Clinical efficacy and mechanism of dexamethasone intravitreal implant combined with compound salvia miltiorrhiza dropping pills in the treatment of refractory diabetes macular edema

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400093538

Enrollment

Unknown

Registered

2024-12-06

Start date

2025-01-01

Completion date

Unknown

Last updated

2024-12-09

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

Conditions

refractory diabetes macular edema

Interventions

experimental group:Dexamethasone intravitreal implant (IDI) combined with compound Danshen dripping pills

control group:Dexamethasone intravitreal implant (IDI)

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

Inclusion criteria: (1) Type 2 diabetes was diagnosed by endocrine department; (2) Diagnosed with DME through slit lamp, fundus photography, fundus fluorescein angiography, SD-OCT and other examinations; (3) After at least 3 treatments with anti VEGF drugs, SD-OCT examination still shows CRT>300 µ m; (4) Before IDI injection therapy, intraocular pressure (IOP) was normal (10-21 mm Hg); (5) Good compliance, able to complete the study and receive follow-up; (6) The anterior segment is normal, the refractive medium is clear, and the fundus can be seen clearly.

Exclusion criteria

Exclusion criteria: (1) Previously received oral compound Danshen Dropping Pills, intraocular injection of IDI and other glucocorticoid treatments, and other intraocular surgeries except for vitreous anti VEGF injection; (2) Individuals allergic to contrast agents and drugs; (3) Opacity of refractive media seriously affects fundus examination; (4) Patients with previous glaucoma, elevated IOP, or shallow anterior chamber; (5) Unable to cooperate in completing OCT examination; (6) Individuals with severe cardiovascular, hepatic, and hematopoietic system diseases; (7) Individuals with primary and mental illnesses that pose a serious threat to their lives; (8) Pregnant or lactating women; (9) Participants in clinical trials of other drugs.

Design outcomes

Primary

Measure	Time frame
CMT;	—

Secondary

Measure	Time frame
BCVA;IOP;Adverse events recorded during treatment;Expression of factors;	—

Countries

china

Contacts

Public ContactQingquan Wei

Tong Ren Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, People’s Republic of China

weiqingquanwqq@aliyun.com+86 181 1631 0318

Outcome results

None listed

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