NCT03680326

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2015

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 2, 2015

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2018

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 21, 2018

Completed
Last Updated

September 21, 2018

Status Verified

September 1, 2018

Enrollment Period

3.1 years

First QC Date

September 17, 2018

Last Update Submit

September 19, 2018

Conditions

Vitreomacular Interface

Outcome Measures

Primary Outcomes (1)

  • visual acuity

    visual acuity testing was performed

    12 months

Study Arms (1)

OCT

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

Device: OCT

Interventions

OCTDEVICE

only OCT

OCT

Eligibility Criteria

Age66 Years - 98 Years
Sexall
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

treatment-naive patients with neovascular AMD

You may qualify if:

  • \- diagnosis of treatment-naive neovascular AMD

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

September 17, 2018

First Posted

September 21, 2018

Study Start

February 2, 2015

Primary Completion

March 22, 2018

Study Completion

April 14, 2018

Last Updated

September 21, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share