMID: 27978559DERIVED

  • Ribeiro L, Bandello F, Tejerina AN, Vujosevic S, Varano M, Egan C, Sivaprasad S, Menon G, Massin P, Verbraak FD, Lund-Andersen H, Martinez JP, Jurgens I, Smets E, Coriat C, Wiedemann P, Agoas V, Querques G, Holz FG, Nunes S, Neves C, Cunha-Vaz J; Evicr Net Study Group. Characterization of Retinal Disease Progression in a 1-Year Longitudinal Study of Eyes With Mild Nonproliferative Retinopathy in Diabetes Type 2. Invest Ophthalmol Vis Sci. 2015 Aug;56(9):5698-705. doi: 10.1167/iovs.15-16708.

    PMID: 26322834DERIVED

  • Tejerina AN, Vujosevic S, Varano M, Egan C, Sivaprasad S, Menon G, Massin P, Verbraak FD, Lund-Andersen H, Martinez JP, Jurgens I, Smets E, Coriat C, Wiedemann P, Agoas V, Querques G, Holz FG, Nunes S, Alves D, Neves C, Santos T, Ribeiro L, Bandello F, Cunha-Vaz J; for EVICR.net. One-year progression of diabetic subclinical macular edema in eyes with mild nonproliferative diabetic retinopathy: location of the increase in retinal thickness. Ophthalmic Res. 2015;54(3):118-23. doi: 10.1159/000438793. Epub 2015 Aug 21.

    PMID: 26315560DERIVED

  • Bandello F, Tejerina AN, Vujosevic S, Varano M, Egan C, Sivaprasad S, Menon G, Massin P, Verbraak FD, Lund-Andersen H, Martinez JP, Jurgens I, Smets RM, Coriat C, Wiedemann P, Agoas V, Querques G, Holz FG, Nunes S, Alves D, Neves C, Santos T, Ribeiro L, Cunha-Vaz J; EVICR.net. Retinal layer location of increased retinal thickness in eyes with subclinical and clinical macular edema in diabetes type 2. Ophthalmic Res. 2015;54(3):112-7. doi: 10.1159/000438792. Epub 2015 Aug 21.

    PMID: 26315448DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • José Cunha-Vaz, MD PhD

    Association for Innovation and Biomedical Research on Light and Image

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2010

First Posted

June 16, 2010

Study Start

September 1, 2010

Primary Completion

October 1, 2013

Last Updated

February 11, 2015

Record last verified: 2013-11

Locations

PT(1)