Seven Year Update of Macular Degeneration Patients (SEVEN UP)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01256827 |
Recruitment Status :
Completed
First Posted : December 9, 2010
Last Update Posted : November 14, 2013
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Condition or disease |
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Age-related Macular Degeneration |
Study Type : | Observational |
Actual Enrollment : | 65 participants |
Observational Model: | Cohort |
Time Perspective: | Cross-Sectional |
Official Title: | Seven Year Observational Update of Macular Degeneration Patients Post-MARINA/ANCHOR and HORIZON Trials (SEVEN UP Study) |
Study Start Date : | December 2010 |
Actual Primary Completion Date : | October 2012 |
Actual Study Completion Date : | April 2013 |

Group/Cohort |
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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.
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- 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)
- mean change in visual acuity [ Time Frame: at study visit ]Mean change in ETDRS best-corrected vision in study eyes, relative to baseline, exit from MARINA or ANCHOR, and exit from HORIZON
- visual acuity 20/200 or worse [ Time Frame: at date of study visit ]% of study eyes with ETDRS best-corrected visual acuity 20/200 or worse
- visual acuity 20/40 or better [ Time Frame: at date of study visit ]% of study eyes with ETDRS best-corrected visual acuity 20/40 or better
- exudative AMD disease quiescence [ Time Frame: at date of study visit and 6 months prior history ]% 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.
- central geographic atrophy [ Time Frame: date of study visit ]% 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
- genotypic profile [ Time Frame: date of study visit ]Genome-wide screening for high interest genes for associations with: geographic atrophy, disciform scar, current disease activity, therapeutic response to ranibizumab therapy
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 55 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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
Exclusion Criteria:
- any separate ophthalmologic condition that the investigator believes would interfere with anatomic assessments in the trial

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01256827
United States, California | |
Retina-Vitreous Associates | |
Beverly Hills, California, United States, 90211 | |
USC Keck School of Medicine, Doheny Eye Institute | |
Los Angeles, California, United States, 90033 | |
Northern California Retina Vitreous Associates | |
Mountain View, California, United States, 94040 | |
University of California San Francisco | |
San Francisco, California, United States, 94143 | |
United States, Indiana | |
Midwest Eye institute | |
Indianapolis, Indiana, United States, 46290 | |
United States, Massachusetts | |
Ophthalmic Consultants of Boston | |
Boston, Massachusetts, United States, 02114 | |
United States, North Carolina | |
Charlotte Eye, Ear, Nose & Throat Associates | |
Charlotte, North Carolina, United States, 28210 | |
United States, South Dakota | |
Black Hills Regional Eye Institute | |
Rapid City, South Dakota, United States, 57701 | |
United States, Tennessee | |
Tennessee Retina | |
Nashville, Tennessee, United States, 37203 | |
United States, Texas | |
Retina Research Center | |
Austin, Texas, United States, 78705 | |
Retina Consultants of Houston | |
Houston, Texas, United States, 77030 | |
Medical Center Ophthalmology Associates | |
San Antonio, Texas, United States, 78240 |
Principal Investigator: | Robert B. Bhisitkul, MD, PhD | University of California, San Francisco | |
Study Director: | David S. Boyer, MD | Retina-Vitreous Associates | |
Study Director: | SriniVas Sadda, MD | USC Keck School of Medicine, Doheny Eye Institute | |
Study Director: | Kang Zhang, MD, PhD | University of California San Diego, Shiley Eye Center |
Responsible Party: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT01256827 |
Other Study ID Numbers: |
IST-72116 FVF 4938s ( Other Identifier: Genentech, Inc. ) |
First Posted: | December 9, 2010 Key Record Dates |
Last Update Posted: | November 14, 2013 |
Last Verified: | November 2013 |
age-related macular degeneration ranibizumab geographic atrophy ANCHOR Study MARINA Study |
Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases |