Macular Degeneration
Conditions
Keywords
AMD, Macular Degeneration, bevasiranib, COBALT study, age related macular degeneration, wet AMD, wet age related macular degeneration
Brief summary
The purpose of this study is to compare the safety and effectiveness of bevasiranib given either every 8 weeks or every 12 weeks after an initial pre-treatment with 3 injections of Lucentis® (ranibizumab injection) compared to Lucentis® given every 4 weeks to people with wet AMD. Patients will be assigned at random (like tossing a coin) to receive one of three treatments options for 104 weeks.
Interventions
DRUGbevasiranib
Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks
DRUGranibizumab
Lucentis® (0.5 mg)administered intravitreally every 4 weeks.
Sponsors
OPKO Health, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients must be age 50 years or older 2. Patients must have predominantly classic, minimally classic or occult with no classic lesions secondary to Age Related Macular Degeneration. 3. The study eye must have ETDRS best corrected visual acuity of 69 to 24 letters (20/40 to 20/320 Snellen equivalent). 4. Patients must be willing and able to return for scheduled monthly follow-up visits for two-years.
Exclusion criteria
1. Prior pharmacologic treatment for AMD in the study (patients can not have previously received Avastin®/Lucentis®, Macugen®, or any other anti-VEGF agents, steroid treatments, PDT, radiation treatment, or any experimental therapies for AMD in the study eye) 2. Any intraocular surgery of the study eye within 12 weeks of screening 3. Previous posterior vitrectomy of the study eye 4. Advanced glaucoma or intraocular pressure above 22 mm Hg in the study eye despite treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity | week 60 | avoidance of 3 or more lines of vision loss |
Secondary
| Measure | Time frame |
|---|---|
| Need for Rescue Therapy, Time to Rescue Therapy, and Number of Patients With a 3 or More Line Gain in Vision | Week 60 |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lucentis Lucentis® (0.5mg) every 4 weeks.
ranibizumab: Lucentis® (0.5 mg)administered intravitreally every 4 weeks. | 113 |
| Bevasiranib 8 Weeks Bevasiranib (2.5mg) every 8 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6.
bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks | 112 |
| Bevasiranib 12 Weeks Bevasiranib (2.5mg) every 12 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6.
bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks | 113 |
| Total | 338 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Not treated | 1 | 0 | 1 |
| Overall Study | Study Terminated | 112 | 112 | 112 |
Baseline characteristics
| Characteristic | Lucentis | Bevasiranib 8 Weeks | Bevasiranib 12 Weeks | Total |
|---|---|---|---|---|
| Age, Continuous | 77.6 years | 77.2 years | 78.3 years | 77.7 years |
| Region of Enrollment Austria | 4 participants | 5 participants | 4 participants | 13 participants |
| Region of Enrollment Canada | 8 participants | 10 participants | 5 participants | 23 participants |
| Region of Enrollment France | 22 participants | 24 participants | 20 participants | 66 participants |
| Region of Enrollment Israel | 9 participants | 7 participants | 6 participants | 22 participants |
| Region of Enrollment Italy | 5 participants | 2 participants | 2 participants | 9 participants |
| Region of Enrollment Portugal | 3 participants | 3 participants | 5 participants | 11 participants |
| Region of Enrollment Spain | 1 participants | 2 participants | 7 participants | 10 participants |
| Region of Enrollment United States | 61 participants | 59 participants | 64 participants | 184 participants |
| Sex: Female, Male Female | 80 Participants | 72 Participants | 59 Participants | 211 Participants |
| Sex: Female, Male Male | 33 Participants | 40 Participants | 54 Participants | 127 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 71 / 112 | 85 / 112 | 96 / 112 |
| serious Total, serious adverse events | 26 / 112 | 28 / 112 | 33 / 112 |
Outcome results
Primary
Visual Acuity
avoidance of 3 or more lines of vision loss
Time frame: week 60
Population: Zero participants analyzed due to early termination of the study.
Secondary
Need for Rescue Therapy, Time to Rescue Therapy, and Number of Patients With a 3 or More Line Gain in Vision
Time frame: Week 60
Population: Zero participants analyzed due to early termination of the study.