A Multicenter, Randomized, Double-blind Non-inferiority Trial to Evaluate the Efficacy and Safety of Entelon®

• Status: Completed
• Trial end date: 2015-01-26
• Target enrollment: 0
• Participant gender: All

Summary

This was a multicentre, randomised, double-blind controlled study that compared the efficacy and safety of V. vinifera extract, calcium dobesilate (CD), and placebo in subjects with DME. Patients made 6 clinic visits, namely the screening visit; baseline visit (T0); and follow-up visits at 3 (T3), 6 (T6), 9 (T9), and 12 (T12) months.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hanyang University
• Collaborator: Hanlim Pharm. Co., Ltd.
• Treatments: Calcium; Calcium Dobesilate; Calcium, Dietary

Criteria

Inclusion Criteria:

• Singing a written informed consent prior to selection

• type 2 DM aged between 40 and 80 years

• Diabetes is well controlled with drugs for at least 3 months(HbA1c ≤9%)

• Best-corrected visual acuity over 0.5(20/40) by using ETDRS cisual acuity test

• Diabetic macular edema with hard exudates CSMT ≤300µm

Exclusion Criteria:

• Lase therapy or intravitreal injection(anti-VEGF, steroid) intraocular surgery within 6 months of enrollment

• Concomitant macular disease (such as retinal vascular occlusion, choroidal neovascularization, epiretinal membrane, etc)

• Poor image of optical coherence tomography(signal strength under 50% of narmal value)

• Concomitant therapy(Kallidinogenase, Vaccinium myrtillus extract, sulodexide)

• Non-controlled hypertension(systolic pressure >140mmHg or diastolic pressure <90mmHg)

• Severe renal insufficiency(creatinine >2.2mg/dL, or undergoing dialysis)