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Use of Eylea for the Treatment of an Optic Nerve Hemangioma

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ClinicalTrials.gov Identifier: NCT01714115
Recruitment Status : No longer available
First Posted : October 25, 2012
Last Update Posted : August 8, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Retinal Hemangioma Drug: Aflibercept

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 Design

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birthmarks Eye Care
Drug Information available for: Aflibercept
U.S. FDA Resources

Interventions

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

Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01714115


Locations
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