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Clinical Assessment Of Age-related Macular Degeneration Patients After Early Diagnosis and Treatment With Ranibizumab (COMPASS)

This study has been terminated.
(Per study sponsor decision.)
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Kang Zhang, MD, PhD, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01402544
First received: July 25, 2011
Last updated: July 14, 2016
Last verified: July 2016
  Purpose
To determine if patients treated early after diagnosis of wet age-related macular degeneration can return/maintain to their baseline pre-disease BCVA.

Condition Intervention Phase
Age-Related Macular Degeneration
Drug: ranibizumab
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Assessment Of Age-related Macular Degeneration Patients After Early Diagnosis and Treatment With Ranibizumab (COMPASS)

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Pre-wet AMD baseline visual acuity [ Time Frame: Monthly for 12 months ] [ Designated as safety issue: No ]
    % of patients that achieve their pre-wet AMD baseline vision within 12 months


Secondary Outcome Measures:
  • Mean change in BCVA at 6 and 12 months [ Time Frame: Month 6 and Month 12 in 12-month time frame ] [ Designated as safety issue: No ]
    Mean change in BCVA at 6 and 12 months

  • Mean change in CFT at 6 and 12 months [ Time Frame: Month 6 and Month 12 in 12-month study time frame ] [ Designated as safety issue: No ]
    Mean change in CFT at 6 and 12 months

  • Genome variations contributing to onset, progression and severity of CNV. [ Time Frame: End of 12-month study time frame ] [ Designated as safety issue: No ]
    Genome variations contribution/prediction to onset, progression and severity of CNV (lesion size and BCVA), the efficacy of treatment relative to gene status.


Enrollment: 20
Study Start Date: July 2011
Study Completion Date: March 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Ranibizumab 0.5 mg
Ranibizumab 0.5 mg Intravitreal Injection, monthly, open-label, for the duration of 1 year
Drug: ranibizumab
0.5mg intravitreal injection, monthly for 12 months, or until BCVA returns to pre-wet AMD baseline.
Other Name: Lucentis

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).

  Eligibility

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
Responsible Party: 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 
Study First Received: July 25, 2011
Last Updated: July 14, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by University of California, San Diego:
AMD
Choroidal neovascularization
Ranibizumab
Age-related Macular Degeneration
Genome

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Ranibizumab
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 23, 2016