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
• Interventions: Device: OCT

• 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

Arm && Interventions

Group	Intervention	Description
OCT	OCT	only optical coherence tomography and visual acuity testing at each visit, patients were recruited retrospectively, only data analysis

Primary Outcome Measures

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