NCT01607190|Completed
Biomarkers of Diabetic Retinopathy Progression
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Sponsor study identifier
observational
200
2 countries
2
Study Start
November 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2016
Actual (reported)Study Completion
December 2017
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2017
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 23, 2012
Actual (reported)May 30, 2012
Actual (reported)November 2012
Date type not reportedThis date has not been verified as actual or estimated.
April 2016
Actual (reported)December 2017
Actual (reported)CSME needing treatment either photocoagulation or ITV.
Months 0, 6, 12 and 24.
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.
Patients with type 2 diabetes mellitus and mild nonproliferative diabetic retinopathy
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
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.
José Cunha-Vaz, MD, PhD
Association for Innovation and Biomedical Research on Light and Image
200 participants (actual enrollment reported by the registry).
First Submitted
May 23, 2012
First Posted
May 30, 2012
Study Start
November 2012
Date type not reportedThis date has not been verified as actual or estimated.
Safety and Efficacy of SPIL1033 in Subjects With Type 2 Diabetes Mellitus
Contact the study team to confirm eligibility.
Primary Completion
April 2016
Actual (reported)Study Completion
December 2017
Actual (reported)Last Updated
July 19, 2018
Record last verified: 2018-07
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Source: ClinicalTrials.gov.
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