NCT01579760

Intravitreal Aflibercept Injection for Radiation Retinopathy

Treatment of Radiation Retinopathy With Intravitreal Aflibercept Injection 2.0mg

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety of intravitreal aflibercept injection - in the treatment of macular edema associated with retinopathy secondary to previous radiation therapy.

Detailed description

Radiation retinopathy can cause decreased vision in patients who have received either external beam radiation or local plaque therapy to the eye. An early manifestation of radiation retinopathy is macular edema, which represents fluid within the retina that affects central vision. There is currently no approved treatment for this disease, although there have been anecdotal reports of benefit with laser photocoagulation, intravitreal anti-VEGF agents, or intravitreal steroid use. This is a phase 1 study to evaluate aflibercept for the treatment of macular edema associated with retinopathy secondary to previous radiation treatment.

Conditions

• Radiation Retinopathy
• Macular Edema

Interventions

Type	Name	Description
DRUG	Aflibercept every 2 months	2.0 mg aflibercept intravitreal injections once per month for the first 3 months (M0, M1, M2), then every 2 months (M4, M6, M8, M10)
DRUG	Aflibercept monthly	2.0mg aflibercept intravitreal injections every month (M0-11)

Timeline

• Start date: 2012-11-01
• Primary completion: 2019-01-01
• Completion: 2019-03-27
• First posted: 2012-04-18
• Last updated: 2019-04-25

Locations

2 sites across 1 country: United States