To study the intervention mechanism of ShenlingBaizhu Powder on diabetic macular edema after anti-VEGF thearpy based on EPO/EPOR pathway-RCT

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300068659

Enrollment

Unknown

Registered

2023-02-27

Start date

2023-03-01

Completion date

Unknown

Last updated

2023-05-22

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

Conditions

diabetic macular edema

Interventions

experimental group:Intravitreal injection of Conbercept + Oral administration of Shenling Baizhu Powder

control group:Intravitreal injection of Conbercept

Eligibility

Sex/Gender

All

Age

40 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Age 40 to 75; 2.It satisfies the type 2 DM diagnostic criteria. 3.Individual fluorescein angiographic examination (FFA) results have a certain DR diagnosis; 4.CMT > 250um; 5.The syndrome of TCM is spleen deficiency syndrome; 6.The anti-VEGF medication was administered more than three months after the final DME-related treatment.

Exclusion criteria

Exclusion criteria: 1. The fundus observer is impacted by reflective interstitial opacity; 2. Patients with disorders that impact their eyesight or fundus, such as glaucoma, optic nerve ischemia, or other ailments; 3. Patients with wet age-related macular degeneration and retinal vein blockage, two conditions that produce macular edema but not DM; 4. A hypertonic coma or severe diabetes mellitus with uncontrolled blood sugar levels and diabetic ketoacidosis; 5. Hemodialysis patients as well as other biochemical indications are unstable; 6. Hepatic and renal insufficiency worsened by major systemic disorders, such as serious heart, brain, kidney, and systemic metabolic diseases (Crea beyond upper limit of normal X1.5, ALT, AST above upper limit of normal X2); 7. Used more medications that can enhance DME's visual function and morphology, and took part in additional clinical trials over the last three months; 8. An allergy to the experimental drug's recognized constituents or a history of allergies; 9. Women who are trying to get pregnant, already pregnant, or nursing; 10. People with mental illness or those who are unable to follow treatment instructions

Design outcomes

Primary

Measure	Time frame
Central thickness of macular (CMT);Best corrected visual acuity(BCVA));Blood flow density in the macula;TCM syndrome efficacy score;	—

Countries

China

Contacts

Public ContactLong Pang

Guangdong Hospital of Traditional Chinese Medicine/ The Second Affiliated Hospital of Guangzhou University of Chinese MedicineMedic ine

1907757091@qq.com13711228733

Outcome results

None listed

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