Clinical Assessment Of Age-related Macular Degeneration Pati... https://clinicaltrials.gov/ct2/show/NCT01402544?term="kang+... Find Studies About Studies Submit Studies Resources About Site Trial record 1 of 5 for:    "kang zhang" Previous Study Return to List Next Study Clinical Assessment Of Age-related Macular Degeneration Patients After Early Diagnosis and Treatment With Ranibizumab (COMPASS) ClinicalTrials.gov Identifier: The safety and scientific validity of this study is the responsibility of the study sponsor and NCT01402544 Recruitment Status ! : Terminated (Per study sponsor investigators. Listing a study decision.) does not mean it has been First Posted ! : July 26, 2011 evaluated by the U.S. Federal Government. Read our disclaimer Last Update Posted ! : July 18, 2016 for details. Sponsor: Kang Zhang, MD, PhD Collaborator: Genentech, Inc. Information provided by (Responsible Party): Kang Zhang, MD, PhD, University of California, San Diego Study Details 1 of 7 Tabular View No Results Posted Disclaimer 4/12/19, 4:05 PM Clinical Assessment Of Age-related Macular Degeneration Pati... https://clinicaltrials.gov/ct2/show/NCT01402544?term="kang+... How to Read a Study Record Go to  Study Description Brief Summary: To determine if patients treated early after diagnosis of wet age-related macular degeneration can return/maintain to their baseline pre-disease BCVA. Condition or disease ! Intervention/treatment ! Phase ! Age-Related Macular Degeneration Drug: ranibizumab Phase 2 Phase 3 Detailed Description: We will conduct an open label, multi-center study of naïve AMD patients that are identified early upon disease progression (had a normal VA, FA or OCT within 4 months prior to entry) to assess if treating with ranibizumab monthly can restore all patients to their baseline vision pre-AMD. Recent randomized clinical trials (MARINA, ANCHOR) have conclusively demonstrated that continued intravitreal therapy with ranibizumab in patients with subfoveal CNV from AMD leads to stabilization of vision in over 90% of patients and improvement in vision in at least a third of the patients and has led to the approval of ranibizumab (0.5 mg) for the treatment of neovascular AMD. Patients will receive monthly intravitreal ranibizumab injections for 12 months (with dose holding for return to baseline/ 20/20 or better and no evidence of fluid on SD-OCT or FA). All patients will have ETDRS vision and SD-OCT, and complete exam at each monthly visit. Patients will each have a blood analysis for genetics (either during the GALLEY study in which they converted to wet AMD and entered COMPASS or during this study). Go to  Study Design Study Type ! : Interventional  (Clinical Trial) Actual Enrollment ! : 20 participants Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment 2 of 7 4/12/19, 4:05 PM Clinical Assessment Of Age-related Macular Degeneration Pati... https://clinicaltrials.gov/ct2/show/NCT01402544?term="kang+... Official Title: Clinical Assessment Of Age-related Macular Degeneration Patients After Early Diagnosis and Treatment With Ranibizumab (COMPASS) Study Start Date ! : July 2011 Actual Primary Completion Date ! : March 2015 Actual Study Completion Date ! : March 2015 Resource links provided by the National Library of Medicine Genetics Home Reference related topics: Agerelated macular degeneration MedlinePlus related topics: Macular Degeneration Drug Information available for: Ranibizumab U.S. FDA Resources Arms and Interventions Go to  Arm ! Intervention/treatment ! Ranibizumab 0.5 mg Drug: ranibizumab Ranibizumab 0.5 mg Intravitreal 0.5mg intravitreal injection, monthly for 12 Injection, monthly, open-label, for the months, or until BCVA returns to pre-wet duration of 1 year AMD baseline. Other Name: Lucentis Outcome Measures Go to  Primary Outcome Measures ! : 1. Pre-wet AMD baseline visual acuity [ Time Frame: Monthly for 12 months ] 3 of 7 4/12/19, 4:05 PM Clinical Assessment Of Age-related Macular Degeneration Pati... https://clinicaltrials.gov/ct2/show/NCT01402544?term="kang+... % of patients that achieve their pre-wet AMD baseline vision within 12 months Secondary Outcome Measures ! : 1. Mean change in BCVA at 6 and 12 months [ Time Frame: Month 6 and Month 12 in 12month time frame ] Mean change in BCVA at 6 and 12 months 2. Mean change in CFT at 6 and 12 months [ Time Frame: Month 6 and Month 12 in 12month study time frame ] Mean change in CFT at 6 and 12 months 3. Genome variations contributing to onset, progression and severity of CNV. [ Time Frame: End of 12-month study time frame ] Genome variations contribution/prediction to onset, progression and severity of CNV (lesion size and BCVA), the efficacy of treatment relative to gene status. Eligibility Criteria Go to  Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies. Ages Eligible for Study:   50 Years and older   (Adult, Older Adult) Sexes Eligible for Study:   All Accepts Healthy Volunteers:   No 4 of 7 4/12/19, 4:05 PM Clinical Assessment Of Age-related Macular Degeneration Pati... https://clinicaltrials.gov/ct2/show/NCT01402544?term="kang+... Criteria Inclusion Criteria: Ability to provide written informed consent and comply with study assessments for the full duration of the study Age > 50 years Naïve wet-AMD within 4 months of disease onset (for GALLEY patients) and within 3 months of disease onset for all others Patients that have lost > 5 letters from baseline best vision BCVA 20/25-20/320 Exclusion Criteria: Pregnancy (positive pregnancy test) or lactation Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch. Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated Participation in another simultaneous medical investigation or trial which includes an intervention (Patients could be participating in a non-interventional study such as the GALLEY study) Juxtafoveal and extrafoveal wet-AMD Contacts and Locations 5 of 7 Go to  4/12/19, 4:05 PM Clinical Assessment Of Age-related Macular Degeneration Pati... https://clinicaltrials.gov/ct2/show/NCT01402544?term="kang+... Information from the National Library of Medicine 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): NCT01402544 Locations United States, California California Retina Consultants Bakersfield, California, United States, 93309 Shiley Eye Center, UCSD La Jolla, California, United States, 92093 California Retina Consultants Santa Barbara, California, United States, 93103 United States, Texas Medical Center Ophthalmology Associates San Antonio, Texas, United States, 78240 Sponsors and Collaborators Kang Zhang, MD, PhD Genentech, Inc. Investigators Principal Investigator: Kang Zhang, MD, PhD University of California, San Diego More Information Go to  Additional Information: Related Info  6 of 7 4/12/19, 4:05 PM Clinical Assessment Of Age-related Macular Degeneration Pati... Responsible Party: https://clinicaltrials.gov/ct2/show/NCT01402544?term="kang+... Kang Zhang, MD, PhD, Professor of Ophthalmology and Human Genetics, University of California, San Diego ClinicalTrials.gov Identifier: NCT01402544     History of Changes Other Study ID Numbers: 110567 First Posted: July 26, 2011    Key Record Dates Last Update Posted: July 18, 2016 Last Verified: July 2016 Individual Participant Data (IPD) Sharing Statement: Plan to Share IPD: No Keywords provided by Kang Zhang, MD, PhD, University of California, San Diego: AMD Choroidal neovascularization Ranibizumab Age-related Macular Degeneration Genome Additional relevant MeSH terms: Macular Degeneration Angiogenesis Modulating Agents Retinal Degeneration Growth Substances Retinal Diseases Physiological Effects of Drugs Eye Diseases Growth Inhibitors Ranibizumab Antineoplastic Agents Angiogenesis Inhibitors 7 of 7 4/12/19, 4:05 PM