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Intraocular Pharmacokinetics of Erythropoietin After Single Intravitreal Injection in Human

NCT ID: NCT01131533

Last Updated: 2010-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Pharmacokinetics Erythropoietin

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Erythropoietin

patients with chronic macular edema associated with diabetic retinopathy

Group Type EXPERIMENTAL

Vitrectomy

Intervention Type PROCEDURE

vitrectomy following intravitreal erythropoietin

Interventions

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Vitrectomy

vitrectomy following intravitreal erythropoietin

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hallym University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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department of ophthalmology

Locations

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Hallym University Sacred Heart Hoapital

Chuncheon, Kangwondo, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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JiWon Lim

Role: CONTACT

[email protected]
82-33-240-5176

Facility Contacts

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JiWon Lim

Role: primary

[email protected]
82-33-240-5176

References

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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. doi: 10.3928/15428877-20091230-03.

Reference Type RESULT
PMID: 20128565 (View on PubMed)

Lagreze WA, Feltgen N, Bach M, Jehle T. Feasibility of intravitreal erythropoietin injections in humans. Br J Ophthalmol. 2009 Dec;93(12):1667-71. doi: 10.1136/bjo.2008.156794. Epub 2009 Aug 18.

Reference Type RESULT
PMID: 19692373 (View on PubMed)

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. doi: 10.1080/02713680802366602.

Reference Type RESULT
PMID: 18798078 (View on PubMed)

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. doi: 10.1167/iovs.07-0721.

Reference Type RESULT
PMID: 18235022 (View on PubMed)

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 Exp Ophthalmol. 2011 Aug;39(6):537-44. doi: 10.1111/j.1442-9071.2011.02510.x. Epub 2011 Mar 24.

Reference Type DERIVED
PMID: 21819507 (View on PubMed)

Other Identifiers

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2010_134

Identifier Type: -

Identifier Source: org_study_id