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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by University of California, San Diego.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Genentech
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01402544
First received: July 25, 2011
Last updated: NA
Last verified: July 2011
History: No changes posted
  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

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.


Estimated Enrollment: 40
Study Start Date: July 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01402544

Contacts
Contact: Clara J Lee, BS 858-246-0440 CJL015@ucsd.edu
Contact: Della M Morales, BS 858-246-0270 dmm003@ucsd.edu

Locations
United States, California
California Retina Consultants Recruiting
Bakersfield, California, United States, 93309
Contact: Melvin Rabena    858-963-1648 ext 27    mdrabena@yahoo.com   
Sub-Investigator: Dante Pieramici, MD         
Shiley Eye Center, UCSD Recruiting
La Jolla, California, United States, 92093
Contact: Clara J Lee, BS    858-246-0440    cjl015@ucsd.edu   
Contact: Della M Morales, BS    858-246-0270    dmm003@ucsd.edu   
Principal Investigator: Kang Zhang, MD, PhD         
California Retina Consultants Recruiting
Santa Barbara, California, United States, 93103
Contact: Melvin Rabena    805-963-1648 ext 27    mdrabena@yahoo.com   
Sub-Investigator: Robert Avery, MD         
United States, Texas
Medical Center Ophthalmology Associates Recruiting
San Antonio, Texas, United States, 78240
Contact: Roxanne Gomez    210-697-2036 ext 2232    roxanne@mcoaeyecare.com   
Sub-Investigator: Mike Singer, MD         
Sponsors and Collaborators
University of California, San Diego
Genentech
Investigators
Principal Investigator: Kang Zhang, MD, PhD University of California, San Diego
  More Information

No publications provided

Responsible Party: Kang Zhang, MD, PhD, UCSD, Shiley Eye Center
ClinicalTrials.gov Identifier: NCT01402544     History of Changes
Other Study ID Numbers: 100471
Study First Received: July 25, 2011
Last Updated: July 25, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 17, 2014