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

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

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).

Study Overview

• Status: Completed
• Conditions: Vitreomacular Interface
• Intervention / Treatment: Device: 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 Type: Observational
• Enrollment (Actual): 43

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 66 years to 98 years (Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

treatment-naive patients with neovascular AMD

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
OCT; only optical coherence tomography and visual acuity testing at each visit, patients were recruited retrospectively, only data analysis	Device: OCT; only OCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual acuity	visual acuity testing was performed	12 months

Collaborators and Investigators

• Sponsor: Hospital Hietzing

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2015
• Primary Completion (Actual): March 22, 2018
• Study Completion (Actual): April 14, 2018

Study Registration Dates

• First Submitted: September 17, 2018
• First Submitted That Met QC Criteria: September 19, 2018
• First Posted (Actual): September 21, 2018

Study Record Updates

• Last Update Posted (Actual): September 21, 2018
• Last Update Submitted That Met QC Criteria: September 19, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration
• Other Study ID Numbers: Interface, vitreomacular

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No