Last updated: July 19, 2022
Sponsor: Hanlim Pharm. Co., Ltd.
Overall Status: Active - Recruiting
Phase
4
Condition
Retina
Diabetic Retinopathy
Treatment
N/AClinical Study ID
NCT05358080
HL-ENTL-402
Ages > 19 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 19 years ≤ age
- Those who are diagnosed as Type 2 diabetes mellitus
- Those whose blood sugar level has been well adjusted to less than 9% of HbA1c withdietary and oral blood sugar lowering durgs for 3 months based on the time ofscreening
- Those who agree to use an effective method of contraception
- Those who provide written consent voluntarily to participate in this clinical trial Inclusion criteria for the study eye
- Those with 0.5(20/40 Snellen lines) or more visual acuity
- Those with 300 micrometers or less central macular thickness
- Those who are diagnosed as mild to moderate NPDR(DRSS levels 35-47)
Exclusion
Exclusion Criteria:
- Those who are diagnosed as proliferative diabetic retinopathy
- Those with macular edema
- Diabetic subjects who have difficulty in controlling blood sugar
- Those whose blood pressure is not well controlled at the time of thescreening(>140/90mmHg)
- Those who, have had stroke or myocardial infarction or arrhythmia that should betreated within 6 months prior to the time of screening
- Subjects with severe renal disorder or severe liver disorder
- Those who have a history of malignant tumors within 5 years prior to the time ofscreening
- Those who are required to receive Kallidinogenase, Vaccinium myrtillus extract,Sulodexide, or Calcium dobesilate during the clinical trial period
- Those who have an allergy to investigational product or any of its excipients
- Those who have an allergy to fluorescein
- Those who have galactose intolerance, lapp lactase deficiency, or glucose-galactosemalabsorption
- Those who have difficulty to get OCT test or Fundus photo test
- Pregnant or lactating woman
- Those with medication of other investigational product within 3 months prior to thetime of randomization
- Patients who are considered to be ineligible for study participation by theinvestigator Exclusion criteria for the study eye
- Those who have a visual defect that can affect the evaluation determined by aninvestigator
- Those who have a opacity that can affect the evaluation determined by an investigator
- Those who have eye diseases that can affect the evaluation determined by aninvestigator
- Those with 25mmHg or more intraocular pressure on a study eye
- Those who are on medication of intravitreal injection of steroid or anti VEGFtreatment or get laser photocoagulation within 6 months prior to the firstadministration
- Those who have a history of a vitrectomy
- Those who have a major ophthalmic surgery history within 3 months prior to the time offirst administration for investigational products
- Those who have a history of yttrium aluminum garnet capsulotomy within 2 months priorto the time of first administration for investigational products
- Those with a phakia
Study Design
Total Participants: 396
Study Start date:
May 27, 2022
Estimated Completion Date:
December 16, 2024
Study Description
Connect with a study center
Hallym University Kangnam Sacred Heart Hospital
Seoul,
Korea, Republic ofActive - Recruiting
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