Age-Related MaculopathySEAGULNCT00474695
Study Evaluating Genotypes Using Lucentis
An observational study of Age-Related Maculopathy, run by University of Utah at 3 sites in United States.
Trial summary
The purpose of the study is to investigate whether the efficacy of Lucentis treatment for exudative age-related macular degeneration is associated with VEGF and HTRA1 DNA polymorphisms Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age-Related Maculopathy
- What is being tested?
- Lucentis
- Type of treatment
- Injection or infusion
- How many people
- 65 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2007to Dec 2009
- 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: Moran Eye Center Clinic
Who may be able to join
- Treatment naive AMD patients;
- At least 50 years of age;
- Visual acuity between 20/40 and 20/320
Who cannot join
- Pregnancy;
- Prior enrollment in a ranibizumab clinical trial;
- Previous therapy in either eye for AMD;
- Concurrent eye disease that could compromise visual acuity
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Porter Adventist Hospital
Denver, Colorado, 80210
University of Utah, Moran Eye Center
Salt Lake City, Utah, 84132
California Retina Consultants
Santa Barbara, California, 93103
About this study
Official title: VEGF and HTRA1 DNA Polymorphisms in Neovascular AMD Pathogenesis and Response to Lucentis
The purpose of the study is to investigate whether the efficacy of Lucentis treatment for exudative age-related macular degeneration is associated with VEGF and HTRA1 DNA polymorphisms
Read the detailed description
Treatment naive exudative AMD patients will receive Lucentis treatment as standard of care, and followed monthly for 12 months. Standard ophthalmologic exams will be performed, along with ETDRS visual acuity and optical coherence tomography (OCT). A blood sample will be obtained for DNA analysis. The primary outcome measure is change in visual acuity at 4 months after initial Lucentis treatment. Secondary outcomes are change in visual acuity and retinal thickness at 12 months.
- Conditions
- Age-Related Maculopathy
- Being tested
- Lucentis
- Keywords
- Exudative 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.
LucentisDrug
Also called ranibizumab
0.05 mg intravitreal injection
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active approved treatment Receives: Drug: Lucentis |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the VEGF and HTRA1 genotypes associated with improvement in visual acuity
Measured: 4 months
Secondary outcomes (1)
Determine VEGF and HTRA1 genotypes associated with change or no change in visual acuity
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2007 (estimated)
- Study startMay 2007
- Primary completionJun 2009
- Study completionDec 2009
Why it stopped: IND holder relocated from the University of Utah
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Age-Related MaculopathyStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Principal investigator, Paul S. Bernstein, University of Utah
- Investigators
- Paul Bernstein, MD, PhD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00474695
- Sponsor's protocol ID
- 21441
- Other IDs
- SEAGUL
- Acronym
- SEAGUL
- Status last verified
- Feb 2015
- First submitted
- 15 May 2007
- Last updated
- 11 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Zhao L, Grob S, Avery R, Kimura A, Pieramici D, Lee J, Rabena M, Ortiz S, Quach J, Cao G, Luo H, Zhang M, Pei M, Song Y, Tornambe P, Goldbaum M, Ferreyra H, Kozak I, Zhang K. Common variant in VEGFA and response to anti-VEGF therapy for neovascular age-related macular degeneration. Curr Mol Med. 2013 Jul;13(6):929-34. doi: 10.2174/15665240113139990048.
PubMed 23745581
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VEGF and HTRA1 DNA Polymorphisms in Neovascular AMD Pathogenesis and Response to Lucentis
- ClinicalTrials.gov ID
- NCT00474695
- Acronym / sponsor ID
- SEAGUL / 21441
- Conditions
- Age-Related Maculopathy
- Keywords
- Exudative age-related macular degeneration
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: IND holder relocated from the University of Utah
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- May 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 17 May 2007 (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.
The purpose of the study is to investigate whether the efficacy of Lucentis treatment for exudative age-related macular degeneration is associated with VEGF and HTRA1 DNA polymorphisms
Detailed description
Treatment naive exudative AMD patients will receive Lucentis treatment as standard of care, and followed monthly for 12 months. Standard ophthalmologic exams will be performed, along with ETDRS visual acuity and optical coherence tomography (OCT). A blood sample will be obtained for DNA analysis. The primary outcome measure is change in visual acuity at 4 months after initial Lucentis treatment. Secondary outcomes are change in visual acuity and retinal thickness at 12 months.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: LucentisActive approved treatment |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Moran Eye Center Clinic
Key inclusion criteria (3 listed)
- Treatment naive AMD patients;
- At least 50 years of age;
- Visual acuity between 20/40 and 20/320
Key exclusion criteria (4 listed)
- Pregnancy;
- Prior enrollment in a ranibizumab clinical trial;
- Previous therapy in either eye for AMD;
- Concurrent eye disease that could compromise visual acuity
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 |
|---|---|---|
| LucentisAlso: ranibizumab0.05 mg intravitreal injection | Drug | 1 |
Primary outcome
To determine the VEGF and HTRA1 genotypes associated with improvement in visual acuity
Time frame: 4 months
1 secondary outcome
Determine VEGF and HTRA1 genotypes associated with change or no change in visual acuity
Time frame: 12 months
Results and safety
The study was stopped early (reason given: IND holder relocated from the University of Utah). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2015.
- Derived from this study: PubMed 23745581Zhao L, Grob S, Avery R, Kimura A, Pieramici D, Lee J, Rabena M, Ortiz S, Quach J, Cao G, Luo H, Zhang M, Pei M, Song Y, Tornambe P, Goldbaum M, Ferreyra H, Kozak I, Zhang K. Common variant in VEGFA and response to anti-VEGF therapy for neovascular age-related macular degeneration. Curr Mol Med. 2013 Jul;13(6):929-34. doi: 10.2174/15665240113139990048.
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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.
Paul Bernstein, MD, PhD principal investigator
University of Utah
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Age-Related Maculopathy, run by University of Utah at 3 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 3 inclusion and 4 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: stopped early, as of the sponsor's last update on 11 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
Are results available for this study?
The study was stopped early (reason given: IND holder relocated from the University of Utah). 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.
What does the primary outcome measure?
To determine the VEGF and HTRA1 genotypes associated with improvement in visual acuity (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00474695, which also lists 1 linked publication.
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 11 Feb 2015.