Use of Eylea for the Treatment of an Optic Nerve Hemangioma

Expanded access is currently available for this treatment.
Verified June 2013 by Vitreous -Retina- Macula Consultants of New York
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Vitreous -Retina- Macula Consultants of New York
ClinicalTrials.gov Identifier:
NCT01714115
First received: October 16, 2012
Last updated: June 11, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Retinal Hemangioma
Drug: Aflibercept

Study Type: Expanded Access     What is Expanded Access?
Official Title: Use of Eylea for the Treatment of an Optic Nerve Hemangioma

Resource links provided by NLM:


Further study details as provided by Vitreous -Retina- Macula Consultants of New York:

Intervention Details:
    Drug: Aflibercept
    2.0 mg Intravitreal Injection, every 2 to 4 weeks
    Other Name: Eylea, VEGF Trap-Eye
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01714115

Contacts
Contact: May Lee, BA, MST 212-452-6965 MLee@vrmny.com

Locations
United States, New York
Vitreous Retina Macula Consultants of New York
New York, New York, United States, 10022
Contact: May Lee, BA, MST    212-452-6965    MLee@vrmny.com   
Principal Investigator: Jason S Slakter, MD         
Sponsors and Collaborators
Vitreous -Retina- Macula Consultants of New York
Regeneron Pharmaceuticals
  More Information

Publications:
Responsible Party: Vitreous -Retina- Macula Consultants of New York
ClinicalTrials.gov Identifier: NCT01714115     History of Changes
Other Study ID Numbers: Slakter 1234
Study First Received: October 16, 2012
Last Updated: June 11, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hemangioma
Eye Neoplasms
Retinal Diseases
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Eye Diseases

ClinicalTrials.gov processed this record on August 28, 2014