search
Back to results

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

Primary Purpose

Age-Related Macular Degeneration

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ranibizumab
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age-Related Macular Degeneration focused on measuring AMD, Choroidal neovascularization, Ranibizumab, Age-related Macular Degeneration, Genome

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • California Retina Consultants
  • Shiley Eye Center, UCSD
  • California Retina Consultants
  • Medical Center Ophthalmology Associates

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Ranibizumab 0.5 mg

Arm Description

Ranibizumab 0.5 mg Intravitreal Injection, monthly, open-label, for the duration of 1 year

Outcomes

Primary Outcome Measures

Number of Patients That Achieve Their Pre-wet Age-Related Macular Degeneration (AMD) Baseline Visual Acuity Within 12 Months
PI is no longer affiliated with institution. All efforts were exhausted to obtain data from all sites for this study, but we only have access to data from UCSD site. Data from these participants is being reported here.

Secondary Outcome Measures

Mean Change in Best Corrected Visual Acuity (BCVA) From Baseline to 6 Months and Baseline to 12 Months.
Mean change was measured by letters gained or lost. A positive number is letters gained, and a negative number is letters lost.
Mean Change in Central Foveal Thickness (CFT) From Baseline to 6 Months and Baseline to 12 Months

Full Information

First Posted
July 25, 2011
Last Updated
August 23, 2019
Sponsor
University of California, San Diego
Collaborators
Genentech, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT01402544
Brief Title
Clinical Assessment Of Age-related Macular Degeneration Patients After Early Diagnosis and Treatment With Ranibizumab
Acronym
COMPASS
Official Title
Clinical Assessment Of Age-related Macular Degeneration Patients After Early Diagnosis and Treatment With Ranibizumab (COMPASS)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Terminated
Why Stopped
Per study sponsor decision.
Study Start Date
July 2011 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
Genentech, Inc.

4. Oversight

Data Monitoring Committee
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Macular Degeneration
Keywords
AMD, Choroidal neovascularization, Ranibizumab, Age-related Macular Degeneration, Genome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ranibizumab 0.5 mg
Arm Type
Other
Arm Description
Ranibizumab 0.5 mg Intravitreal Injection, monthly, open-label, for the duration of 1 year
Intervention Type
Drug
Intervention Name(s)
ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
0.5mg intravitreal injection, monthly for 12 months, or until BCVA returns to pre-wet AMD baseline.
Primary Outcome Measure Information:
Title
Number of Patients That Achieve Their Pre-wet Age-Related Macular Degeneration (AMD) Baseline Visual Acuity Within 12 Months
Description
PI is no longer affiliated with institution. All efforts were exhausted to obtain data from all sites for this study, but we only have access to data from UCSD site. Data from these participants is being reported here.
Time Frame
Baseline, Month 6 and Month 12
Secondary Outcome Measure Information:
Title
Mean Change in Best Corrected Visual Acuity (BCVA) From Baseline to 6 Months and Baseline to 12 Months.
Description
Mean change was measured by letters gained or lost. A positive number is letters gained, and a negative number is letters lost.
Time Frame
Baseline, Month 6 and Month 12
Title
Mean Change in Central Foveal Thickness (CFT) From Baseline to 6 Months and Baseline to 12 Months
Time Frame
Baseline, Month 6 and Month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry Ferreyra, MD
Organizational Affiliation
University of California, San Diego
Official's Role
Study Chair
Facility Information:
Facility Name
California Retina Consultants
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
Shiley Eye Center, UCSD
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
California Retina Consultants
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93103
Country
United States
Facility Name
Medical Center Ophthalmology Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs