Anti-VEGF in Real-world

Sponsor

Wenbin Wei (Other)

Overall Status

Recruiting

CT.gov ID

NCT05222633

Collaborator

(none)

1,000

Enrollment

Location

15.9

Anticipated Duration (Months)

62.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Neovascular Age-related Macular Edema Diabetic Macular Edema Choroidal Neovascular Membrane Non-proliferative Diabetic Retinopathy Retinal Vein Occlusion Proliferative Diabetic Retinopathy	Drug: Ranibizumab Drug: Aflibercept Drug: Conbercept

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 Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

Visual acuity [1 year]
LogMAR visual acuity
Central subfield thickness [1 year]
he central subfield is defined as the circular area 1 mm in diameter centered around the center point of the fovea

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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