NCT01714115

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 25, 2012

Completed
Last Updated

August 8, 2017

Status Verified

August 1, 2017

First QC Date

October 16, 2012

Last Update Submit

August 7, 2017

Conditions

Interventions

2.0 mg Intravitreal Injection, every 2 to 4 weeks

Also known as: Eylea, VEGF Trap-Eye

Eligibility Criteria

Age18 Years+
Sexmale
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • retinal hemangioma
  • previously treated with conventional therapies, including Avastin, Lucentis, steroid, and photodynamic therapy, with less than ideal results

You may not qualify if:

  • ongoing reevaluation of adverse events, including inflammation, elevated intraocular pressure, or any suspected toxicity from aflibercept

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vitreous Retina Macula Consultants of New York

New York, New York, 10022, United States

Location

Related Publications (2)

  • 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.

    PMID: 19222401BACKGROUND
  • 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.

    PMID: 21589848BACKGROUND

MeSH Terms

Interventions

aflibercept

Study Design

Study Type
expanded access
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2012

First Posted

October 25, 2012

Last Updated

August 8, 2017

Record last verified: 2017-08

Locations