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Intraocular Pharmacokinetics of Erythropoietin After Single Intravitreal Injection in Human

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2010 by Hallym University Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01131533
First Posted: May 27, 2010
Last Update Posted: September 15, 2010
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. Read our disclaimer for details.
Information provided by:
Hallym University Medical Center
  Purpose
The investigators investigate intraocular concentrations and pharmacokinetics of erythropoietin after a single intravitreal injection in humans.

Condition Intervention
Pharmacokinetics Erythropoietin Procedure: Vitrectomy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Intraocular Pharmacokinetics of Erythropoietin After Single Intravitreal Injection in Human

Resource links provided by NLM:


Further study details as provided by Hallym University Medical Center:

Primary Outcome Measures:
  • Concentration of erythropoietin in aqueous humor [ Time Frame: a few seconds ]
    erythropoietin injections had been performed in our department following standard procedures. In selected cases,vitrectomy was performed one to two days after erythropoietin injection to treat diabetic macular edema.During surgery, aqueous humor samples were obtained via a corneal paracentesis anterior to the limbus at the beginning of the procedure.


Secondary Outcome Measures:
  • Concentration of erythropoietin in vitreous [ Time Frame: few minutes ]
    erythropoietin injections had been performed in our department following standard procedures. In selected cases,vitrectomy was performed one to two days after erythropoietin injection to treat diabetic macular edema.During surgery, vitreous samples were obtained via vitreous cutter at the beginning of the procedure.


Estimated Enrollment: 5
Study Start Date: January 2009
Estimated Study Completion Date: December 2011
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Erythropoietin
patients with chronic macular edema associated with diabetic retinopathy
Procedure: Vitrectomy
vitrectomy following intravitreal erythropoietin

Detailed Description:
Intravitreal injections of erythropoietin for off-label use have been shown to be beneficial in eyes with diabetic macular edema.However, the pharmacokinetic profile of erythropoietin after intravitreal injection in humans has not yet been determined clearly. The purpose of this study was to determine the intraocular pharmacokinetics of erythropoietin after a single intravitreal injection in a prospective investigation.
  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • diabetic macular edema that failed to respond to or recurred after the previous macular focal laser photocoagulation or intravitreal therapy, or both.
  • visual acuity worse than 40/200 snellen bisual acuity

Exclusion Criteria:

  • Eyes with vitreomacular traction, active proliferative diabetic retinopathy, intraocular inflammation, uncontrolled intraocular pressure , cataract surgery within the past six months, or a prior history of vitreoretinal surgery
  Contacts and Locations
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): NCT01131533


Contacts
Contact: JiWon Lim 82-33-240-5176 jiwoneye@hallym.or.kr

Locations
Korea, Republic of
Hallym University Sacred Heart Hoapital Recruiting
Chuncheon, Kangwondo, Korea, Republic of, 200-704
Contact: JiWon Lim    82-33-240-5176    jiwoneye@hallym.or.kr   
Sponsors and Collaborators
Hallym University Medical Center
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: hallym unuversity medical center, department of ophthalmology
ClinicalTrials.gov Identifier: NCT01131533     History of Changes
Other Study ID Numbers: 2010_134
First Submitted: May 25, 2010
First Posted: May 27, 2010
Last Update Posted: September 15, 2010
Last Verified: September 2010

Additional relevant MeSH terms:
Epoetin Alfa
Hematinics