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Clinical study on the intervention effect of resolving dampness and activating blood circulation on CI-DME

Clinical study on the intervention effect of resolving dampness and activating blood circulation on CI-DME based on the Regulation of cathepsinD

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100005414
Enrollment
Unknown
Registered
2021-12-17
Start date
2021-12-17
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetic macular edema

Interventions

Group 2:anti-VEGF therapy
Group 1:anti-VEGFtherapy+Prescription for resolving dampness and activating blood circulation

Sponsors

Affiliated Hospital of Nanjing University of Chinese Medicine(Jiangsu Province Hospital of Chinese Medicine)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. In accordance with the diagnostic criteria of type 2 diabetes, macular edema was diagnosed by OCT or FFA examination, the age was 18-75 years old, regardless of sex. 2. There were no acute complications of diabetes (hyperglycemia and hyperosmotic state of diabetes, diabetic ketoacidosis, etc.), fasting blood glucose (10mml/L) and blood pressure (150/90mmHg). 3. TCM syndrome differentiation is deficiency of both qi and yin, dampness and blood stasis blocking collaterals. 4. Informed consent, volunteer subjects. The process of obtaining informed consent shall comply with GCP regulations.

Exclusion criteria

Exclusion criteria: 1. Previous history of ocular trauma, vitreous surgery, glaucoma, FFA with uveitis or other retinal diseases. 2. Recently, there are serious systemic diseases such as myocardial infarction, cerebral infarction and severe refractive interstitial opacity that affect fundus observation. 3. Patients with diabetic macular edema who have received intravitreal or peribulbar injection of corticosteroids. 4. The poor image quality can not complete the image analysis. 5. History of thromboembolism, abnormal blood coagulation, ongoing use of anticoagulants (except aspirin), or other serious systemic diseases. 6. A person who is unable to give full informed consent due to intellectual or behavioral impairment. 7. Suspect or have a history of alcohol or drug abuse. 8. According to the judgment of the researchers, other pathological changes that reduce or complicate the possibility of enrollment, such as frequent changes in the working environment, are easy to cause loss of follow-up. 9. Allergic constitution, such as those who have a history of allergy to two or more drugs or food; or those who are known to be allergic to the ingredients of this drug. 10. Patients who are participating in clinical trials of other drugs.

Design outcomes

Primary

MeasureTime frame
best corrected vision acuity;central Retinal thickness;

Secondary

MeasureTime frame
superficial capillary plexus-retinal vascular density;

Countries

China

Contacts

Public ContactHao wu
hal20151317@163.com15950570210

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026