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An open label, randomized control trial on the effect of Xuesaitong soft capsule combined with anti-vascular endothelial growth factor drug (anti-VEGF drug) in the treatment of retinal vein occlusion with macular edema

An open label, randomized control trial on the effect of Xuesaitong soft capsule combined with anti-vascular endothelial growth factor drug (anti-VEGF drug) in the treatment of retinal vein occlusion with macular edema

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100049861
Enrollment
Unknown
Registered
2021-08-10
Start date
2021-08-01
Completion date
Unknown
Last updated
2022-04-19

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

Conditions

retinal vein occlusion with macular edema

Interventions

Experimental group:Anti-vascular endothelial growth factor drugs + basic therapy

Sponsors

Affiliated Hospital of Yunnan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Those who meet the diagnostic criteria of western medicine retinal vein occlusion combined with macular edema, including central retinal vein occlusion and branch retinal vein occlusion; 2. The foveal retinal thickness >= 250 µm in the OCT examination of the target eye; 3. Diagnosis time < 6 months; 4. Those who need to receive intravitreal injection of anti-vascular endothelial growth factor drugs (anti-VEGF drugs) for the first time; 5. The target eye's best corrected visual acuity BCVA<=73 letters (equivalent to Snellen20/40); 6. Aged 18 to 75 years (including 18 and 75 years old); 7. Voluntary subjects and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Macular edema not caused by retinal vein occlusion; 2. Any eye with optic disc, retina, iris neovascularization; 3. Any eye with diabetic retinopathy, retinal detachment, proliferative retinopathy, age-related macular degeneration, glaucoma, severe cataract, retinal vascular disease caused by inflammation and other eye diseases that affect the judgment of efficacy; 4. Active eye infection in the target eye and/or the fellow eye; 5. The target eye has used corticosteroids in or around the eye within 3 months; 6. The target eye has undergone the following ophthalmic surgeries (PDT, macular transposition, glaucoma filtration, subfoveal photocoagulation, etc.) and other submacular surgeries; 7. The target eye is expected to undergo retinal dissemination photocoagulation or other laser photocoagulation surgery, scleral buckle and other intraocular surgery during the study period; 8. Any eye received intravitreal injection of anti-VEGF drugs within 3 months before screening; 9. Those with a history of stroke, history of myocardial infarction and/or cerebrovascular disease, temporary cerebral ischemia within 6 months before screening, and those with active disseminated intravascular coagulation and obvious bleeding tendency; 10. Patients with serious primary diseases and dysfunctions of the heart, brain, liver, kidney, hematopoietic system, and endocrine system; 11. Patients with severe hypertension, systolic blood pressure >= 160 mmHg, diastolic blood pressure > 90 mmHg or hypotension (resting sitting blood pressure) systolic blood pressure <= 90 mmHg, diastolic blood pressure <= 50 mmHg) after drug control; 12. Those who are alcohol dependent or have a history of drug abuse; 13. Women who are pregnant or breastfeeding or planning to become pregnant during the experiment; 14. Allergic constitution or previous allergic to multiple drugs, or allergic to sodium fluorescein, research drugs and ingredients (ginseng, Panax notoginseng); 15. Participated in other clinical investigators within 3 months before the experiment; 16. Other patients considered by the investigator to be inappropriate to participate in this study.

Design outcomes

Primary

MeasureTime frame
foveal retinal thickness;Change in best corrected visual acuity from baseline;

Countries

China

Contacts

Public ContactWu Min

Affiliated Hospital of Yunnan University

ynwumin@126.comm+86 18908809399

Outcome results

None listed

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