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Use of Eylea for the Treatment of an Optic Nerve Hemangioma

Primary Purpose

Retinal Hemangioma

Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
Aflibercept
Sponsored by
Vitreous -Retina- Macula Consultants of New York
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Retinal Hemangioma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)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

Sites / Locations

  • Vitreous Retina Macula Consultants of New York

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 16, 2012
Last Updated
August 7, 2017
Sponsor
Vitreous -Retina- Macula Consultants of New York
Collaborators
Regeneron Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01714115
Brief Title
Use of Eylea for the Treatment of an Optic Nerve Hemangioma
Official Title
Use of Eylea for the Treatment of an Optic Nerve Hemangioma
Study Type
Expanded Access

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vitreous -Retina- Macula Consultants of New York
Collaborators
Regeneron Pharmaceuticals

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Hemangioma

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Aflibercept
Other Intervention Name(s)
Eylea, VEGF Trap-Eye
Intervention Description
2.0 mg Intravitreal Injection, every 2 to 4 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
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
Facility Information:
Facility Name
Vitreous Retina Macula Consultants of New York
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19222401
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.
Results Reference
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PubMed Identifier
21589848
Citation
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.
Results Reference
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Learn more about this trial

Use of Eylea for the Treatment of an Optic Nerve Hemangioma

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