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
|