Use of Eylea for the Treatment of an Optic Nerve Hemangioma

Vitreous -Retina- Macula Consultants of New York

Status

Conditions: Retinal Hemangioma

Treatments: Drug: Aflibercept

Study type: Expanded Access

Funder types: Other; Industry

Identifiers

NCT01714115

Slakter 1234

Details and patient eligibility

About

This is a single patient investigative treatment study. The patient was diagnosed with a retinal tumor in one eye. In the last 2 years, the patient has been treated with all available and conventional therapies, including intraocular injections of Avastin and Lucentis, steroids, and photodynamic therapy. Any positive results were short-term, and caused an eventual decline in central vision. Aflibercept has been shown to be effective against the growth of new vessels, secondary to macular degeneration. This study proposes that it may also be more effective in treating this particular patient and case. The study treatment plan is for 6 months initially, with the intention to continue treatment.

Full description

The treatment plan will be to administer aflibercept 2.0 mg intravitreally every two to four weeks for at least six consecutive injections. Prior to initiation of therapy and at each study visit, a full ophthalmic examination, best-corrected visual acuity, and a complete review of systems to monitor for any toxicity will be performed. In addition, the investigators will perform fluorescein and indocyanine green angiography at baseline and obtain color fundus photographs as well as spectral domain OCT images to properly document the extent and degree of activity of the vascular tumor at baseline and at all study visits.

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• retinal hemangioma
• previously treated with conventional therapies, including Avastin, Lucentis, steroid, and photodynamic therapy, with less than ideal results

Exclusion criteria

• ongoing reevaluation of adverse events, including inflammation, elevated intraocular pressure, or any suspected toxicity from aflibercept