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Intraocular Pharmacokinetics of Erythropoietin After Single Intravitreal Injection in Human

Information source: Hallym University Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pharmacokinetics; Erythropoietin

Intervention: Vitrectomy (Procedure)

Phase: N/A

Status: Recruiting

Sponsored by: Hallym University Medical Center

Overall contact:
JiWon Lim, Phone: 82-33-240-5176, Email: jiwoneye@hallym.or.kr

Summary

The investigators investigate intraocular concentrations and pharmacokinetics of erythropoietin after a single intravitreal injection in humans.

Clinical Details

Official title: Intraocular Pharmacokinetics of Erythropoietin After Single Intravitreal Injection in Human

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Primary outcome: Concentration of erythropoietin in aqueous humor

Secondary outcome: Concentration of erythropoietin in vitreous

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

Minimum age: 20 Years. Maximum age: 80 Years. Gender(s): Both.

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

Locations and Contacts

JiWon Lim, Phone: 82-33-240-5176, Email: jiwoneye@hallym.or.kr

Hallym University Sacred Heart Hoapital, Chuncheon, Kangwondo 200-704, Korea, Republic of; Recruiting
JiWon Lim, Phone: 82-33-240-5176, Email: jiwoneye@hallym.or.kr
Additional Information

Starting date: January 2009
Last updated: September 14, 2010

Page last updated: August 23, 2015

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