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CompletedNCT03680326Updated Sep 21, 2018

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

An observational study in Vitreomacular Interface, sponsored by Hospital Hietzing. Completed. Open to participants aged 66 Years to 98 Years. Per ClinicalTrials.gov, last updated 2018-09-21.

Sponsored by Hospital Hietzing · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
43
Ages
66 Years to 98 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Vitreomacular Interface
03

In context

Lead sponsor

Hospital Hietzing is the lead sponsor of 15 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
66 Years to 98 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

treatment-naive patients with neovascular AMD

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • diagnosis of treatment-naive neovascular AMD

Exclusion criteria

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
05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
43 participants (actual)
Patient registry
No

Groups and cohorts

  • OCT

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

    Device: OCT

Interventions

  • DeviceOCT

    only OCT

06

What researchers measure

Primary outcomes

  1. visual acuity

    visual acuity testing was performed

    Time frame: 12 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2015 to primary completion in Mar 2018, 37 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 17, 2018
First posted
Sep 21, 2018
StartActual
Feb 2, 2015
Primary completionActual
Mar 22, 2018
CompletionActual
Apr 14, 2018
Last update
Sep 21, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 21, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03680326
Lead sponsor
Hospital Hietzing
Responsible party
Dr. Clara Wernigg (Dr., Hospital Hietzing) — Principal investigator
First posted
Sep 21, 2018
Start date
Feb 2, 2015
Primary completion
Mar 22, 2018
Completion
Apr 14, 2018
Last update
Sep 21, 2018

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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