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

NCT06243406 | Not Yet Recruiting

• 1 other identifier: BJ-2022-012
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Choroidal Neovascularization

Outcome Measures

Primary Outcomes (3)

• choroidal thickness

  central choroidal thickness measured by SS-OCTA

  3 months

• Central retinal thickness

  central retinal thickness changes measured by SS-OCTA

  3 months

• Best-corrected visual acuity

  Best-corrected visual acuity changes from baseline to 3 months

  3 months

Secondary Outcomes (1)

• choroidal vascularity index

  3 months

Interventions

Intravitreal injection of anti-VEGF OTHER

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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients diagnosed with choroidal neovascularization, who received standard 3-monthly anti-VEGF treatment.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Hospital: lead

MeSH Terms

Conditions

Choroidal Neovascularization

Condition Hierarchy (Ancestors)

Choroid Diseases; Uveal Diseases; Eye Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: February 6, 2024
• Study Start: February 10, 2024
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share