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

February 6, 2024 updated by: Beijing Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

80

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
choroidal thickness
Time Frame: 3 months
central choroidal thickness measured by SS-OCTA
3 months
Central retinal thickness
Time Frame: 3 months
central retinal thickness changes measured by SS-OCTA
3 months
Best-corrected visual acuity
Time Frame: 3 months
Best-corrected visual acuity changes from baseline to 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
choroidal vascularity index
Time Frame: 3 months
the ratio of vascular area to the total choroidal area measured by SS-OCTA
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 10, 2024

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

January 29, 2024

First Submitted That Met QC Criteria

January 29, 2024

First Posted (Actual)

February 6, 2024

Study Record Updates

Last Update Posted (Actual)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BJ-2022-012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Choroidal Neovascularization

Clinical Trials on Intravitreal injection of anti-VEGF

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Trinidad & Tobago

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe