Macular DegenerationPhase 2NCT00527423
Randomized, Single-Masked, Long-Term, Safety and Tolerability Study of VEGF Trap-Eye in AMD
A Phase 2 study testing VEGF Trap Eye in people with Macular Degeneration, run by Regeneron Pharmaceuticals at 33 sites in United States.
Trial summary
Rollover study for subjects in prior VEGF Trap-Eye Phase I and II studies. Primary objective is to assess long-term safety and tolerability of continuing intravitreal treatment in subjects with wet age-related macular degeneration. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Macular Degeneration
- What is being tested?
- VEGF Trap Eye
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 33 sitesUnited States
- Study dates
- Aug 2007to Oct 2011
- Phase
- Phase 2
- 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
- Prior participation in VEGF Trap-Eye Phase I and II studies
Who cannot join
- Any ocular or systemic adverse events that would preclude participation
- Presence of any condition that would jeopardize subject's participation
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
United States33 sites
Study site
Augusta, Georgia, 30909
Study site
Austin, Texas, 78705
Study site
Baltimore, Maryland, 21287
Study site
Beverly Hills, California, 90211
Study site
Boston, Massachusetts, 02114
Study site
Charlotte, North Carolina, 28210
Study site
Fort Myers, Florida, 33912
Study site
Fort Worth, Texas, 76102
Study site
Glenview, Illinois, 60026
Study site
Hagerstown, Maryland, 21740
Study site
Houston, Texas, 77030
Study site
Indianapolis, Indiana, 47280
Study site
Loma Linda, California, 92354
Study site
Lynbrook, New York, 11563
Study site
McAllen, Texas, 78503
Study site
Nashville, Tennessee, 37203
Study site
Oklahoma City, Oklahoma, 73104
Study site
Palm Springs, California, 92262
Study site
Pasadena, California, 91105
Study site
Peoria, Arizona, 85381
Study site
Phoenix, Arizona, 85020
Study site
Portland, Oregon, 97210
Study site
Poway, California, 92064
Study site
Rapid City, South Dakota, 57701
Study site
Salt Lake City, Utah, 84107
Study site
San Antonio, Texas, 78240
Study site
Stuart, Florida, 34994
Study site
Toms River, New Jersey, 08755
Study site
Tucson, Arizona, 85704
Study site
West Columbia, South Carolina, 29169
Study site
West Springfield, Massachusetts, 01089
Study site
Westlake Village, California, 91361
Study site
Winter Haven, Florida, 33880
About this study
Official title: A Randomized, Single-Masked , Long-Term, Safety and Tolerability Study of Intravitreal VEGF Trap-Eye in Subjects With Neovascular Age-related Macular Degeneration
Rollover study for subjects in prior VEGF Trap-Eye Phase I and II studies. Primary objective is to assess long-term safety and tolerability of continuing intravitreal treatment in subjects with wet age-related macular degeneration.
Read the detailed description
Randomized, Single-Masked Phase II study for subjects previously enrolled in Phase I and II studies for wet age-related macular degeneration with VEGF Trap-Eye intravitreal injection as treatment.Long term (3 years) treatment is intended to measure safety and tolerability, as well as frequency of re-treatment and the effect of VEGF Trap-Eye on best corrected visual acuity (BCVA).
- Conditions
- Macular Degeneration
- Being tested
- VEGF Trap Eye
- Keywords
- VEGF Trap-Eye, Macular Degeneration, AMD, Neovascular Age-Related Macular Degeneration
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VEGF Trap EyeDrug
Also called IVT
Intravitreal injection
| Study group | Role | What they receive |
|---|---|---|
| Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) | Experimental | Not described Receives: Drug: VEGF Trap Eye |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AE)
Number of participants with AEs summarized by category
Measured: Baseline of this study to Wk 152
Secondary outcomes (2)
Frequency (Number of Injections)
Frequency (number of injections) of PRN treatment from baseline of this study to week 152 (end of treatment).
Measured: Baseline of this study to Wk 152
Mean Change From Baseline of Original Study in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score of Study Eye - Observed Values
Defined study baseline range of ETDRS Best Corrected Visual Acuity of: letter score of 73 to 25 (20/40 to 20/320) in the study eye; a higher score represents better functioning.
Measured: Baseline of original study to Wk 156
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2007 (estimated)
- Study startAug 2007
- Primary completionOct 2011
- Study completionOct 2011
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 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 157 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
- NCT00527423
- Sponsor's protocol ID
- VGFT-OD-0702
- Status last verified
- Jun 2013
- First submitted
- 6 Sep 2007
- Last updated
- 12 Jun 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-Masked , Long-Term, Safety and Tolerability Study of Intravitreal VEGF Trap-Eye in Subjects With Neovascular Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT00527423
- Acronym / sponsor ID
- VGFT-OD-0702
- Conditions
- Macular Degeneration
- Keywords
- VEGF Trap-Eye, Macular Degeneration, AMD, Neovascular Age-Related Macular Degeneration
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Bayer
- Study start
- Aug 2007
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 10 Sep 2007 (estimated)
- Results
- Posted 12 Jun 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rollover study for subjects in prior VEGF Trap-Eye Phase I and II studies. Primary objective is to assess long-term safety and tolerability of continuing intravitreal treatment in subjects with wet age-related macular degeneration.
Detailed description
Randomized, Single-Masked Phase II study for subjects previously enrolled in Phase I and II studies for wet age-related macular degeneration with VEGF Trap-Eye intravitreal injection as treatment.Long term (3 years) treatment is intended to measure safety and tolerability, as well as frequency of re-treatment and the effect of VEGF Trap-Eye on best corrected visual acuity (BCVA).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) | Experimental | Drug: VEGF Trap Eye |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Prior participation in VEGF Trap-Eye Phase I and II studies
Key exclusion criteria (2 listed)
- Any ocular or systemic adverse events that would preclude participation
- Presence of any condition that would jeopardize subject's participation
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 |
|---|---|---|
| VEGF Trap EyeAlso: IVTIntravitreal injection | Drug | Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) |
Primary outcome
Number of Participants With Adverse Events (AE)
Time frame: Baseline of this study to Wk 152
Number of participants with AEs summarized by category
2 secondary outcomes
Frequency (Number of Injections)
Time frame: Baseline of this study to Wk 152
Mean Change From Baseline of Original Study in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score of Study Eye - Observed Values
Time frame: Baseline of original study to Wk 156
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2013.
- 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
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VEGF Trap Eye in people with Macular Degeneration, run by Regeneron Pharmaceuticals at 33 sites 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 1 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 12 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 12 Jun 2013). 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?
Number of Participants With Adverse Events (AE) (time frame: Baseline of this study to Wk 152). 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 12 Jun 2013.