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Clinical evaluation and mechanism study on the synergistic treatment and rehabilitation of diabetic macular edema by Chinese and Western medicine

Clinical evaluation and mechanism study on the synergistic treatment and rehabilitation of diabetic macular edema by Chinese and Western medicine

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2022000026
Enrollment
Unknown
Registered
2022-06-21
Start date
2022-06-27
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

Test group:Conbercept Injection + Xiaozhong granules
Control group:Conbercept Injection +Placebo granules

Sponsors

Eye Hospital, China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Synergistic Chinese and Western medicine treatment program, Synergistic Chinese and Western medicine low vision rehabilitation program. (1) Those with poorly cleared refractive interstitium and difficulty in fundus observation. (2) Those who have already undergone vitreous cavity injection of anti-VEGF or hormonal drugs, gridded photocoagulation, local photocoagulation, or total retinal photocoagulation within 3 months after any one or more of these treatment modalities. (3) Those with combined fundus disease such as glaucoma, retinal vein obstruction, uveitis, or optic nerve disease. (4) Patients with combined severe cardiovascular, hepatic and hematopoietic system diseases and diabetic nephropathy with renal failure; HBA1c = 10% and liver and kidney function test results exceeding 1.5 times normal (5) Patients with combined serious life-threatening primary diseases and psychiatric disorders (6) Pregnant or lactating women. (7) Those who are participating in clinical trials of other drugs or are taking drugs that may affect the clinical evaluation of this study. (8) Inability to cooperate during the examination and to adhere to the follow-up fundus examination.

Exclusion criteria

Exclusion criteria: Synergistic Chinese and Western medicine treatment program, Synergistic Chinese and Western medicine low vision rehabilitation program. (1) Those with poorly cleared refractive interstitium and difficulty in fundus observation. (2) Those who have already undergone vitreous cavity injection of anti-VEGF or hormonal drugs, gridded photocoagulation, local photocoagulation, or total retinal photocoagulation within 3 months after any one or more of these treatment modalities. (3) Those with combined fundus disease such as glaucoma, retinal vein obstruction, uveitis, or optic nerve disease. (4) Patients with combined severe cardiovascular, hepatic and hematopoietic system diseases and diabetic nephropathy with renal failure; HBA1c = 10% and liver and kidney function test results exceeding 1.5 times normal (5) Patients with combined serious life-threatening primary diseases and psychiatric disorders (6) Pregnant or lactating women. (7) Those who are participating in clinical trials of other drugs or are taking drugs that may affect the clinical evaluation of this study. (8) Inability to cooperate during the examination and to adhere to the follow-up fundus examination.

Design outcomes

Primary

MeasureTime frame
Macular central fovea thickness;Best corrected visual acuity;

Secondary

MeasureTime frame
macular area no vascular area;Fixation stability;macular area blood flow density;TCM syndrom score; macular retinal sensitivity;

Countries

China

Contacts

Public ContactChuanhong Jie
jiechuanhong@163.com13671359790

Outcome results

None listed

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