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Analysis of Angiogenic Factor Levels in Eyes With Diabetic Retinopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02026843
Recruitment Status : Recruiting
First Posted : January 3, 2014
Last Update Posted : August 30, 2016
Information provided by (Responsible Party):
Dong Ho Park, Kyungpook National University Hospital

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

Condition or disease
Diabetic Retinopathy

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Analysis of Angiogenic Protein and Anti-angiogenic Levels in Eyes With Diabetic Retinopathy.
Study Start Date : April 2012
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. 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.

Biospecimen Retention:   Samples Without DNA
certain protein levels in aqueus humor

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02026843

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Contact: Dong Ho Park, M.D. 82-53-420-5813

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Korea, Republic of
Dong Ho Park Recruiting
Daegu, Kyungsangpookdo, Korea, Republic of, 700-721
Contact: Dong Ho Park, M.D    82-53-420-5813   
Sponsors and Collaborators
Kyungpook National University Hospital
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Principal Investigator: Dong Ho Park, M.D Kyungpook National University Hospital

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Responsible Party: Dong Ho Park, Department of Opthalmology, School of medicine, Kyungpook National University, Kyungpook National University Hospital Identifier: NCT02026843    
Other Study ID Numbers: KNUH2013-1
First Posted: January 3, 2014    Key Record Dates
Last Update Posted: August 30, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases