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

NCT ID: NCT03680326

Last Updated: 2018-09-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 43 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-02-02
• Study Completion Date: 2018-04-14

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.

Conditions

Vitreomacular Interface

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Study Groups

OCT

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

OCT

Intervention Type: DEVICE

only OCT

Interventions

OCT

only OCT

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 66 Years
• Maximum Eligible Age: 98 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Hietzing

OTHER

Sponsor Role: lead

Responsible Party

Dr. Clara Wernigg

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Interface, vitreomacular

Identifier Type: -

Identifier Source: org_study_id