Diabetic retinopathy MedDRA version: 19.1 Level: PT Classification code 10012689 Term: Diabetic retinopathy System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Trade Name: Doxium 500
Product Name: Calcium dobesilate monohydrate
Pharmaceutical Form: Capsule
INN or Proposed INN: DOXIUM
Other descriptive name: CALCIUM DOBESILATE MONOHYDRATE
Concentration unit:
Sponsors
Fundació Hospital Universitari Vall d'Hebron - Institut de Recersa (VHIR)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients with type 2 diabetes mellitus. • Subclinical diabetic macular edema. • ETDRS score 20-47. • Duration of diabetes = 5 years. • Age between 45 and 70 years (both included) • HbA1c =7% and =8.5% in the previous 6 months and at screening. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Medical record of laser photocoagulation. • Presence of any retinal disease other than diabetic retinopathy. • Patients with a refractive error of =5 diopters in one of the two eyes. • Pupillary dilation or any eye defect that does not allow good quality images of fundus. • Medical record of ocular surgery in the 6 months prior to randomization. • Advanced chronic kidney disease (= stage 4). •known Allergy or intolerance ti IMP •Pregnancy or child-bearing age women that don't accept or can't use anticonceptive methodes during all the study •Patients that cannot follow the study indications •Use of an IMP within the last 30 days prior to screening visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: • To assess whether Doxium® is able to slow the progression of subclinical diabetic macular edema (DME) to clinically significant DME. • To determine whether Doxium® is able to slow the progression of diabetic retinopathy assessed by ETDRS (= 1 level). • To assess whether Doxium® is able to slow the progression of neurodegenerative changes. • To evaluate whether Doxium® is able to slow the reduction of visual acuity. • To predict whether Doxium® is able to slow the progression of foveal microvascular changes. • To examine potential changes in the morphology and function of the choroid. • To assess the safety of Doxium®, including adverse events, serious adverse events, analytical data and vital signs.;Primary end point(s): The increase in retinal thickness measured by SD-OCT from the beginning to the end of the study.;Timepoint(s) of evaluation of this end point: 0 months, 4 months, 8 months and 12 months;Main Objective: To determine whether Doxium® is able to prevent or reduce thickening of the retina. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - The severity of diabetic retinopathy measured with the ETDRS scale. - Retinal nerve fiber layer measured with OCT. - The layer of ganglion cells measured with OCT. - Visual acuity on the ETDRS scale. - Foveal microvessels changes evaulated by anti-OCT. - Choroidal anomalies assessed by OCT. - Safety, including adverse effects and laboratory results.;Timepoint(s) of evaluation of this end point: Depending on the endpoint the timepoint will be different: 0 months, 4 months, 8 months and 12 months | — |
Countries
Spain
Contacts
Public ContactRafael Simó
Fundació Hospital Universitari Vall d'Hebron - Institut de Recersa (VHIR)
Outcome results
None listed