Intravitreal Anti-vascular Endothelial Growth Factor Administration and Its Influence on Vitreomacular Interface- and Retinal Morphology in Eyes With Neovascular Age-related Macular Degeneration

Completed

• Conditions: Vitreomacular Interface

• Registration Number: NCT03680326
• Lead Sponsor: Hospital Hietzing

Brief Summary

Purpose:

To assess the influence of intravitreal anti-vascular endothelial growth factor (anti-VEGF) administration on vitreomacular interface- and retinal morphology in eyes with neovascular age-related macular degeneration (AMD) and to identify morphological markers potentially influencing disease prognosis.

Methods:

43 patients (51 eyes) with treatment naïve neovascular AMD subsequently treated with Bevacizumab 1.25mg (in 0.05ml of solution) were monitored until month 12 of follow-up. Following a loading dose of 3 monthly intravitreal anti-VEGF injections, patients were treated as-needed \[pro re nata (PRN)\]. Functional and morphological changes were assessed using Spectral Domain Optical Coherence Tomography (SD-OCT).

Detailed Description

This retrospective study included 43 treatment-naive patients (51 eyes) with neovascular AMD over the course of 12 months. Patients were treated with a loading dose of 3 initial monthly anti-VEGF injections (Bevacizumab 1.25mg in 0.05ml of solution-Avastin®) and were followed monthly until year 1. Re-treatment was performed if needed (pro re nata-PRN) as previously reported.

Study Timeline

• Study Start: 2015-02-02
• Primary Completion: 2018-03-22
• Study Completion: 2018-04-14
• Status Verified: 2018-09
• Study First Submitted: 2018-09-17
• Study First Submitted QC: 2018-09-19
• Last Update Submitted: 2018-09-19
• Study First Posted: 2018-09-21
• Last Update Posted: 2018-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

• diagnosis of treatment-naive neovascular AMD

Exclusion Criteria

• any treatment with other anti-VEGF agents than Bevacizumab in the follow-up period
• any other diseases leading to macular edema
• prior vitrectomy
• uveitis
• retinal or corneal laser surgery
• high myopia (>6dpt)
• preceding eye trauma

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
visual acuity	12 months	visual acuity testing was performed