NCT01726790

Brief Summary

To evaluate corneal endothelium cell change after intravitreal Bevacizumab injection

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
37

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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, 2011

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 11, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 15, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

November 15, 2012

Status Verified

November 1, 2012

Enrollment Period

1.8 years

First QC Date

November 11, 2012

Last Update Submit

November 11, 2012

Conditions

Corneal Endothelial Cell Loss

Keywords

corneal endotheliumBevacizumabIntravitreal injectionConfoscan

Outcome Measures

Primary Outcomes (1)

  • Corneal endothelium cell change after intravitreal Bevacizumab injection

    Measure the corneal endothelium cell using Confoscan4-Corneal confocal microscope in patient in retinal vascular clinic before and after treat with intravitreal Bevacizumab

    6 months

Secondary Outcomes (1)

  • Assess the complication after intravitreal Bevacizumab injection

    6 month

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient in retinalvascular clinic with diagnosis of retinal vein occlusion with macular edema, diabetic macular edema, wet aged related macular degeneration and submacular hemorrhage)treated with intravitreal Bevacizumab

You may qualify if:

  • aged between 20 and 80 years old
  • can come to regular follow up at 6 month
  • signed written consent forms
  • not have corneal scar, or glaucoma
  • history of treatment with laser or anti-VEGF therapy in 3 month prior to recruit
  • high risk in cerebrovascular and cardiovascular diseases
  • Pregnancy and breastfeeding
  • can undergo confocal microspopy

You may not qualify if:

  • History of intraocular surgery or ocular trauma during study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KKU eye center, department of Ophthalmolgy, faculty of medicine, khon kaen university

Khon Kaen, Changwat Khon Kaen, 4002, Thailand

RECRUITING

MeSH Terms

Conditions

Corneal Endothelial Cell Loss

Condition Hierarchy (Ancestors)

Corneal DiseasesEye DiseasesEye ManifestationsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Central Study Contacts

Kasem Yospaiboon, MD

CONTACT

66823057231kasem_yod@hotmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Kasem Yospaiboon, MD

Study Record Dates

First Submitted

November 11, 2012

First Posted

November 15, 2012

Study Start

August 1, 2011

Primary Completion

June 1, 2013

Study Completion

October 1, 2013

Last Updated

November 15, 2012

Record last verified: 2012-11

Locations

TH(1)