Exudative Age-related Macular DegenerationNCT01526070
Study of Bimonthly VEGF Trap-Eye Compared to As-needed Administration or Other Therapy for Exudative Age-Related Macular Degeneration
An observational study of Exudative Age-related Macular Degeneration, run by Stanford University at 1 site in United States.
Trial summary
Over the last several years, the standard of care for wet macular degeneration has become treatment with intravitreal injections of ranibizumab (Lucentis, Genentech), administered as frequently as every 4 weeks. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Exudative Age-related Macular Degeneration
- What is being tested?
- Intravitreal injection of Aflibercept
- Type of treatment
- Injection or infusion
- How many people
- 142 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Jul 2014
- Phase
- Observational
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with exudative age-related macular degeneration
Who may be able to join
- Patients older than the age of 50 determined by a retinal physician at the Byers Eye Institute at Stanford to have exudative AMD requiring treatment.
- Patients with an established diagnosis of exudative AMD who have been maintained on a regimen of intravitreal ranibizumab injections.
- Postmenopausal or negative pregnancy test
- Patients with an established diagnois of exidative AMD who have been switched from intravitreal ranibizumab to intravitreal VEGF Trap-EYE.
Who cannot join
- Patients with any previous or concurrent history of treatment of other retinal diseases with pharmacologic agents other than ranibizumab, including verteporfin photodynamic therapy, bevacizumab, triamcinolone, or dexamethasone.
- Patients with prior history of vitrectomy surgery in the study eye.
- Patients enrolled in any previous or current clinical trial or study of any medication for AMD or any other retinal vascular disease, including diabetic retinopathy or retinal vein occlusion.
- Ocular media opacity precluding proper retinal imaging
- Inadequate pupillary dilation to achieve proper retinal imaging
- Concurrent use of systemic anti-VEGF agents
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- CNV due to other causes, including histoplasmosis, uveitis, trauma, or myopia
- Active or recent (< 4 weeks) or recurrent inflammation in the eye
- Current vitreous hemorrhage in the study eye limiting visualization of the fundus
- Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis
- Untreated glaucoma with IOP > 25 in the eye
- Other ocular diseases that can compromise the visual acuity of the study eye such as amblyopia and anterior ischemic optic neuropathy
- Pregnancy or lactation
- History of other disease, exam finding, or clinical laboratory that contraindicates the use the drug
- Current treatment for active systemic infection
- Evidence of significant uncontrolled concomitant diseases such as cardiovascular disease, pulmonary, renal, hepatic, endocrine, or GI disorders
- History of recurrent significant infections or bacterial infections
- Inability to comply with study or follow-up procedure
Trial locations and contacts
1 site in 1 country.
United States1 site
Byers Eye Institute at Stanford
Palo Alto, California, 94303
About this study
Official title: Bimonthly VEGF Trap-Eye Compared to As-needed Administration or Standard Therapy for Exudative Age-Related Macular Degeneration
Over the last several years, the standard of care for wet macular degeneration has become treatment with intravitreal injections of ranibizumab (Lucentis, Genentech), administered as frequently as every 4 weeks. In contrast, clinical trials of a soluble VEGF receptor, Aflibercept/VEGF Trap-Eye (Eylea, Regeneron Pharmaceuticals) have demonstrated maintained anatomic and visual improvement with many fewer injections (typically monthly injections for 3 months, followed by every-other-month injections, and as few as 5 injections a year). The purpose of this study is to determine whether patients who have switched from ranibizumab to VEGF Trap-Eye have comparable results.
- Being tested
- Intravitreal injection of Aflibercept
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreal injection of AfliberceptDrug
| Study group | Role | What they receive |
|---|---|---|
| Patients with Exudative Age-Related Macular Degeneration | Patients with eAMD who received intravitreal thearpy Receives: Drug: Intravitreal injection of Aflibercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exudative Age-related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Theodore Leng, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01526070
- Sponsor's protocol ID
- SU-02012012-9068
- Status last verified
- Nov 2014
- First submitted
- 1 Feb 2012
- Last updated
- 18 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bimonthly VEGF Trap-Eye Compared to As-needed Administration or Standard Therapy for Exudative Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT01526070
- Acronym / sponsor ID
- SU-02012012-9068
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 3 Feb 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.
Over the last several years, the standard of care for wet macular degeneration has become treatment with intravitreal injections of ranibizumab (Lucentis, Genentech), administered as frequently as every 4 weeks. In contrast, clinical trials of a soluble VEGF receptor, Aflibercept/VEGF Trap-Eye (Eylea, Regeneron Pharmaceuticals) have demonstrated maintained anatomic and visual improvement with many fewer injections (typically monthly injections for 3 months, followed by every-other-month injections, and as few as 5 injections a year). The purpose of this study is to determine whether patients who have switched from ranibizumab to VEGF Trap-Eye have comparable results.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Exudative Age-Related Macular Degeneration | – | Drug: Intravitreal injection of AfliberceptPatients with eAMD who received intravitreal thearpy |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with exudative age-related macular degeneration
Key inclusion criteria (4 listed)
- Patients older than the age of 50 determined by a retinal physician at the Byers Eye Institute at Stanford to have exudative AMD requiring treatment.
- Patients with an established diagnosis of exudative AMD who have been maintained on a regimen of intravitreal ranibizumab injections.
- Postmenopausal or negative pregnancy test
- Patients with an established diagnois of exidative AMD who have been switched from intravitreal ranibizumab to intravitreal VEGF Trap-EYE.
Key exclusion criteria (18 listed)
- Patients with any previous or concurrent history of treatment of other retinal diseases with pharmacologic agents other than ranibizumab, including verteporfin photodynamic therapy, bevacizumab, triamcinolone, or dexamethasone.
- Patients with prior history of vitrectomy surgery in the study eye.
- Patients enrolled in any previous or current clinical trial or study of any medication for AMD or any other retinal vascular disease, including diabetic retinopathy or retinal vein occlusion.
- Ocular media opacity precluding proper retinal imaging
- Inadequate pupillary dilation to achieve proper retinal imaging
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 |
|---|---|---|
| Intravitreal injection of Aflibercept | Drug | Patients with Exudative Age-Related Macular Degeneration |
Primary outcome
Visual Acuity
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2014.
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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?
An observational study of Exudative Age-related Macular Degeneration, run by Stanford University 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 4 inclusion and 18 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: finished, as of the sponsor's last update on 18 Nov 2014. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Visual Acuity (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Nov 2014.