NCT01792154

Brief Summary

Assess changes in the corneal cell count using Specular Microscopy following tretments with Anti-VEGF injections

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2012

Shorter than P25 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

August 1, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 15, 2013

Completed
Last Updated

February 15, 2013

Status Verified

February 1, 2013

Enrollment Period

3 months

First QC Date

February 11, 2013

Last Update Submit

February 12, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • Specular Photomicrographic Assessment of the Effect of Anti-VEGF Intravitreal injections on corneal thickness and endothelial cell density and morphology

    Changes in corneal endothelial cell density and corneal thickness measured by changes in pachymetry and corneal cell count.

    Baseline, Month 6 and Month 12

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects of either gender with an age greater than 50 years of age who have been receiving intraocular Anti-VEGF medication every month for at least the past 3 months.

You may qualify if:

  • Wet Age-related Macular Degeneration
  • Receiving monthly intraocular injections of Anti-VEGF medication for at least 3 months
  • Age greater than 50 years of age

You may not qualify if:

  • experiences adverse events

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Retina Institute of Hawaii

Honolulu, Hawaii, 96815, United States

Location

MeSH Terms

Conditions

Retinal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • Michael D Bennett, MD

    Retina Institute of Hawaii

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2013

First Posted

February 15, 2013

Study Start

August 1, 2012

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

February 15, 2013

Record last verified: 2013-02

Locations