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Analysis of Angiogenic Factor Levels in Eyes With Diabetic Retinopathy

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ClinicalTrials.gov Identifier: NCT02026843
Recruitment Status : Recruiting
First Posted : January 3, 2014
Last Update Posted : August 30, 2016
Sponsor:
Information provided by (Responsible Party):
Dong Ho Park, Kyungpook National University

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


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.



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.
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT02026843


Contacts
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Contact: Dong Ho Park, M.D. 82-53-420-5813 sarasate2222@gmail.com

Locations
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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    sarasate2222@gmail.com   
Sponsors and Collaborators
Kyungpook National University
Investigators
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Principal Investigator: Dong Ho Park, M.D Kyungpook National University

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Responsible Party: Dong Ho Park, Department of Opthalmology, School of medicine, Kyungpook National University, Kyungpook National University
ClinicalTrials.gov Identifier: NCT02026843     History of Changes
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