Biomarkers of Diabetic Retinopathy Progression

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Association for Innovation and Biomedical Research on Light and Image
ClinicalTrials.gov Identifier:
NCT01607190
First received: May 23, 2012
Last updated: April 4, 2014
Last verified: April 2014

May 23, 2012
April 4, 2014
November 2012
May 2015   (final data collection date for primary outcome measure)
CSME needing treatment either photocoagulation or ITV. [ Time Frame: Months 0, 6, 12 and 24. ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01607190 on ClinicalTrials.gov Archive Site
  • Best corrected visual acuity. [ Time Frame: Months 0, 6, 12 and 24. ] [ Designated as safety issue: Yes ]
  • Vision loss of at least 2 lines documented in ETDRS charts [ Time Frame: Months 0, 6, 12 and 24. ] [ Designated as safety issue: Yes ]
  • Central retinal thickness [ Time Frame: Months 0, 6, 12 and 24. ] [ Designated as safety issue: Yes ]
  • Microaneurysm(MA) activity (number of MA, MA formation and MA disappearance rates and MA turnover) [ Time Frame: Months 0, 6, 12 and 24. ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Biomarkers of Diabetic Retinopathy Progression
Biomarkers of Diabetic Retinopathy Progression.

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
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Non-Probability Sample

Patients with type 2 diabetes mellitus and mild nonproliferative diabetic retinopathy

  • Type 2 Diabetes Mellitus
  • Mild Nonproliferative Diabetic Retinopathy
Not Provided
Patients with diabetic retinopathy.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
November 2015
May 2015   (final data collection date for primary outcome measure)

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.
Both
35 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Portugal,   India
 
NCT01607190
4C-2012-02
No
Association for Innovation and Biomedical Research on Light and Image
Association for Innovation and Biomedical Research on Light and Image
Not Provided
Study Chair: José Cunha-Vaz, MD, PhD Association for Innovation and Biomedical Research on Light and Image
Association for Innovation and Biomedical Research on Light and Image
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP