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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

Tracking Information
First Submitted Date May 23, 2012
First Posted Date May 30, 2012
Last Update Posted Date July 19, 2018
Study Start Date November 2012
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 24, 2012)
CSME needing treatment either photocoagulation or ITV. [ Time Frame: Months 0, 6, 12 and 24. ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01607190 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 24, 2012)
  • Best corrected visual acuity. [ Time Frame: Months 0, 6, 12 and 24. ]
  • Vision loss of at least 2 lines documented in ETDRS charts [ Time Frame: Months 0, 6, 12 and 24. ]
  • Central retinal thickness [ Time Frame: Months 0, 6, 12 and 24. ]
  • Microaneurysm(MA) activity (number of MA, MA formation and MA disappearance rates and MA turnover) [ Time Frame: Months 0, 6, 12 and 24. ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Biomarkers of Diabetic Retinopathy Progression
Official Title Biomarkers of Diabetic Retinopathy Progression.
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with type 2 diabetes mellitus and mild nonproliferative diabetic retinopathy
Condition
  • Type 2 Diabetes Mellitus
  • Mild Nonproliferative Diabetic Retinopathy
Intervention Not Provided
Study Groups/Cohorts Patients with diabetic retinopathy.
Publications * Cunha-Vaz J, Ribeiro L, Costa M, Simó 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 24, 2012)
200
Original Estimated Enrollment Same as current
Actual Study Completion Date December 2017
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 35 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries India,   Portugal
Removed Location Countries  
 
Administrative Information
NCT Number NCT01607190
Other Study ID Numbers 4C-2012-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Association for Innovation and Biomedical Research on Light and Image
Study Sponsor Association for Innovation and Biomedical Research on Light and Image
Collaborators Not Provided
Investigators
Study Chair: José Cunha-Vaz, MD, PhD Association for Innovation and Biomedical Research on Light and Image
PRS Account Association for Innovation and Biomedical Research on Light and Image
Verification Date July 2018