Anti-VEGF in Real-world

• Conditions: Neovascular Age-related Macular Edema; Proliferative Diabetic Retinopathy; Diabetic Macular Edema; Choroidal Neovascular Membrane; Non-proliferative Diabetic Retinopathy; Retinal Vein Occlusion
• Interventions: Drug: Ranibizumab; Drug: Aflibercept; Drug: Conbercept

• Registration Number: NCT05222633
• Lead Sponsor: Wenbin Wei

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.

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 Timeline

• Study First Submitted: 2021-12-25
• Study Start: 2022-01-01
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-02
• Last Update Submitted: 2022-02-02
• Study First Posted: 2022-02-03
• Last Update Posted: 2022-02-03
• Primary Completion: 2023-01-01
• Study Completion: 2023-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Neovascular age-related macular edema	Ranibizumab	Patients with new-onset and recurrent Neovascular age-related macular edema.
Neovascular age-related macular edema	Conbercept	Patients with new-onset and recurrent Neovascular age-related macular edema.
Neovascular age-related macular edema	Aflibercept	Patients with new-onset and recurrent Neovascular age-related macular edema.
Diabetic macula edema	Ranibizumab	Patients with new-onset and recurrent diabetic macula edema
Diabetic macula edema	Aflibercept	Patients with new-onset and recurrent diabetic macula edema
Diabetic macula edema	Conbercept	Patients with new-onset and recurrent diabetic macula edema
Non-proliferative diabetic retinopathy/proliferative diabetic retinopathy	Ranibizumab	Patients with new-onset and recurrent non-proliferative diabetic retinopathy/proliferative diabetic retinopathy
Non-proliferative diabetic retinopathy/proliferative diabetic retinopathy	Aflibercept	Patients with new-onset and recurrent non-proliferative diabetic retinopathy/proliferative diabetic retinopathy
Choroidal neovascularization	Ranibizumab	Patients with new-onset and recurrent choroidal neovascularization
Non-proliferative diabetic retinopathy/proliferative diabetic retinopathy	Conbercept	Patients with new-onset and recurrent non-proliferative diabetic retinopathy/proliferative diabetic retinopathy
Retinal vein occlusions	Ranibizumab	Patients with new-onset and recurrent retinal vein occlusions
Choroidal neovascularization	Aflibercept	Patients with new-onset and recurrent choroidal neovascularization
Choroidal neovascularization	Conbercept	Patients with new-onset and recurrent choroidal neovascularization

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Wen-Bin Wei; 🇨🇳 Beijing, Beijing, China