Intraocular Pharmacokinetics of Erythropoietin After Single Intravitreal Injection in Human

Not Applicable

• Conditions: Pharmacokinetics; Erythropoietin
• Interventions: Procedure: Vitrectomy

• Registration Number: NCT01131533
• Lead Sponsor: Hallym University Medical Center

Brief Summary

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

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.

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2010-05-25
• Study First Submitted QC: 2010-05-26
• Study First Posted: 2010-05-27
• Primary Completion: 2010-07
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-14
• Last Update Posted: 2010-09-15
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Erythropoietin	Vitrectomy	patients with chronic macular edema associated with diabetic retinopathy

Primary Outcome Measures

Name	Time	Method
Concentration of erythropoietin in aqueous humor	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

Name	Time	Method
Concentration of erythropoietin in vitreous	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.

Trial Locations

Locations (1)

Hallym University Sacred Heart Hoapital; 🇰🇷 Chuncheon, Kangwondo, Korea, Republic of