Biomarkers of Diabetic Retinopathy Progression

Type 2 Diabetes Mellitus Clinical Trial

— C-Tracer  

Official title:

Biomarkers of Diabetic Retinopathy Progression.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01607190
• Other study ID #: 4C-2012-02
• Status: Completed
• Start date: November 2012
• Est. completion date: December 2017

Study information

• Verified date: July 2018
• Source: Association for Innovation and Biomedical Research on Light and Image
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2017
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetic Retinopathy
• Mild Nonproliferative Diabetic Retinopathy
• Retinal Diseases
• Type 2 Diabetes Mellitus

Locations

Country	Name	City	State
India	LV Prasad Eye Institute	Hyderabad	Andhra Pradesh
Portugal	AIBILI- Association for Biomedical Research and Inovation on Light and Image.	Coimbra

Sponsors (1)

Lead Sponsor	Collaborator
Association for Innovation and Biomedical Research on Light and Image

Countries where clinical trial is conducted

India,  Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CSME needing treatment either photocoagulation or ITV.		Months 0, 6, 12 and 24.
Secondary	Best corrected visual acuity.		Months 0, 6, 12 and 24.
Secondary	Vision loss of at least 2 lines documented in ETDRS charts		Months 0, 6, 12 and 24.
Secondary	Central retinal thickness		Months 0, 6, 12 and 24.
Secondary	Microaneurysm(MA) activity (number of MA, MA formation and MA disappearance rates and MA turnover)		Months 0, 6, 12 and 24.