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Biomarkers of Diabetic Retinopathy Progression

This study is currently recruiting participants.
Verified April 2013 by Association for Innovation and Biomedical Research on Light and Image
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 5, 2013
Last verified: April 2013
History of Changes
  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:

U.S. FDA Resources

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

Contacts
Contact: Sandrina Nunes 00351239480137 4C@aibili.pt
Contact: Ana Pedroso 00351239480131 4C@aibili.pt

Locations
India
LV Prasad Eye Institute Not yet recruiting
Hyderabad, Andhra Pradesh, India, 500 034
Contact: Rajeev Reddy Pappuru, MD            
Principal Investigator: Rajeev Reddy Pappuru, MD            
Portugal
AIBILI- Association for Biomedical Research and Inovation on Light and Image. Recruiting
Coimbra, Portugal, 3000-548
Contact: Luísa Ribeiro, MD     00351239480124     lr@aibili.pt    
Contact: Isabel Simões     00351239480126     isimoes@aibili.pt    
Principal Investigator: Luísa Ribeiro, MD            
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 5, 2013
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 May 19, 2013