Use of Eylea for the Treatment of an Optic Nerve Hemangioma

• Conditions: Retinal Hemangioma

• Registration Number: NCT01714115
• Lead Sponsor: Vitreous -Retina- Macula Consultants of New York

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2012-10-16
• Study First Submitted QC: 2012-10-22
• Study First Posted: 2012-10-25
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-07
• Last Update Posted: 2017-08-08

Recruitment & Eligibility

• Status: NO_LONGER_AVAILABLE
• Sex: Male
• Target Recruitment: Not specified

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

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified

Trial Locations

Locations (1)

Vitreous Retina Macula Consultants of New York; 🇺🇸 New York, New York, United States