Treat-and-extend Using Aflibercept for Type 3 Neovascularization

Sponsor
Kim's Eye Hospital
Study ID
NCT04655482
Phase
PHASE4
Status
Unknown

Conditions

  • Retinal Angiomatous Proliferation

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Aflibercept Injection — DRUG
    Intravitreal injection of aflibercept using treat-and-extend regimen :Three monthly loading injections followed by proactive treatment using TAE regimen. Extension of injection interval by 2 weeks. The maximum injection interval was set as 16 weeks.

Study Details

Type 3 neovascularization is a subtype of neovascular age-related macular degeneration (AMD) that is characterized by intraretinal neovascularization. Treat-and-extend (TAE) regimen is a widely-used, effective anti-vascular endothelial growth factor treatment regimen for neovascular AMD, regardless of subtypes of AMD. The purpose of the present study is to investigate the 18-month treatment outcome of TAE in type 3 neovascularization.

Key Dates

Start date
Feb 1, 2021
Status verified
Aug 2022
Primary completion
Dec 20, 2023
Completion
Aug 20, 2024

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment arm
    Patients treated with aflibercept (2.0ml/0.05cc) using treat-and-extend regimen. Three monthly loading injections followed by proactive treatment using treat-and-extend regimen. Extension of injection interval by 2 weeks. The maximum injection interval was set as 16 weeks.

Primary Outcome Measure

Change in best-corrected visual acuity (BCVA) [ Time Frame: From baseline to week 76 ]

Central Contacts