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The clinical research of Yiqi Yangyin Huoxue Lishui combined with aflibercept on diabetic macular edema

The clinical research of Yiqi Yangyin Huoxue Lishui combined with aflibercept on diabetic macular edema

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046527
Enrollment
Unknown
Registered
2021-05-21
Start date
2021-06-01
Completion date
Unknown
Last updated
2022-01-04

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

Conditions

diabetic macular edema

Interventions

Sponsors

Chongqing Aier Eye Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Western medicine diagnostic criteria are made according to the diagnostic criteria of "clinically significant macular edema" recommended by and the Early Treatment Diabetic Retinopathy Study (ETDRS) in the United States: 1.Having a clear history of diabetes; 2.Macular edema or associated with the following lesions, including microangioma, retinal hemorrhage, hard exudation, and cotton spots, were observed under ophthoscope; 3.There was retinal thickening in the area of 500um in the macular center, OCT showed macular thickness > 250um, and FFA showed luciferin leakage in the macular area; 4.At the same time, according to the standard of macular edema recommended by ETDRS, the classification was carried out. (1)Local edema: FFA showed that lucilucin leakage mainly came from single or cluster microhemangiomas in macular area, or from a small segment of dilated capillaries, and late leakage only occupied local area of macular area; (2)Diffuse edema type: FFA showed luciferin leakage from retinal and/or choroidal capillaries, forming extensive luciferin leakage, occupying the whole macular area; (3)Macular cystic edema type: FFA showed that late macular formation of petal-like and/or beehive-like fluorescein leakage, often accompanied by diffuse macular edema, can also occur alone, statistically classified as diffuse edema type. TCM diagnostic criteria refer to the standard of Qi and Yin deficiency syndrome in : visual faintness, retinal macular edema, retinal bleeding and exudation can be seen in the fundus of the disease; Complexion, God tired little gas, dry pharynx, five upset hot; Light tongue, weak or astringent pulse. 1.Conform to the above-mentioned western and traditional Chinese medicine diagnostic criteria; 2.Control of blood glucose and blood pressure, HbA1c < 8.3%, fasting blood glucose. 8.3mmol/L, 2h postprandial blood glucose < 11.1mmol/L, blood pressure < 150/90 mmHg. 3.To complete treatment and follow-up for at least 5 months; 4.All patients were informed of the study and signed the consent form.

Exclusion criteria

Exclusion criteria: 1.Systemic patients with severe cardiovascular and cerebrovascular diseases, liver and kidney insufficiency, or blood diseases; 2.Allergic to sodium fluorescein; 3.Pregnant or lactating women; 4.Psychopaths. 5.Local retinal pulling or detachment of the eye; 6.After the operation, the vitreous cavity was filled with gas or silicone oil. 7.History of vitreoretinal surgery; 8.DME secondary to non-diabetic retinopathy; 9.The opacity of the refractive interstitium affects the observer.

Design outcomes

Primary

MeasureTime frame
Best corrected visual acuity;Mean retinal thickness and blood flow in the macular fovea with a diameter of 1mm;

Secondary

MeasureTime frame
Multifocal electroretinograms;Determination of drug concentration of abercep in vitreous body fluids;The expression of HIF-1a, TNF-a, SICAM-1 and VEGF in vitreous body fluids were detected;Fundus camera;

Countries

China

Contacts

Public ContactChen Mei

Chongqing Aier Eye Hospital

cm-8988@163.com+86 19923132168

Outcome results

None listed

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