Retinal HemangiomaNCT01714115
Use of Eylea for the Treatment of an Optic Nerve Hemangioma
A study testing Aflibercept in people with Retinal Hemangioma, run by Vitreous -Retina- Macula Consultants of New York at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Retinal Hemangioma
- What is being tested?
- Aflibercept
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Adult, Older adult
Who may be able to join
- retinal hemangioma
- previously treated with conventional therapies, including Avastin, Lucentis, steroid, and photodynamic therapy, with less than ideal results
Who cannot join
- ongoing reevaluation of adverse events, including inflammation, elevated intraocular pressure, or any suspected toxicity from aflibercept
Trial locations and contacts
1 site in 1 country.
United States1 site
Vitreous Retina Macula Consultants of New York
New York, New York, 10022
About this study
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.
Read the 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.
- Conditions
- Retinal Hemangioma
- Being tested
- Aflibercept
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AfliberceptDrug
Also called Eylea, VEGF Trap-Eye
2.0 mg Intravitreal Injection, every 2 to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Retinal HemangiomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Vitreous -Retina- Macula Consultants of New York
- Sponsor type
- University, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01714115
- Sponsor's protocol ID
- Slakter 1234
- Status last verified
- Aug 2017
- First submitted
- 16 Oct 2012
- Last updated
- 8 Aug 2017
- Results posted
- No
Publications
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.
PubMed 19222401Baba 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.
PubMed 21589848
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Eylea for the Treatment of an Optic Nerve Hemangioma
- ClinicalTrials.gov ID
- NCT01714115
- Acronym / sponsor ID
- Slakter 1234
- Conditions
- Retinal Hemangioma
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Vitreous -Retina- Macula Consultants of New YorkUniversity, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- First posted
- 25 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- retinal hemangioma
- previously treated with conventional therapies, including Avastin, Lucentis, steroid, and photodynamic therapy, with less than ideal results
Key exclusion criteria (1 listed)
- ongoing reevaluation of adverse events, including inflammation, elevated intraocular pressure, or any suspected toxicity from aflibercept
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AfliberceptAlso: Eylea, VEGF Trap-Eye2.0 mg Intravitreal Injection, every 2 to 4 weeks | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2017.
- Background: PubMed 19222401Mennel 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.
- Background: PubMed 21589848Baba 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.
Related trials for Retinal Hemangioma
RecruitingPhase 2
Real-World Effectiveness and Pharmacogenetics of Belzutifan in VHL Syndrome: The BELIEVE-VHL Trial
Von Hippel Lindau, Von Hippel Lindau Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aflibercept in people with Retinal Hemangioma, run by Vitreous -Retina- Macula Consultants of New York at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01714115, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2017.