Analysis of Angiogenic Factor Levels in Eyes With Diabetic Retinopathy

February 17, 2021 updated by: Dong Ho Park, Kyungpook National University Hospital

Analysis of Angiogenic Protein and Anti-angiogenic Levels in Eyes With Diabetic Retinopathy.

This study was conducted to investigate the levels of angiogenic factors and anti-angiogenic factors in the aqueous humor of patients with diabetic retinopathy.

Study Overview

Status

Unknown

Conditions

Detailed Description

This prospective, case-control study included 50 patients(50eyes) with severe nonproliferative diabetic retinopathy or proliferative diabetic retinopathy and 50 patient with nondiabetic retinopathy or cataract. Aqueous humor was taken before injection of anti-vascular endothelial growth factor agent or pars plana vitrectomy for other retinal disease. Angiogenic and non-angiogenic proteins were analyzed.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

A total of 100 patients will be included. 50 patients with diabetic retinopathy scheduled for intravitreal bevacizumab injection or phacoemulsification and 50 control patients scheduled for pars plana vitrectomy for nondiabetic retinal disease or phacoemulsification.

Description

Inclusion Criteria:

  • age over 20 years
  • diabetic patients requiring opthalmologic treatments for different degrees of decreasing of visual acuity.
  • diabetic patients requiring intravitreal injection,cataract surgery or vitrectomy
  • nondiabetic patients asking cataract surgery or vitrectomy for posterior segment nonproliferative disorders.

Exclusion Criteria:

  • under the age of 20 years
  • patients that received any anti-vascular endothelial growth factor agent for proliferative disease before taking sample of aqueous humor
  • patients that did not signed the informed consent of the trial
  • patients with intraocular inflammations or infections that requiring any pharmaceutical agent
  • patients with recent ocular trauma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Diabetic retinopathy,humor,angiogenic
Samples of aqueous humor was taken before injection and before surgery. The injection include bevacizumab or triamcinolone.
Nondiabetic,angiogenic,humor
Aqueous humor was taken before surgery. Surgery include pars plana vitrectomy of macular hole, epiretinal membrane, cataract surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aqueous secretory angiogenic and anti-angiogenic protein concentration
Time Frame: one month
To establish if certain type of diabetic retinopathy and nondiabetic retinal disease group are associated to different concentrations of angiogenic or anti-angiogenic protein concentration.
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyungpook National University Hospital

Investigators

  • Principal Investigator: Dong Ho Park, M.D, Kyungpook National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Anticipated)

February 1, 2022

Study Completion (Anticipated)

April 1, 2022

Study Registration Dates

First Submitted

December 29, 2013

First Submitted That Met QC Criteria

December 31, 2013

First Posted (Estimate)

January 3, 2014

Study Record Updates

Last Update Posted (Actual)

February 18, 2021

Last Update Submitted That Met QC Criteria

February 17, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KNUH2013-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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