NCT02308215

Brief Summary

The main purpose is to find a better way to predict the timing of treatments given to patients with Wet Age-related macular degeneration using image analysis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

July 1, 2010

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

November 13, 2014

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 4, 2014

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2018

Completed
Last Updated

August 30, 2019

Status Verified

August 1, 2019

Enrollment Period

8 years

First QC Date

November 13, 2014

Last Update Submit

August 28, 2019

Conditions

Age-Related Macular DegenerationChoroidal Neovascularization

Keywords

RetinaAMDOCT

Outcome Measures

Primary Outcomes (2)

  • Measure central retinal layer thickness in µms.

    one year

  • Measure amount of fluid in the retina in µms.

    one year

Eligibility Criteria

Age45 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The proposed research will be carried out in patients diagnosed with Choroidal Neovascularization associated with AMD selected from retina care clinic.

You may qualify if:

  • fundoscopically confirmed AMD and patient eligible for treatment with anti-VEGF

You may not qualify if:

  • Patients with a CNV due to other causes (OHS, trauma)
  • eyes that have been previously treated for CNV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Iowa Hospitals Dept of Ophthalmology

Iowa City, Iowa, 52246, United States

Location

MeSH Terms

Conditions

Macular DegenerationChoroidal Neovascularization

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye DiseasesChoroid DiseasesUveal DiseasesNeovascularization, PathologicMetaplasiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Michael D Abramoff, MD, PhD

    University of Iowa

    PRINCIPAL INVESTIGATOR

  • Milan Sonka, MS, PhD

    University of Iowa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 13, 2014

First Posted

December 4, 2014

Study Start

July 1, 2010

Primary Completion

July 5, 2018

Study Completion

July 5, 2018

Last Updated

August 30, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)