Use of Eylea for the Treatment of an Optic Nerve Hemangioma

Retinal Hemangioma Clinical Trial

Official title:

Use of Eylea for the Treatment of an Optic Nerve Hemangioma

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT01714115
• Other study ID #: Slakter 1234
• Status: No longer available
• Phase: N/A
• First received: October 16, 2012
• Last updated: August 7, 2017

Study information

• Verified date: August 2017
• Source: Vitreous -Retina- Macula Consultants of New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemangioma
• Retinal Hemangioma

Intervention

Drug:
• Aflibercept
2.0 mg Intravitreal Injection, every 2 to 4 weeks

Locations

Country	Name	City	State
United States	Vitreous Retina Macula Consultants of New York	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Vitreous -Retina- Macula Consultants of New York	Regeneron Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation