Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Biomarkers of Diabetic Retinopathy Progression (C-Tracer)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01607190
Recruitment Status : Completed
First Posted : May 30, 2012
Last Update Posted : July 19, 2018
Sponsor:
Information provided by (Responsible Party):
Association for Innovation and Biomedical Research on Light and Image

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to validate a predictive model of diabetic retinopathy progression in patients with diabetes mellitus type 2 patients to clinically significant macular edema (CSME) needing treatment either photocoagulation or intravitreal injections (ITV) using non-invasive techniques.

Condition or disease
Type 2 Diabetes Mellitus Mild Nonproliferative Diabetic Retinopathy

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Biomarkers of Diabetic Retinopathy Progression.
Study Start Date : November 2012
Actual Primary Completion Date : April 2016
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
Patients with diabetic retinopathy.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. CSME needing treatment either photocoagulation or ITV. [ Time Frame: Months 0, 6, 12 and 24. ]

Secondary Outcome Measures :
  1. Best corrected visual acuity. [ Time Frame: Months 0, 6, 12 and 24. ]
  2. Vision loss of at least 2 lines documented in ETDRS charts [ Time Frame: Months 0, 6, 12 and 24. ]
  3. Central retinal thickness [ Time Frame: Months 0, 6, 12 and 24. ]
  4. Microaneurysm(MA) activity (number of MA, MA formation and MA disappearance rates and MA turnover) [ Time Frame: Months 0, 6, 12 and 24. ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   35 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with type 2 diabetes mellitus and mild nonproliferative diabetic retinopathy
Criteria

Inclusion Criteria:

  • Type 2 diabetes mellitus
  • Age over 35 years-old
  • Non-proliferative diabetic retinopathy (Levels 20 to 35, according the ETDRS criteria)
  • Best Corrected Visual Acuity > 20/25 on the ETDRS chart
  • Informed Consent

Exclusion Criteria:

  • Previous laser therapy
  • Other retinal vascular disease
  • Glaucoma
  • Recent intraocular surgery (in the last 6 months)
  • Inadequate ocular media and/ or pupil dilatation that do not permit good quality fundus photography (e.g. cataract)
  • HbA1C > 11 % at the Screening
  • Subject that has a condition or that is in a situation which may put him/her at significant risk, may confound the study results or may interfere significantly with his/ her participation in the study.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01607190


Locations
Layout table for location information
India
LV Prasad Eye Institute
Hyderabad, Andhra Pradesh, India, 500 034
Portugal
AIBILI- Association for Biomedical Research and Inovation on Light and Image.
Coimbra, Portugal, 3000-548
Sponsors and Collaborators
Association for Innovation and Biomedical Research on Light and Image
Investigators
Layout table for investigator information
Study Chair: José Cunha-Vaz, MD, PhD Association for Innovation and Biomedical Research on Light and Image
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Association for Innovation and Biomedical Research on Light and Image
ClinicalTrials.gov Identifier: NCT01607190    
Other Study ID Numbers: 4C-2012-02
First Posted: May 30, 2012    Key Record Dates
Last Update Posted: July 19, 2018
Last Verified: July 2018
Keywords provided by Association for Innovation and Biomedical Research on Light and Image:
type 2 diabetes mellitus
nonproliferative diabetic retinopathy
Additional relevant MeSH terms:
Layout table for MeSH terms
Retinal Diseases
Diabetic Retinopathy
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications