Use of Eylea for the Treatment of an Optic Nerve Hemangioma

NCT ID: NCT01714115

Last Updated: 2017-08-08

Basic Information

• Recruitment Status: NO_LONGER_AVAILABLE
• Study Classification: EXPANDED_ACCESS

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.

Conditions

Retinal Hemangioma

Interventions

Aflibercept

2.0 mg Intravitreal Injection, every 2 to 4 weeks

Intervention Type: DRUG

Other Intervention Names

Eylea, VEGF Trap-Eye

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Vitreous -Retina- Macula Consultants of New York

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Vitreous Retina Macula Consultants of New York

New York, New York, United States

Countries

United States

References

Mennel S, Meyer CH, Callizo J. Combined intravitreal anti-vascular endothelial growth factor (Avastin) and photodynamic therapy to treat retinal juxtapapillary capillary haemangioma. Acta Ophthalmol. 2010 Aug;88(5):610-3. doi: 10.1111/j.1755-3768.2008.01449.x. Epub 2009 Feb 12.

Reference Type: BACKGROUND

PMID: 19222401 (View on PubMed)

Baba T, Kitahashi M, Kubota-Taniai M, Oshitari T, Yamamoto S. Subretinal hemorrhage after photodynamic therapy for juxtapapillary retinal capillary hemangioma. Case Rep Ophthalmol. 2011 Apr 22;2(1):134-9. doi: 10.1159/000328384.

Reference Type: BACKGROUND

PMID: 21589848 (View on PubMed)

Other Identifiers

Slakter 1234

Identifier Type: -

Identifier Source: org_study_id