Biomarkers of Diabetic Retinopathy Progression
C-Tracer
1 other identifier
observational
200
2 countries
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2012
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2012
CompletedFirst Posted
Study publicly available on registry
May 30, 2012
CompletedStudy Start
First participant enrolled
November 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedJuly 19, 2018
July 1, 2018
3.4 years
May 23, 2012
July 18, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
CSME needing treatment either photocoagulation or ITV.
Months 0, 6, 12 and 24.
Secondary Outcomes (4)
Best corrected visual acuity.
Months 0, 6, 12 and 24.
Vision loss of at least 2 lines documented in ETDRS charts
Months 0, 6, 12 and 24.
Central retinal thickness
Months 0, 6, 12 and 24.
Microaneurysm(MA) activity (number of MA, MA formation and MA disappearance rates and MA turnover)
Months 0, 6, 12 and 24.
Study Arms (1)
Patients with diabetic retinopathy.
Eligibility Criteria
Patients with type 2 diabetes mellitus and mild nonproliferative diabetic retinopathy
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
LV Prasad Eye Institute
Hyderabad, Andhra Pradesh, 500 034, India
AIBILI- Association for Biomedical Research and Inovation on Light and Image.
Coimbra, 3000-548, Portugal
Related Publications (1)
Cunha-Vaz J, Ribeiro L, Costa M, Simo R. Diabetic Retinopathy Phenotypes of Progression to Macular Edema: Pooled Analysis From Independent Longitudinal Studies of up to 2 Years' Duration. Invest Ophthalmol Vis Sci. 2017 May 1;58(6):BIO206-BIO210. doi: 10.1167/iovs.17-21780.
PMID: 28785768DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
José Cunha-Vaz, MD, PhD
Association for Innovation and Biomedical Research on Light and Image
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2012
First Posted
May 30, 2012
Study Start
November 1, 2012
Primary Completion
April 1, 2016
Study Completion
December 1, 2017
Last Updated
July 19, 2018
Record last verified: 2018-07