Pharmacokinetics Clinical Trial
Official title:
Intraocular Pharmacokinetics of Erythropoietin After Single Intravitreal Injection in Human
The investigators investigate intraocular concentrations and pharmacokinetics of erythropoietin after a single intravitreal injection in humans.
| Status | Recruiting |
| Enrollment | 5 |
| Est. completion date | December 2011 |
| Est. primary completion date | July 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years to 80 Years |
| Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Hallym University Sacred Heart Hoapital | Chuncheon | Kangwondo |
| Lead Sponsor | Collaborator |
|---|---|
| Hallym University Medical Center |
Korea, Republic of,
Lagrèze 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. — View 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. — View 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. — View 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: — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Concentration of erythropoietin in aqueous humor | 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. | a few seconds | Yes |
| Secondary | Concentration of erythropoietin in vitreous | 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. | few minutes | Yes |
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