Intraocular Pharmacokinetics of Erythropoietin After Single Intravitreal Injection in Human

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2010 by Hallym University Medical Center.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Hallym University Medical Center

ClinicalTrials.gov Identifier:

NCT01131533

First received: May 25, 2010

Last updated: September 14, 2010

Last verified: September 2010

History of Changes

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 Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment
Official Title:	Intraocular Pharmacokinetics of Erythropoietin After Single Intravitreal Injection in Human

Resource links provided by NLM:

Drug Information available for: Erythropoietin Epoetin Alfa

U.S. FDA Resources

Further study details as provided by Hallym University Medical Center:

Primary Outcome Measures:

Concentration of erythropoietin in aqueous humor [ Time Frame: a few seconds ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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

Ages Eligible for Study:	20 Years to 80 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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:

Li W, Sinclair SH, Xu GT. Effects of intravitreal erythropoietin therapy for patients with chronic and progressive diabetic macular edema. Ophthalmic Surg Lasers Imaging. 2010 Jan-Feb;41(1):18-25.

Lagrèze WA, Feltgen N, Bach M, Jehle T. Feasibility of intravitreal erythropoietin injections in humans. Br J Ophthalmol. 2009 Dec;93(12):1667-71. Epub 2009 Aug 18.

Song BJ, Cai H, Tsai JC, Chang S, Forbes M, Del Priore LV. Intravitreal recombinant human erythropoietin: a safety study in rabbits. Curr Eye Res. 2008 Sep;33(9):750-60.

Zhang J, Wu Y, Jin Y, Ji F, Sinclair SH, Luo Y, Xu G, Lu L, Dai W, Yanoff M, Li W, Xu GT. Intravitreal injection of erythropoietin protects both retinal vascular and neuronal cells in early diabetes. Invest Ophthalmol Vis Sci. 2008 Feb;49(2):732-42.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lim JW, Han JR. Aqueous humour levels of vascular endothelial growth factor and erythropoietin in patients with diabetic macular oedema before and after intravitreal erythropoietin injection. Clin Experiment Ophthalmol. 2011 Aug;39(6):537-44. Epub 2011 Mar 24.

Responsible Party:	hallym unuversity medical center, department of ophthalmology
ClinicalTrials.gov Identifier:	NCT01131533 History of Changes
Other Study ID Numbers:	2010_134
Study First Received:	May 25, 2010
Last Updated:	September 14, 2010
Health Authority:	South Korea: Institutional Review Board

Additional relevant MeSH terms:

Epoetin Alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013

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