Clincosm LogoSign in Get a demo

C-Tracer: Biomarkers of Diabetic Retinopathy Progression

Sponsor
Association for Innovation and Biomedical Research on Light and Image (Other)
Overall Status
Completed
CT.gov ID
NCT01607190
Collaborator
(none)
200
Enrollment
2
Locations
61
Duration (Months)
100
Patients Per Site
1.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Biomarkers of Diabetic Retinopathy Progression.
    Study Start Date :
    Nov 1, 2012
    Actual Primary Completion Date :
    Apr 1, 2016
    Actual Study Completion Date :
    Dec 1, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    Patients with diabetic retinopathy.

    Outcome Measures

    Primary Outcome Measures

    1. CSME needing treatment either photocoagulation or ITV. [Months 0, 6, 12 and 24.]

    Secondary Outcome Measures

    1. Best corrected visual acuity. [Months 0, 6, 12 and 24.]

    2. Vision loss of at least 2 lines documented in ETDRS charts [Months 0, 6, 12 and 24.]

    3. Central retinal thickness [Months 0, 6, 12 and 24.]

    4. Microaneurysm(MA) activity (number of MA, MA formation and MA disappearance rates and MA turnover) [Months 0, 6, 12 and 24.]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    35 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 LV Prasad Eye Institute Hyderabad Andhra Pradesh India 500 034
    2 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Association for Innovation and Biomedical Research on Light and Image
    ClinicalTrials.gov Identifier:
    NCT01607190
    Other Study ID Numbers:
    • 4C-2012-02
    First Posted:
    May 30, 2012
    Last Update Posted:
    Jul 19, 2018
    Last Verified:
    Jul 1, 2018
    Keywords provided by Association for Innovation and Biomedical Research on Light and Image
    type 2 diabetes mellitus
    nonproliferative diabetic retinopathy
    Additional relevant MeSH terms:
    Retinal Diseases
    Diabetic Retinopathy
    Diabetes Mellitus
    Diabetes Mellitus, Type 2

    Study Results

    No Results Posted as of Jul 19, 2018