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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06243406
Other study ID # BJ-2022-012
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date February 10, 2024
Est. completion date October 2024

Study information

Verified date February 2024
Source Beijing Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Choroidal neovascularization (CNV), also known as subretinal neovascularization, is a proliferative change from choroidal capillaries that has become one of the most important causes of blindness worldwide. CNV can occur in a variety of fundus diseases, including pathologic myopia, polypoidal choroidal vasculopathy. At present, intravitreal injection of anti-vascular endothelial growth factor (VEGF) drugs is the first-line effective treatment for CNV. Although a number of clinical studies have shown that the treatment of CNV with anti-VEGF drugs has achieved good visual and anatomical effects, there are still some patients whose CNV has not decreased significantly or even progressed continuously after treatment. Rapid advances in imaging technology have made it possible to explore the quantitative and qualitative characteristics of choroid and CNV, especially swept source optical coherence tomography angiography (SS-OCTA). The objectives are to improve the OCTA typing of CNV and analyze the vascular morphological characteristics of each type; to identify the changes in vascular characteristics of CNV after anti-VEGF treatment in vitreous cavity; and to elucidate the predictive effects of neovascularization and choroidal vascular characteristics on visual acuity and anatomic effects of vitreous anti-VEGF drug treatment for CNV.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date October 2024
Est. primary completion date October 2024
Accepts healthy volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - Age >18 years old - Active choroidal neovascularization (activity criteria: blood vessel leakage confirmed by FFA, or subretinal fluid accumulation or bleeding seen by OCT) - History of anti-VEGF drug therapy - At least 3 months of follow-up data. Exclusion Criteria: - Unable to complete the examination due to severe cataract or vitreous hemorrhage - Any retinal diseases except choroidal neovascularization, such as multifocal choroiditis, diabetic retinopathy - History of intraocular surgery

Study Design


Intervention

Other:
Intravitreal injection of anti-VEGF
Intravitreal injection of anti- vascular endothelial growth factor (VEGF) treatment

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Beijing Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary choroidal thickness central choroidal thickness measured by SS-OCTA 3 months
Primary Central retinal thickness central retinal thickness changes measured by SS-OCTA 3 months
Primary Best-corrected visual acuity Best-corrected visual acuity changes from baseline to 3 months 3 months
Secondary choroidal vascularity index the ratio of vascular area to the total choroidal area measured by SS-OCTA 3 months
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