Clinical trial NCT01131533: Intraocular Pharmacokinetics of Erythropoietin After Single Intravitreal Injection in Human
Official title: Intraocular Pharmacokinetics of Erythropoietin After Single Intravitreal Injection in Human
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pharmacokinetics
Erythropoietin
Lead sponsor: Hallym University Medical Center
Sponsor class: OTHER
First posted: 2010-05-27
Enrollment: 5
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Concentration of erythropoietin in aqueous humor
timeFrame: a few seconds
Secondary outcomes:
measure: Concentration of erythropoietin in vitreous
timeFrame: few minutes
Other outcomes:
Locations:
city: Chuncheon
country: Korea, Republic of
facility: Hallym University Sacred Heart Hoapital
state: Kangwondo
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.