Effect of calcium dobesilate in early stages of diabetic retinopathy

Phase 1

• Conditions: Diabetic retinopathy; MedDRA version: 19.1Level: PTClassification code 10012689Term: Diabetic retinopathySystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2017-000250-19-ES
• Lead Sponsor: Fundació Hospital Universitari Vall d'Hebron - Institut de Recersa (VHIR)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-04-07
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

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

• 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified