Age-related Macular DegenerationSEVEN UPNCT01256827
Seven Year Update of Macular Degeneration Patients
An observational study of Age-related Macular Degeneration, run by University of California, San Francisco at 12 sites in United States.
Trial summary
The purpose is to assess long term vision outcomes and disease status in patients with age-related macular degeneration previously treated with ranibizumab as participants in the Phase 3 ANCHOR and MARINA Studies and the HORIZON Study. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Age-related Macular Degeneration
- How many people
- 65 participants
- Where
- 12 sitesUnited States
- Study dates
- Dec 2010to Apr 2013
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Exudative AMD patients who were previously participants in ranibizumab treatment arms of the ANCHOR or MARINA studies, and who subsequently enrolled in the HORIZON extension study
Who may be able to join
- previous participants in the ANCHOR or MARINA studies, and...
- who were assigned to one of the ranibizumab treatment arms, and...
- who were enrolled in the HORIZON extension study with a current SEVEN UP investigator
- ability to provide written informed consent and comply with study assessments
Who cannot join
- any separate ophthalmologic condition that the investigator believes would interfere with anatomic assessments in the trial
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Retina Research Center
Austin, Texas, 78705
Retina-Vitreous Associates
Beverly Hills, California, 90211
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114
Charlotte Eye, Ear, Nose & Throat Associates
Charlotte, North Carolina, 28210
Retina Consultants of Houston
Houston, Texas, 77030
Midwest Eye institute
Indianapolis, Indiana, 46290
USC Keck School of Medicine, Doheny Eye Institute
Los Angeles, California, 90033
Northern California Retina Vitreous Associates
Mountain View, California, 94040
Tennessee Retina
Nashville, Tennessee, 37203
Black Hills Regional Eye Institute
Rapid City, South Dakota, 57701
Medical Center Ophthalmology Associates
San Antonio, Texas, 78240
University of California San Francisco
San Francisco, California, 94143
About this study
Official title: Seven Year Observational Update of Macular Degeneration Patients Post-MARINA/ANCHOR and HORIZON Trials (SEVEN UP Study)
The purpose is to assess long term vision outcomes and disease status in patients with age-related macular degeneration previously treated with ranibizumab as participants in the Phase 3 ANCHOR and MARINA Studies and the HORIZON Study.
Read the detailed description
This is a cross-sectional cohort study of exudative age-related macular degeneration (AMD) patients seven or more years after initiation of the intravitreal ranibizumab regimen in the treatment arms of the pivotal ANCHOR or MARINA studies, who had subsequent follow up in the HORIZON Study. While the MARINA and ANCHOR studies established the benefit of ranibizumab at 2 years, many patients in the U.S. have now undergone treatment for many years, and the longer-term outcomes for this chronic disease remain unknown. Despite earlier hopes for limited duration treatment, subsequent clinical experience suggests that many patients require continued treatment. The patient population for this study is unique, in that the patients in the treatment arms of MARINA and ANCHOR are some of the earliest treated patients, providing the longest-term data available for AMD patients receiving ranibizumab. Patients recalled into this study will be evaluated to provide an update on their current visual acuity, disease activity status, anatomic characteristics, and genotype. There is a single study visit to extend the clinical history and to perform vision testing, ophthalmologic examination, and retinal imaging studies, including high-resolution spectral-domain OCT and fundus autofluorescence imaging, technologies unavailable at the time of the original ANCHOR and MARINA Trials. Genetic analysis will be performed for known AMD risk genes as well as candidate genes to study genotypic profiles associated with AMD disease progression and long-term treatment response. Understanding the course of 7-plus years of current generation AMD treatment will serve physicians in the ongoing management of this chronic disease.
- Conditions
- Age-related Macular Degeneration
- Keywords
- age-related macular degeneration, ranibizumab, geographic atrophy, ANCHOR Study, MARINA Study
- Medical subject headings
- Macular Degeneration, Geographic Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ranibizumab in MARINA/ANCHOR | Exudative AMD patients previously enrolled in the ranibizumab treatment arms of the MARINA or ANCHOR studies with subsequent enrollment into the HORIZON extension study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual acuity 20/70 or better
percentage of study eyes with vision of 20/70 or better (ETDRS best-corrected vision with Snellen equivalent)
Measured: at date of study visit
Secondary outcomes (6)
mean change in visual acuity
Mean change in ETDRS best-corrected vision in study eyes, relative to baseline, exit from MARINA or ANCHOR, and exit from HORIZON
Measured: at study visit
visual acuity 20/200 or worse
% of study eyes with ETDRS best-corrected visual acuity 20/200 or worse
Measured: at date of study visit
visual acuity 20/40 or better
% of study eyes with ETDRS best-corrected visual acuity 20/40 or better
Measured: at date of study visit
exudative AMD disease quiescence
% of eyes that have attained disease quiescence, defined by: 1) No leakage (SRF, PED, CME, CFT greater than 250 um on OCT) on clinical exam or on studies. 2) no subretinal intraretinal hemorrhage on clinical exam or FA, 3) Historical: none of the above in the last 6 months by chart review or history, and no treatment for exudative AMD within the last 6 months.
Measured: at date of study visit and 6 months prior history
central geographic atrophy
% of patients: 1) with central geographic atrophy (GA); 2) demonstrating progression of GA compared to baseline, exit from MARINA/ANCHOR, and exit from HORIZON; 3) with fellow eye GA development. GA measured by: fundus autofluorescence, high resolution OCT, and by interval comparison of fundus photography and fluorescein angiography
Measured: date of study visit
genotypic profile
Genome-wide screening for high interest genes for associations with: geographic atrophy, disciform scar, current disease activity, therapeutic response to ranibizumab therapy
Measured: date of study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionOct 2012
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Cross-sectional
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Robert B. Bhisitkul, MD, PhD, Principal investigator, University of California, San FranciscoDavid S. Boyer, MD, Study director, Retina-Vitreous AssociatesSriniVas Sadda, MD, Study director, USC Keck School of Medicine, Doheny Eye InstituteKang Zhang, MD, PhD, Study director, University of California San Diego, Shiley Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01256827
- Sponsor's protocol ID
- IST-72116
- Other IDs
- FVF 4938s
- Acronym
- SEVEN UP
- Status last verified
- Nov 2013
- First submitted
- 7 Dec 2010
- Last updated
- 14 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seven Year Observational Update of Macular Degeneration Patients Post-MARINA/ANCHOR and HORIZON Trials (SEVEN UP Study)
- ClinicalTrials.gov ID
- NCT01256827
- Acronym / sponsor ID
- SEVEN UP / IST-72116
- Conditions
- Age-related Macular Degeneration
- Keywords
- age-related macular degeneration, ranibizumab, geographic atrophy, ANCHOR Study, MARINA Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Dec 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 9 Dec 2010 (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 is to assess long term vision outcomes and disease status in patients with age-related macular degeneration previously treated with ranibizumab as participants in the Phase 3 ANCHOR and MARINA Studies and the HORIZON Study.
Detailed description
This is a cross-sectional cohort study of exudative age-related macular degeneration (AMD) patients seven or more years after initiation of the intravitreal ranibizumab regimen in the treatment arms of the pivotal ANCHOR or MARINA studies, who had subsequent follow up in the HORIZON Study. While the MARINA and ANCHOR studies established the benefit of ranibizumab at 2 years, many patients in the U.S. have now undergone treatment for many years, and the longer-term outcomes for this chronic disease remain unknown. Despite earlier hopes for limited duration treatment, subsequent clinical experience suggests that many patients require continued treatment. The patient population for this study is unique, in that the patients in the treatment arms of MARINA and ANCHOR are some of the earliest treated patients, providing the longest-term data available for AMD patients receiving ranibizumab. Patients recalled into this study will be evaluated to provide an update on their current visual acuity, disease activity status, anatomic characteristics, and genotype. There is a single study visit to extend the clinical history and to perform vision testing, ophthalmologic examination, and retinal imaging studies, including high-resolution spectral-domain OCT and fundus autofluorescence imaging, technologies unavailable at the time of the original ANCHOR and MARINA Trials. Genetic analysis will be performed for known AMD risk genes as well as candidate genes to study genotypic profiles associated with AMD disease progression and long-term treatment response. Understanding the course of 7-plus years of current generation AMD treatment will serve physicians in the ongoing management of this chronic disease.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ranibizumab in MARINA/ANCHOR | – | –Exudative AMD patients previously enrolled in the ranibizumab treatment arms of the MARINA or ANCHOR studies with subsequent enrollment into the HORIZON extension study. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Exudative AMD patients who were previously participants in ranibizumab treatment arms of the ANCHOR or MARINA studies, and who subsequently enrolled in the HORIZON extension study
Key inclusion criteria (4 listed)
- previous participants in the ANCHOR or MARINA studies, and...
- who were assigned to one of the ranibizumab treatment arms, and...
- who were enrolled in the HORIZON extension study with a current SEVEN UP investigator
- ability to provide written informed consent and comply with study assessments
Key exclusion criteria (1 listed)
- any separate ophthalmologic condition that the investigator believes would interfere with anatomic assessments in the trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
visual acuity 20/70 or better
Time frame: at date of study visit
percentage of study eyes with vision of 20/70 or better (ETDRS best-corrected vision with Snellen equivalent)
6 secondary outcomes
mean change in visual acuity
Time frame: at study visit
visual acuity 20/200 or worse
Time frame: at date of study visit
visual acuity 20/40 or better
Time frame: at date of study visit
exudative AMD disease quiescence
Time frame: at date of study visit and 6 months prior history
central geographic atrophy
Time frame: date of study visit
genotypic profile
Time frame: date of study visit
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 14 Nov 2013.
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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.
Robert B. Bhisitkul, MD, PhD principal investigator
University of California, San Francisco
David S. Boyer, MD study director
Retina-Vitreous Associates
SriniVas Sadda, MD study director
USC Keck School of Medicine, Doheny Eye Institute
12 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 Macular Degeneration, run by University of California, San Francisco at 12 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 4 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: finished, as of the sponsor's last update on 14 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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 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 20/70 or better (time frame: at date of study visit). 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 14 Nov 2013.