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

Vitreomacular Interface Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03680326
• Other study ID #: Interface, vitreomacular
• Status: Completed
• Start date: February 2, 2015
• Est. completion date: April 14, 2018

Study information

• Verified date: September 2018
• Source: Hospital Hietzing
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: April 14, 2018
• Est. primary completion date: March 22, 2018
• Gender: All
• Age group: 66 Years to 98 Years

Eligibility

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

Related Conditions & MeSH terms

• Macular Degeneration
• Vitreomacular Interface
• Wet Macular Degeneration

Intervention

Device:
• OCT
only OCT

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Hietzing

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual acuity	visual acuity testing was performed	12 months