AzTrials
AzTrials

Diabetic RetinopathyPhase 4NCT03962296

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

A Phase 4 study testing Vitis vinifera extract and Calcium Dobesilate in people with Diabetic Retinopathy, run by Hanyang University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Diabetic Retinopathy
What is being tested?
Vitis vinifera extract and Calcium Dobesilate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
153 participants
Where
No sites listed yet
Study dates
21 Nov 2012to 26 Jan 2015
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

About this study

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

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.

Read the detailed 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.

Being tested
Vitis vinifera extract, Calcium Dobesilate, Placebo
Keywords
Diabetic retinopathy, hard exudates
Medical subject headings
Diabetic Retinopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vitis vinifera extractDrug

    Also called Experimental: Entelon

    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 DobesilateDrug

    Also called Active comparator:Doxium

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

  • PlaceboDrug

    Also called Placebo comparator:Placebo

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

Study groups in NCT03962296
Study groupRoleWhat they receive
EntelonExperimentalThree daily oral doses of 50mg tablets were administered to patients
Receives: Drug: Vitis vinifera extract
DoxiumActive comparatorThree daily oral doses of 250mg tablets were administered to patients
Receives: Drug: Calcium Dobesilate
PlaceboPlacebo comparatorThree masking tablets were administered to patients
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: T0(baseline), T12(12months)

Secondary outcomes (3)

  1. The change of Best-corrected visual acuity(BCVA)

    Using the Early Treatment Diabetic Retinopathy Study(ETDRS) protocol

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

  2. 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

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

  3. 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2019
  2. Study start21 Nov 2012
  3. Primary completion26 Jan 2015
  4. Study completion26 Jan 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
153 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03962296
Sponsor's protocol ID
ENTL_501
Status last verified
May 2019
First submitted
16 May 2019
Last updated
24 May 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

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

    PubMed 11351356

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Vitis vinifera extract and Calcium Dobesilate in people with Diabetic Retinopathy, run by Hanyang University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 May 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The change(Improvement)in the hard exduates (time frame: T0(baseline), T12(12months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03962296, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in