NCT03962296

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
153

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2012

Typical duration for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 21, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 26, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 26, 2015

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

May 16, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 24, 2019

Completed
Last Updated

May 24, 2019

Status Verified

May 1, 2019

Enrollment Period

2.2 years

First QC Date

May 16, 2019

Last Update Submit

May 23, 2019

Conditions

Diabetic Retinopathy

Keywords

Diabetic retinopathy, hard exudates

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • The change of Best-corrected visual acuity(BCVA)

    T0(baseline), T3(3months), T6(6months), T9(9months), T12(12months)

  • The change of central subfield mean thickness(CSMT)

    T0(baseline), T3(3months), T6(6months), T9(9months), T12(12months)

  • The change of total macular volum(TMV)

    T0(baseline), T3(3months), T6(6months), T9(9months), T12(12months)

Study Arms (3)

Entelon

EXPERIMENTAL

Three daily oral doses of 50mg tablets were administered to patients

Drug: Vitis vinifera extract

Doxium

ACTIVE COMPARATOR

Three daily oral doses of 250mg tablets were administered to patients

Drug: Calcium Dobesilate

Placebo

PLACEBO COMPARATOR

Three masking tablets were administered to patients

Drug: Placebo

Interventions

Vitis vinifera extractDRUG

Three daily oral doses of 50mg tablets of Vitis vinifera extract(Entelon®, Hanlim Pharm, Seoul, South Korea) were administered to patients in this group

Also known as: Experimental: Entelon
Entelon
Calcium DobesilateDRUG

Three daily oral doses of 50mg tablets of Calcium Dobesilate(Doxium®, Ilsung Pharm, Seoul, South Korea) were administered to patients in this group

Also known as: Active comparator:Doxium
Doxium
PlaceboDRUG

Placebo tablets lacked Vitis vinifera extract or calcium dobesilate, but their appearance was identical to those of the study group tablets.

Also known as: Placebo comparator:Placebo
Placebo

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Spadea L, Balestrazzi E. Treatment of vascular retinopathies with Pycnogenol. Phytother Res. 2001 May;15(3):219-23. doi: 10.1002/ptr.853.

    PMID: 11351356RESULT

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

whole grape extractCalcium Dobesilate

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BenzenesulfonatesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsArylsulfonatesArylsulfonic AcidsSulfonic AcidsSulfur AcidsSulfur Compounds

Study Officials

  • Ha kyoung Kim, PhD

    Hallym University Kangnam Sacred Heart Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

May 16, 2019

First Posted

May 24, 2019

Study Start

November 21, 2012

Primary Completion

January 26, 2015

Study Completion

January 26, 2015

Last Updated

May 24, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share