Neovascular Age-related Macular DegenerationPhase 3NCT00964795
Open-label Extension Study of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in Neovascular ("Wet") Age-related Macular Degeneration (AMD)
A Phase 3 study testing Intravitreal Aflibercept Injection 2mg in people with Neovascular Age-related Macular Degeneration, run by Regeneron Pharmaceuticals at 124 sites in 2 countries.
Trial summary
The primary objective is to assess long-term safety and tolerability of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in patients with neovascular AMD. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Neovascular Age-related Macular Degeneration
- What is being tested?
- Intravitreal Aflibercept Injection 2mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 323 participants
- Where
- 124 sitesin 2 countries
- Study dates
- Dec 2009to Aug 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Participation in Study VGFT-OD-0605 through week 96.
- In the opinion of the investigator, the study eye has neovascular AMD and may continue to require treatment.
Who cannot join
- Presence of any condition that would jeopardize the patient's participation in this study.
- Females who are pregnant, breastfeeding, or of childbearing potential, unwilling to practice adequate contraception throughout the study.
Trial locations and contacts
124 sites in 2 countries.
124 sites in 2 countries
United States115 sites
Study site
‘Aiea, Hawaii
Study site
Albany, New York
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Albuquerque, New Mexico
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Altamonte Springs, Florida
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Ann Arbor, Michigan
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Arcadia, California
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Asheville, North Carolina
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Ashland, Oregon
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Augusta, Georgia
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Austin (3 Locations), Texas
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Baltimore (3 Locations), Maryland
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Bangor, Maine
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Battle Creek, Michigan
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Beverly Hills, California
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Birmingham (2 Locations), Alabama
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Boston (2 Locations), Massachusetts
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Boynton Beach, Florida
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Bridgeport, Connecticut
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Brooklyn, New York
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Burlington, Vermont
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Campbell, California
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Charlotte, North Carolina
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Charlottesville, Virginia
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Chevy Chase, Maryland
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Cincinnati, Ohio
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Cleveland, Ohio
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Colorado Springs, Colorado
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Columbia, South Carolina
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Dallas, Texas
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Denver (2 Locations), Colorado
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Fairfax, Virginia
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Florissant, Missouri
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Fort Myers (2 Locations), Florida
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Fort Wayne, Indiana
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Fort Worth (2 Locations), Texas
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Fresno, California
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Fullerton, California
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Glenview, Illinois
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Grand Rapids, Michigan
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Greenville, South Carolina
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Hagerstown, Maryland
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Houston, Texas
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Indianapolis, Indiana
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Iowa City, Iowa
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Jackson, Michigan
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Jacksonville, Florida
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Kansas City, Missouri
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Kingston, Pennsylvania
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La Jolla, California
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Las Vegas, Nevada
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Lawrenceville, New Jersey
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Lincoln, Nebraska
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Loma Linda, California
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Louisville, Kentucky
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Lynbrook, New York
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Madison (2 Locations), Wisconsin
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McAllen, Texas
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Miami, Florida
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Milwaukee, Wisconsin
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Minneapolis, Minnesota
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Missoula, Montana
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Mountain View, California
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Nashville, Tennessee
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New Albany, Indiana
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New Haven, Connecticut
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New London, Connecticut
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New Orleans, Louisiana
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New York (6 Locations), New York
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Northfield, New Jersey
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Oakland, California
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Odessa, Texas
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Oklahoma City, Oklahoma
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Orange, California
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Orlando (2 Locations), Florida
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Oscala, Florida
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Palm Beach Gardens, Florida
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Palm Desert, California
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Peabody, Massachusetts
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Pensacola, Florida
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Philadelphia (3 Locations), Pennsylvania
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Phoenix (2 Locations), Arizona
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Pittsburgh (2 Locations), Pennsylvania
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Portland, Maine
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Portland (3 Locations), Oregon
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Portsmouth, New Hampshire
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Raleigh, North Carolina
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Rapid City, South Dakota
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Richmond, Virginia
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Rochester, Minnesota
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Rochester (2 Locations), New York
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Sacramento, California
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Salem, Oregon
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Salt Lake City (2 Locations), Utah
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San Antonio (2 Locations), Texas
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San Mateo, California
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Santa Ana, California
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Seattle, Washington
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Slingerlands, New York
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Southfield, Michigan
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Springfield, Missouri
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St Louis, Missouri
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Stuart, Florida
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Syracuse, New York
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Tampa, Florida
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Toms River, New Jersey
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Torrance, California
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Tucson (2 Locations), Arizona
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Tyler, Texas
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West Columbia, South Carolina
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West Mifflin, Pennsylvania
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Westlake Village, California
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Wichita, Kansas
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Winston-Salem, North Carolina
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Winter Haven, Florida
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Yorba Linda, California
Canada9 sites
Study site
Calgary, Alberta
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Halifax, Nova Scotia
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London, Ontario
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Mississauga, Ontario
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Montreal (2 Locations), Quebec
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Ottawa, Ontario
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Regina, Saskatchewan
Study site
Vancouver, British Columbia
Study site
Victoria, British Columbia
About this study
Official title: An Open-label, Long-term, Safety and Tolerability Extension Study of Intravitreal VEGF Trap-Eye in Neovascular Age-Related Macular Degeneration
The primary objective is to assess long-term safety and tolerability of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in patients with neovascular AMD.
Read the detailed description
The dose evaluated in this study, Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2mg, will be the higher of the 2 dose strengths evaluated in parent study VGFT-OD-0605 (NCT00509795) and is the dose level administered in study VGFT-OD-0702 (NCT00527423), a long-term open-label extension study. For these reasons, this dose has been selected for this extension study.
Participants will be seen in the clinic for quarterly visits starting with day 1 to assess safety. Study drug will be administered on an as-needed basis at the discretion of the investigator with a minimum allowed interval of every 4 weeks and a maximum allowed interval of every 12 weeks. This study will assess the frequency that re-treatment is needed and the effect of continued Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) treatment on BCVA.
- Being tested
- Intravitreal Aflibercept Injection 2mg
- Keywords
- Eyes, Neovascular, Macular Degeneration, Retina, AMD, VEGF Trap-Eye, Best Corrected Visual Acuity
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreal Aflibercept Injection 2mgDrug
Also called IAI; EYLEA®; BAY86-5321; VEGF Trap-Eye
| Study group | Role | What they receive |
|---|---|---|
| Open-label Intravitreal Aflibercept Injection | Experimental | Open-label Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2mg (40 mg/mL) was administered no more frequently than every 4 weeks, but no less frequently than every 12 weeks until amendment 4. Starting with amendment 4, Intravitreal Aflibercept Injection was administered no less frequently than every 8 weeks. Within these limits, the investigator would determine the interval of Intravitreal Aflibercept Injection administration on an as-needed basis according to the protocol-suggested re-treatment criteria, however the injections must have occurred at least every 12 weeks prior to amendment 4, and at least every 8 weeks starting from amendment 4 as noted above. Receives: Drug: Intravitreal Aflibercept Injection 2mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of Intravitreal Aflibercept Injection in Participants With Neovascular AMD
The primary endpoint in the study is the safety and tolerability of Intravitreal Aflibercept Injection in patients with neovascular AMD (Age-related Macular Degeneration) from day 1 through the end of treatment visit (week 180) based on the number of participants who experienced any treatment-emergent adverse event (TEAE).
Treatment-emergent adverse events were categorized according to Ocular TEAEs in the study eye, Ocular TEAEs in the fellow eye, and Non-Ocular TEAEs
Measured: Baseline (day 1) through end of treatment (Week 180)
Secondary outcomes (1)
Change in BCVA Letter Score (mLOCF)
The secondary endpoint in the study is the change in BCVA letter score from baseline through Week 116.
(mLOCF: The last non-missing observation prior to the missing visit was carried forward to impute the missing data; no imputation after last visit; no baseline value carried forward).
