Intraocular Pharmacokinetics of Erythropoietin After Single Intravitreal Injection in Human

Hallym University

Status: Unknown

Conditions: Erythropoietin; Pharmacokinetics

Treatments: Procedure: Vitrectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01131533

2010_134

Details and patient eligibility

About

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

Full 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.

Enrollment: 5 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

---

5 participants in 1 patient group

Erythropoietin

Experimental group

Description:

patients with chronic macular edema associated with diabetic retinopathy

Treatment:

Procedure: Vitrectomy