NCT00763802

Brief Summary

This project aims to validate a predictive model of diabetic retinopathy progression to clinically significant macular edema (CSME) needing photocoagulation and/or vision loss. The Coimbra Predictive Model (CPM), based on retinal thickness, microaneurysms number, HbA1C and LDL levels, established on a set of 52 diabetic patients, will be tested on a population of 400 patients/eyes to be enrolled into the study. These patients will perform 2 visits at 6-month interval (V0 and V6) to classify each patient into one of the 3 previously established phenotypes. Two years after (V24) patients will be reexamined. The occurrence of end-points, achieved by the patients, are expected to validate our predictive model.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2007

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

Study Start

First participant enrolled

September 1, 2007

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 30, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 1, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

April 7, 2014

Status Verified

April 1, 2014

Enrollment Period

3 years

First QC Date

September 30, 2008

Last Update Submit

April 4, 2014

Conditions

Diabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

  • CSME needing Photocoagulation

    24 months

Secondary Outcomes (1)

  • Vision Loss

    24 months

Study Arms (1)

MNPDR

Type 2 diabetic patients with Mild non-prolipherative retinopathy.

Eligibility Criteria

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

Type 2 diabetic patients with Mild non-prolipherative retinopathy fulfilling the inclusion criterion.

You may qualify if:

  • Diabetes type 2 according to 1985 WHO criteria.
  • Age between 35 and 75 years.
  • Mild non-prolipherative retinopathy (based on ETDRS criteria)
  • Best Corrected Visual acuity \>20 /25
  • Refraction with a spherical equivalent less than 5 Dp.
  • Inform consent

You may not qualify if:

  • Cataract or other eye disease that may interfere with fundus examinations
  • Glaucoma
  • Vitreous syneresis or posterior vitreous detachment
  • Other retinal vascular disease
  • Recent intraocular surgery
  • Previous laser therapy
  • Dilatation of the pupil \< 5 mm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AIBILI

Coimbra, Coimbra District, 3000-548, Portugal

Location

Related Publications (10)

  • Cunha-Vaz J, Bernardes R. Nonproliferative retinopathy in diabetes type 2. Initial stages and characterization of phenotypes. Prog Retin Eye Res. 2005 May;24(3):355-77. doi: 10.1016/j.preteyeres.2004.07.004. Epub 2004 Dec 16.

    PMID: 15708833BACKGROUND

  • Lobo CL, Bernardes RC, Figueira JP, de Abreu JR, Cunha-Vaz JG. Three-year follow-up study of blood-retinal barrier and retinal thickness alterations in patients with type 2 diabetes mellitus and mild nonproliferative diabetic retinopathy. Arch Ophthalmol. 2004 Feb;122(2):211-7. doi: 10.1001/archopht.122.2.211.

    PMID: 14769598BACKGROUND

  • Hayreh SS. Diabetic papillopathy and nonarteritic anterior ischemic optic neuropathy. Surv Ophthalmol. 2002 Nov-Dec;47(6):600-2; author reply 602. doi: 10.1016/s0039-6257(02)00358-2. No abstract available.

    PMID: 12504747BACKGROUND

  • Pires I, Bernardes RC, Lobo CL, Soares MA, Cunha-Vaz JG. Retinal thickness in eyes with mild nonproliferative retinopathy in patients with type 2 diabetes mellitus: comparison of measurements obtained by retinal thickness analysis and optical coherence tomography. Arch Ophthalmol. 2002 Oct;120(10):1301-6. doi: 10.1001/archopht.120.10.1301.

    PMID: 12365908BACKGROUND

  • 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, Ribeiro L, Lobo C. Phenotypes and biomarkers of diabetic retinopathy. Prog Retin Eye Res. 2014 Jul;41:90-111. doi: 10.1016/j.preteyeres.2014.03.003. Epub 2014 Mar 26.

    PMID: 24680929DERIVED

  • Pires I, Santos AR, Nunes S, Lobo C, Cunha-Vaz J. Subclinical macular edema as a predictor of progression to clinically significant macular edema in type 2 diabetes. Ophthalmologica. 2013;230(4):201-6. doi: 10.1159/000354550. Epub 2013 Sep 25.

    PMID: 24080704DERIVED

  • Nunes S, Ribeiro L, Lobo C, Cunha-Vaz J. Three different phenotypes of mild nonproliferative diabetic retinopathy with different risks for development of clinically significant macular edema. Invest Ophthalmol Vis Sci. 2013 Jul 10;54(7):4595-604. doi: 10.1167/iovs.13-11895.

    PMID: 23745006DERIVED

  • Pires I, Santos AR, Nunes S, Lobo C. Macular thickness measured by stratus optical coherence tomography in patients with diabetes type 2 and mild nonproliferative retinopathy without clinical evidence of macular edema. Ophthalmologica. 2013;229(4):181-6. doi: 10.1159/000350593. Epub 2013 Apr 24.

    PMID: 23614970DERIVED

  • Ribeiro ML, Nunes SG, Cunha-Vaz JG. Microaneurysm turnover at the macula predicts risk of development of clinically significant macular edema in persons with mild nonproliferative diabetic retinopathy. Diabetes Care. 2013 May;36(5):1254-9. doi: 10.2337/dc12-1491. Epub 2012 Nov 30.

    PMID: 23204247DERIVED

Related Links

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • José G Cunha-Vaz, MD, PhD

    Association for Innovation and Biomedical Research on Light and Image

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 30, 2008

First Posted

October 1, 2008

Study Start

September 1, 2007

Primary Completion

September 1, 2010

Study Completion

May 1, 2011

Last Updated

April 7, 2014

Record last verified: 2014-04

Locations

PT(1)