Erythropoietin, Pharmacokinetics
Conditions
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.
Interventions
PROCEDUREVitrectomy
vitrectomy following intravitreal erythropoietin
Sponsors
Hallym University Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
South Korea
Contacts
Primary ContactJiWon Lim
Outcome results
None listed