Study on the Biomarkers of Anti-VEGF Treatment for Choroidal Neovascularization

Choroidal Neovascularization Clinical Trial

Official title:

Study on the Biomarkers to Predict the Response to Anti-vascular Endothelial Growth Factor Treatment for Choroidal Neovascularization

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06243406
• Other study ID #: BJ-2022-012
• Status: Not yet recruiting
• 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
• 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
• 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

Related Conditions & MeSH terms

• Choroidal Neovascularization
• Neovascularization, Pathologic

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