Anti-VEGF in Real-world

Diabetic Macular Edema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05222633
• Other study ID #: Anti-VEGF in real-world
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: May 1, 2023

Study information

• Verified date: February 2022
• Source: Beijing Tongren Hospital
• Contact: Wenbin Wei, MD
• Phone: 010-58269523
• Email: weiwenbintr[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: May 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Choroidal Neovascular Membrane
• Diabetic Macular Edema
• Diabetic Retinopathy
• Edema
• Macular Edema
• Non-proliferative Diabetic Retinopathy
• Proliferative Diabetic Retinopathy
• Retinal Diseases
• Retinal Vein Occlusion

Intervention

Drug:
• Ranibizumab
Ranibizumab 0.5mg/0.05ml intravitreal injection
• Aflibercept
Aflibercept 2.0mg/0.05ml intravitreal injection
• Conbercept
Conbercept 0.5mg/0.05ml intravitreal injection

Locations

Country	Name	City	State
China	Wen-Bin Wei	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Wenbin Wei

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual acuity	LogMAR visual acuity	1 year
Primary	Central subfield thickness	he central subfield is defined as the circular area 1 mm in diameter centered around the center point of the fovea	1 year