Anti-VEGF in Real-world

February 2, 2022 updated by: Wenbin Wei

Observation of Anti-vascular Endothelial Growth Factor Therapy in Exudative Age-related Macular Degeneration, Proliferative Diabetic Retinopathy, Macular Edema, and Choroidal Neovascularization.

Anti-vascular endothelial growth factor therapy is the major intervention for treating ischemic retina diseases. According to FDA and China Food and Drug Administration, Ranibizumab, Aflibercept, and Conbercept are major types of anti-vascular endothelial growth factor therapy drugs. In the current study, the primary aim is to observe the visual acuity, anatomy effect of anti-vascular endothelial growth factor therapy in the real-world setting.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Anti-vascular endothelial growth factor therapy is the major intervention for treating ischemic retina diseases, including neovascular age-related macular edema, diabetic macula edema/non-proliferative diabetic retinopathy / proliferative diabetic retinopathy, retinal vein occlusions related macular edema, and choroidal neovascularization secondary to multiple retinal diseases. According to FDA and China Food and Drug Administration, Ranibizumab, Aflibercept, and Conbercept are major types of anti-VEGF drugs. In the current study, the primary aim is to aim to observe the visual acuity, anatomy effect of anti-vascular endothelial growth factor therapy in the real-world setting.

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Wen-Bin Wei

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

35 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with neovascular age-related macular edema (nAMD), diabetic macula edema (DME)/non-proliferative diabetic retinopathy (NPDR)/ proliferative diabetic retinopathy (PDR), retinal vein occlusions related macular edema, and choroidal neovascular (CNV) secondary to multiple retinal diseases.

Description

Inclusion Criteria:

  • Patients with neovascular age-related macular edema (nAMD), diabetic macula edema (DME)/non-proliferative diabetic retinopathy (NPDR)/ proliferative diabetic retinopathy (PDR), retinal vein occlusions related macular edema, and choroidal neovascular (CNV) secondary to multiple retinal diseases.
  • Undergo intravitreal anti-VEGF therapy

Exclusion Criteria:

  • unable to receive OCT examination
  • Severe corneal opacity, cataract that affect OCT examination

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Neovascular age-related macular edema
Patients with new-onset and recurrent Neovascular age-related macular edema.
Drug: Ranibizumab
Ranibizumab 0.5mg/0.05ml intravitreal injection
Drug: Aflibercept
Aflibercept 2.0mg/0.05ml intravitreal injection
Drug: Conbercept
Conbercept 0.5mg/0.05ml intravitreal injection
Diabetic macula edema
Patients with new-onset and recurrent diabetic macula edema
Drug: Ranibizumab
Ranibizumab 0.5mg/0.05ml intravitreal injection
Drug: Aflibercept
Aflibercept 2.0mg/0.05ml intravitreal injection
Drug: Conbercept
Conbercept 0.5mg/0.05ml intravitreal injection
Non-proliferative diabetic retinopathy/proliferative diabetic retinopathy
Patients with new-onset and recurrent non-proliferative diabetic retinopathy/proliferative diabetic retinopathy
Drug: Ranibizumab
Ranibizumab 0.5mg/0.05ml intravitreal injection
Drug: Aflibercept
Aflibercept 2.0mg/0.05ml intravitreal injection
Drug: Conbercept
Conbercept 0.5mg/0.05ml intravitreal injection
Retinal vein occlusions
Patients with new-onset and recurrent retinal vein occlusions
Drug: Ranibizumab
Ranibizumab 0.5mg/0.05ml intravitreal injection
Choroidal neovascularization
Patients with new-onset and recurrent choroidal neovascularization
Drug: Ranibizumab
Ranibizumab 0.5mg/0.05ml intravitreal injection
Drug: Aflibercept
Aflibercept 2.0mg/0.05ml intravitreal injection
Drug: Conbercept
Conbercept 0.5mg/0.05ml intravitreal injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual acuity
Time Frame: 1 year
LogMAR visual acuity
1 year
Central subfield thickness
Time Frame: 1 year
he central subfield is defined as the circular area 1 mm in diameter centered around the center point of the fovea
1 year

Collaborators and Investigators

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

Sponsor

Wenbin Wei

Investigators

  • Study Director: Wenbin Wei, MD, Beijing Tongren 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 (ACTUAL)

January 1, 2022

Primary Completion (ANTICIPATED)

January 1, 2023

Study Completion (ANTICIPATED)

May 1, 2023

Study Registration Dates

First Submitted

December 25, 2021

First Submitted That Met QC Criteria

February 2, 2022

First Posted (ACTUAL)

February 3, 2022

Study Record Updates

Last Update Posted (ACTUAL)

February 3, 2022

Last Update Submitted That Met QC Criteria

February 2, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Anti-VEGF in real-world

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

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