Intraocular Pharmacokinetics of Erythropoietin After Single Intravitreal Injection in Human

Sponsor

Hallym University Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT01131533

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pharmacokinetics Erythropoietin	Procedure: Vitrectomy	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

5 participants

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

Study Start Date :

Jan 1, 2009

Actual Primary Completion Date :

Jul 1, 2010

Anticipated Study Completion Date :

Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Erythropoietin patients with chronic macular edema associated with diabetic retinopathy	Procedure: Vitrectomy vitrectomy following intravitreal erythropoietin

Arm

Intervention/Treatment

Experimental: Erythropoietin

patients with chronic macular edema associated with diabetic retinopathy

Procedure: Vitrectomy

vitrectomy following intravitreal erythropoietin

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Hallym University Sacred Heart Hoapital	Chuncheon	Kangwondo	Korea, Republic of	200-704

Sponsors and Collaborators

Hallym University Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01131533

Other Study ID Numbers:

2010_134

First Posted:

May 27, 2010

Last Update Posted:

Sep 15, 2010

Last Verified:

Sep 1, 2010

Study Results

No Results Posted as of Sep 15, 2010