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
  Purpose

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
Type 2 Diabetes Mellitus
Mild Nonproliferative Diabetic Retinopathy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Biomarkers of Diabetic Retinopathy Progression.

Resource links provided by NLM:


Further study details as provided by Association for Innovation and Biomedical Research on Light and Image:

Primary Outcome Measures:
  • CSME needing treatment either photocoagulation or ITV. [ Time Frame: Months 0, 6, 12 and 24. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 200
Study Start Date: November 2012
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with diabetic retinopathy.

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01607190

Locations
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
Study Chair: José Cunha-Vaz, MD, PhD Association for Innovation and Biomedical Research on Light and Image
  More Information

No publications provided

Responsible Party: Association for Innovation and Biomedical Research on Light and Image
ClinicalTrials.gov Identifier: NCT01607190     History of Changes
Other Study ID Numbers: 4C-2012-02
Study First Received: May 23, 2012
Last Updated: April 4, 2014
Health Authority: Portugal: Ethics Committee for Clinical Research

Keywords provided by Association for Innovation and Biomedical Research on Light and Image:
type 2 diabetes mellitus
nonproliferative diabetic retinopathy

Additional relevant MeSH terms:
Diabetic Retinopathy
Diabetes Mellitus
Diabetes Mellitus, Type 2
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 29, 2014