An observational study in Diabetic Retinopathy, Diabetic Macular Edema and Diabetes Mellitus, sponsored by Novartis Slovakia, s.r.o.. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-09-22.
Sponsored by Novartis Slovakia, s.r.o. · Observational
The aim of the study is to find out prevalence and individual stages of Diabetic Retinopathy in patients with type 1 and type 2 DM verified based on complex ophthalmologic measurements in Slovak Republic. The outcome of the project will be epidemiology survey, prevalence of diabetic retinopathy (DR) and diabetic macular edema (DME) in relation to type and duration of diabetes mellitus and risk factors. Project will also identify genetic factors linked with the diseases.
841 studies on the registry are indexed under Macular Edema; 56 are open to participants now.
This study's enrollment of 4,011 is above the median of 97 across 163 observational studies indexed under Macular Edema.
Browse Macular Edema studies →Novartis Slovakia, s.r.o. is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Total expected number of patients included in this survey is 5000. With the objective to guarantee non-biased patient selection sample, each screening day the pre-specified sequence of patients (5th, 10th, 15th...) will selected. If the pre-selected patient does not come for visit or does not fulfill the inclusion criteria or does not want to sign the informed consent the next patient is asked to participate in the research. We plan to enroll 4500 patients using this non-biased method.
The weakness of the non-biased random selection is that the less frequent groups of patients will not have enough subjects for the proper statistical analysis. To correct for this effect pool of 500 patients is reserved for special subgroups. Pre-defined subgroups are:
Exclusion Criteria:
For the purpose of DNA isolation prior to genetic analysis of patients two samples of peripheral blood will be taken; first in the volume of 3.5 ml and second in the volume of 9 ml from each patient included into the study.
The prevalence of diabetic retinopathy as the proportion of patients with DR (any stage) in a given subgroup according to DM duration
The results will be accompanied by Wald 95% confidence intervals. The combined prevalence results from more subgroups will be evaluated using weighted average using the best available epidemiology data.
Time frame: participants screened each working day within 8 working hours during a 6 months period in selected diabetology centers according to protocol criteria
Evaluate the prevalence and individual stages of Diabetic Retinopathy in patients with type 1 and type 2 DM verified based on complex ophthalmologic measurements
The calculation of prevalence for each stage of DR will be analyzed using the same methods as for the total DR prevalence.
Time frame: participants screened each working day within 8 working hours during a 6 months period in selected diabetology centers according to protocol criteria
Evaluate the prevalence and individual stages of Diabetic Macular Edema (DME) in patients with type 1 and type 2 DM verified based on complex ophthalmologic measurements
The calculation of prevalence for each stage of DME will be analyzed using the same methods as for the total DR prevalence
Time frame: participants screened each working day within 8 working hours during a 6 months period in selected diabetology centers according to protocol criteria
Evaluate the impact of risk factors on the prevalence of Diabetic Retinopathy and Diabetic Macular Edema
The analysis will be realized using multivariate logistics regression. The output of the analysis will be the impact statistical significance of the individual risk factors represented by odds ratio for each risk parameter accompanied with statistical significance and corresponding confidence interval. The risk factors will be at least: age, gender, ethnicity, DM duration since diagnosis, glycemic control and diabetes management based on the average HbA1c of all measurements in the last 12 months, presence of nephropathy, malignancies and BMI. Age, DM duration since diagnosis, diabetes control based on the average HbA1c of all measurements in the last 12 months and BMI will be assessed as continuous covariates whereas gender, nationality, presence of nephropathy and malignancies will be considered as categorical variables.
Time frame: participants screened each working day within 8 working hours during a 6 months period in selected diabetology centers according to protocol criteria
Epidemiological characteristics of patients with Diabetes Mellitus and with Diabetic Retinopathy in terms of demographic structure, treatment and control of DM and the presence of other microvascular and ophthalmologic complications
The patient characteristics will be described as by standard methods of descriptive statistics - N, %, mean, media, min, max, SD and where necessary accompanied by the histogram or contingence table.
Time frame: participants screened each working day within 8 working hours during a 6 months period in selected diabetology centers according to protocol criteria
Evaluate the impact of diabetic retinopathy and diabetes mellitus on the Quality Of Life as measured by NEI-VFQ25 questionnaires
The impact of DR and DME on the quality of life in case of patients with DM will be realized using ANCOVA method where QoL will be evaluated as the continuous variable. The multivariate analysis will include all relevant patient characteristics including visual acuity, age and gender of the patient. These characteristics will serve as covariates to correct for the difference in characteristics of patient with/without DR.
Time frame: participants examined each working day within selected working hours during a 6 months period in selected ophthalmology centers according to protocol criteria
Investigate DNA polymorphisms and phenotypic features correlating with the development of DR in patients with extreme phenotypes.
Genetic analysis is primarily exploratory in nature, does not test the hypothesis previously postulated and formal calculation of sample size can not be determined. In combination with accurately determined ocular and diabetic history is sample size above standard within typical publications of the topic.
Time frame: DNA analysis during 7 months post study screening period
The analysis of mitochondrial DNA haplotypes in pre-defined patient groups
Basic statistical analysis will include binary logistic regression (OR, 95% CI) and Fisher test. This method evaluates the statistical significance for the increase or decrease in the risk of DR for easy single nucleotide polymorphisms (SNPs) in in mitochondrial DNA (mtDNA), their combinations - DNA haplotypes, haplogroups and their clusters and thus identifies possible genetic factors involved in the study disease.
Time frame: DNA analysis during 7 months post study screening period
The identification of patients with monogenic DM by biomarkers (hsCRP)
Calculation of prevalence HNF1A-MODY in a wide Slovak population with diabetes using biomarker hsCRP. Comparison of the severity of retinopathy in mutation carriers of HNF1A-MODY and type 2 diabetes / type 1 diabetes patients in the specified data set.
Time frame: DNA analysis during 7 months post study screening period
Identification of patients with extreme phenotypes and family history of DM with eye complications
Time frame: DNA analysis during 7 months post study screening period
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This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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Novartis Slovakia, s.r.o.