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

Diabetic Retinopathy Clinical Trial

Official title:

A Multicenter, Randomized, Double-blind Non-inferiority Trial to Evaluate the Efficacy and Safety of Entelon® as Compared to Doxium Tab. And Placebo for the Treatment of Nonproliferative Diabetic Retinopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03962296
• Other study ID #: ENTL_501
• Status: Completed
• Phase: Phase 4
• Start date: November 21, 2012
• Est. completion date: January 26, 2015

Study information

• Verified date: May 2019
• Source: Hanyang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Eligible patients were randomised to one of the three study groups in a 1:2:2 ratio (placebo:GSPE:CD group). The randomization schedule was generated and prepared using cubeIWRS® solution (CRScube Inc., Seoul, South Korea, HQ). Randomization was performed using a complete randomization algorithm according to the order of the baseline visit. Subjects took three tablets of a masked study medication three times daily for 12 months; the first dose was taken in the morning of the baseline visit (T0) after baseline assessments were performed, and the last dose was taken in the evening before the month 12 visit (T12). Three daily oral doses of 50mg tablets of GSPE (Entelon®, Hanlim Pharm, Seoul, South Korea) were administered to patients in the GSPE group. Placebo tablets lacked GSPE, but their appearance was identical to that of the study group tablets. Commercially available 250mg CD tablets (Doxium®, Ilsung Pharm, Seoul, South Korea) were used in this study. The identity of the masked study medications was concealed by storing the medications in individually sealed envelopes at the study sites.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: January 26, 2015
• Est. primary completion date: January 26, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Diseases

Intervention

Drug:
• Vitis vinifera extract
Three daily oral doses of 50mg tablets of Vitis vinifera extract(Entelon®, Hanlim Pharm, Seoul, South Korea) were administered to patients in this group
• Calcium Dobesilate
Three daily oral doses of 50mg tablets of Calcium Dobesilate(Doxium®, Ilsung Pharm, Seoul, South Korea) were administered to patients in this group
• Placebo
Placebo tablets lacked Vitis vinifera extract or calcium dobesilate, but their appearance was identical to those of the study group tablets.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hanyang University	Hanlim Pharm. Co., Ltd.

References & Publications (1)

Spadea L, Balestrazzi E. Treatment of vascular retinopathies with Pycnogenol. Phytother Res. 2001 May;15(3):219-23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change(Improvement)in the hard exduates	The improvement of HE was defined as a decrease in the HE severity by at least two categories of severity at T12 compared with the baseline visit.	T0(baseline), T12(12months)
Secondary	The change of Best-corrected visual acuity(BCVA)	Using the Early Treatment Diabetic Retinopathy Study(ETDRS) protocol	T0(baseline), T3(3months), T6(6months), T9(9months), T12(12months)
Secondary	The change of central subfield mean thickness(CSMT)	Using 6-radial scan protocol or cube scan protocol according to local guidelines of each center;the ETDRS style map	T0(baseline), T3(3months), T6(6months), T9(9months), T12(12months)
Secondary	The change of total macular volum(TMV)	Using 6-radial scan protocol or cube scan protocol according to local guidelines of each center;the ETDRS style map	T0(baseline), T3(3months), T6(6months), T9(9months), T12(12months)