Measured: Baseline through Week 116
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2009 (estimated)
- Study startDec 2009
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Neovascular Age-related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 323 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00964795
- Sponsor's protocol ID
- VGFT-OD-0910
- Status last verified
- Mar 2015
- First submitted
- 20 Aug 2009
- Last updated
- 23 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Long-term, Safety and Tolerability Extension Study of Intravitreal VEGF Trap-Eye in Neovascular Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT00964795
- Acronym / sponsor ID
- VGFT-OD-0910
- Keywords
- Eyes, Neovascular, Macular Degeneration, Retina, AMD, VEGF Trap-Eye, Best Corrected Visual Acuity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 323 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Bayer
- Study start
- Dec 2009
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 25 Aug 2009 (estimated)
- Results
- Posted 23 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to assess long-term safety and tolerability of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in patients with neovascular AMD.
Detailed description
The dose evaluated in this study, Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2mg, will be the higher of the 2 dose strengths evaluated in parent study VGFT-OD-0605 (NCT00509795) and is the dose level administered in study VGFT-OD-0702 (NCT00527423), a long-term open-label extension study. For these reasons, this dose has been selected for this extension study.
Participants will be seen in the clinic for quarterly visits starting with day 1 to assess safety. Study drug will be administered on an as-needed basis at the discretion of the investigator with a minimum allowed interval of every 4 weeks and a maximum allowed interval of every 12 weeks. This study will assess the frequency that re-treatment is needed and the effect of continued Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) treatment on BCVA.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open-label Intravitreal Aflibercept Injection | Experimental | Drug: Intravitreal Aflibercept Injection 2mgOpen-label Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2mg (40 mg/mL) was administered no more frequently than every 4 weeks, but no less frequently than every 12 weeks until amendment 4. Starting with amendment 4, Intravitreal Aflibercept Injection was administered no less frequently than every 8 weeks. Within these limits, the investigator would determine the interval of Intravitreal Aflibercept Injection administration on an as-needed basis according to the protocol-suggested re-treatment criteria, however the injections must have occurred at least every 12 weeks prior to amendment 4, and at least every 8 weeks starting from amendment 4 as noted above. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participation in Study VGFT-OD-0605 through week 96.
- In the opinion of the investigator, the study eye has neovascular AMD and may continue to require treatment.
Key exclusion criteria (2 listed)
- Presence of any condition that would jeopardize the patient's participation in this study.
- Females who are pregnant, breastfeeding, or of childbearing potential, unwilling to practice adequate contraception throughout the study.
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 Aflibercept Injection 2mgAlso: IAI; EYLEA®; BAY86-5321; VEGF Trap-Eye | Drug | Open-label Intravitreal Aflibercept Injection |
Primary outcome
Safety and Tolerability of Intravitreal Aflibercept Injection in Participants With Neovascular AMD
Time frame: Baseline (day 1) through end of treatment (Week 180)
The primary endpoint in the study is the safety and tolerability of Intravitreal Aflibercept Injection in patients with neovascular AMD (Age-related Macular Degeneration) from day 1 through the end of treatment visit (week 180) based on the number of participants who experienced any treatment-emergent adverse event (TEAE). Treatment-emergent adverse events were categorized according to Ocular TEAEs in the study eye, Ocular TEAEs in the fellow eye, and Non-Ocular TEAEs
1 secondary outcome
Change in BCVA Letter Score (mLOCF)
Time frame: Baseline through Week 116
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Clinical Trial Management study director
Regeneron Pharmaceuticals
124 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intravitreal Aflibercept Injection 2mg in people with Neovascular Age-related Macular Degeneration, run by Regeneron Pharmaceuticals at 124 sites in 2 countries.
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 2 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 23 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 124 sites in United States, Canada. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Safety and Tolerability of Intravitreal Aflibercept Injection in Participants With Neovascular AMD (time frame: Baseline (day 1) through end of treatment (Week 180)). 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 23 Mar 2015.