Macular Degeneration
Conditions
Brief summary
Patients with low vision (visual acuity 20/400 or worse) were excluded from the large Phase III ranibizumab clinical trials. It is not known if treatment with ranibizumab results in improved visual function in such patients.Since ranibizumab has been shown to be the most effective therapy for exudative macular degeneration we propose to treat all patients in this study with monthly ranibizumab intravitreal injections. Patients will be assigned to one of two groups by the flip of a coin. Group #1 for heads and Group #2 for tails. Group #1 patients will be treated for 3 monthly injections of 0.5 mg of ranibizumab and then as needed therapy. Group #2 will be treated with 6 monthly injections of 0.5 mg of ranibizumab and then as needed therapy.
Detailed description
The duration of the study is up to 13 months. This includes up to 30 days during which tests will be performed before treatment. Only one eye will be chosen for the study. Patients can receive up to 12 injections of ranibizumab during this study (the first dose\[s\], plus additional doses \[re treatment as often as every 22 days\] if the doctor determines that additional doses are required). In addition to study drug injections. Several eye examinations and procedures will be performed to evaluate response to treatment. These include: visual acuity testing (eye chart), contrast sensitivity testing, reading speed testing, measurement of time to complete typical daily activities, measurement of the thickness of the central retina, measurement of your central visual field. On the screening visit and two more times during the study fluorescein angiography will be performed. The screening tests included the following: * A review of your medical history * A review of any medications you are or have been taking * Eye examinations, including visual acuity testing (reading letters on an eye chart) * Blood pressure measurement Woman of childbearing potential must also take a urine pregnancy test during the screening period to rule out pregnancy. Upon completion of the study at Month 12 and if it were to occur; early termination visit, the following procedures will be performed: vision exam,OCT,microperimetry,FA/Photos,VFQ,reading performance, contrast sensitivity and TIADL.
Interventions
DRUGranibizumab
Group 1 - 0.5mg intravitreal injection every month for 3 months then as needed for 12 months Group 2 -0.5mg intravitreal injection every month for 6 months then as needed for 12 months
Sponsors
Genentech, Inc.
California Pacific Medical Center
Pacific Eye Associates
Steven R. Sanislo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects will be eligible if the following criteria are met: * Ability to provide written informed consent and comply with study assessments for the full duration of the study. * Age \> 50 years. * Low vision AMD patients with a VA of 20/400 or worse. * Evidence of active exudation as manifested by subretinal or intraretinal fluid on OCT or fresh appearing subretinal hemorrhage on fundus examination.
Exclusion criteria
Subjects who meet any of the following criteria will be excluded from this study: * 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. * Concurrent eye disease in the study eye that could compromise visual acuity (e.g., diabetic retinopathy, advanced glaucoma).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Visual Acuity | 12 months | Change in vision from baseline measurement at 12 months. Standard ETDRS chart (80 letters) was used to determine visual acuity with test luminance of 45 cd/m \^2 at 8 feet. Number of correctly read letters were reported. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ranibizumab Group 1 Group 1: 3 monthly injections of 0.5mg then prn | 8 |
| Ranibizumab Group 2 Group 2: 6 monthly injecions of 0.5mg then prn | 12 |
| Total | 20 |
Baseline characteristics
| Characteristic | Total | Ranibizumab Group 1 | Ranibizumab Group 2 |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 20 Participants | 8 Participants | 12 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 83 years | 81 years | 84 years |
| Region of Enrollment United States | 20 participants | 8 participants | 12 participants |
| Sex: Female, Male Female | 11 Participants | 3 Participants | 8 Participants |
| Sex: Female, Male Male | 9 Participants | 5 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 8 | 4 / 12 |
| serious Total, serious adverse events | 0 / 8 | 0 / 12 |
Outcome results
Primary
Mean Change in Visual Acuity
Change in vision from baseline measurement at 12 months. Standard ETDRS chart (80 letters) was used to determine visual acuity with test luminance of 45 cd/m \^2 at 8 feet. Number of correctly read letters were reported.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ranibizumab Group 1 | Mean Change in Visual Acuity | 15.0 letters | Standard Deviation 14.2 |
| Ranibizumab Group 2 | Mean Change in Visual Acuity | 5.6 letters | Standard Deviation 8.6 |
p-value: 0.02t-test, 2 sided
p-value: 0.06t-test, 2 sided