This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Use of Eylea for the Treatment of an Optic Nerve Hemangioma

Expanded access is no longer available for this treatment.
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Vitreous -Retina- Macula Consultants of New York Identifier:
First received: October 16, 2012
Last updated: August 7, 2017
Last verified: August 2017
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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male

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 identifier: NCT01714115

United States, New York
Vitreous Retina Macula Consultants of New York
New York, New York, United States, 10022
Sponsors and Collaborators
Vitreous -Retina- Macula Consultants of New York
Regeneron Pharmaceuticals
  More Information

Responsible Party: Vitreous -Retina- Macula Consultants of New York Identifier: NCT01714115     History of Changes
Other Study ID Numbers: Slakter 1234
Study First Received: October 16, 2012
Last Updated: August 7, 2017

Additional relevant MeSH terms:
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms processed this record on September 19, 2017