Age-Related Macular Degeneration
Conditions
Keywords
AMD, Choroidal neovascularization, Ranibizumab, Age-related Macular Degeneration, Genome
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).
Interventions
DRUGranibizumab
0.5mg intravitreal injection, monthly for 12 months, or until BCVA returns to pre-wet AMD baseline.
Sponsors
Genentech, Inc.
University of California, San Diego
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients That Achieve Their Pre-wet Age-Related Macular Degeneration (AMD) Baseline Visual Acuity Within 12 Months | Baseline, Month 6 and Month 12 | 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
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Best Corrected Visual Acuity (BCVA) From Baseline to 6 Months and Baseline to 12 Months. | Baseline, Month 6 and Month 12 | 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 | Baseline, Month 6 and Month 12 | — |
Countries
United States
Participant flow
Pre-assignment details
The Principal Investigator 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.
Participants by arm
| Arm | Count |
|---|---|
| Ranibizumab 0.5 mg Ranibizumab 0.5 mg Intravitreal Injection, monthly, open-label, for the duration of 1 year
ranibizumab: 0.5mg intravitreal injection, monthly for 12 months, or until BCVA returns to pre-wet AMD baseline. | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | Ranibizumab 0.5 mg |
|---|---|
| Age, Continuous | 84.42 years STANDARD_DEVIATION 6.86 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 12 Participants |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 6 / 12 |
Outcome results
Primary
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.
Time frame: Baseline, Month 6 and Month 12
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ranibizumab 0.5 mg | Number of Patients That Achieve Their Pre-wet Age-Related Macular Degeneration (AMD) Baseline Visual Acuity Within 12 Months | 3 Participants |
Secondary
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.
Time frame: Baseline, Month 6 and Month 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ranibizumab 0.5 mg | Mean Change in Best Corrected Visual Acuity (BCVA) From Baseline to 6 Months and Baseline to 12 Months. | Change from Baseline to Month 6 | -3.333 letters | Standard Deviation 4.082 |
| Ranibizumab 0.5 mg | Mean Change in Best Corrected Visual Acuity (BCVA) From Baseline to 6 Months and Baseline to 12 Months. | Change from Baseline to Month 12 | -9.167 letters | Standard Deviation 9.174 |
Secondary
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
Population: 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.The CFT image for one participant could not be located, so only 5 of the 6 enrolled participants data are being reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ranibizumab 0.5 mg | Mean Change in Central Foveal Thickness (CFT) From Baseline to 6 Months and Baseline to 12 Months | Change from Baseline to Month 6 | -23.4 microns | Standard Deviation 25.126 |
| Ranibizumab 0.5 mg | Mean Change in Central Foveal Thickness (CFT) From Baseline to 6 Months and Baseline to 12 Months | Change from Baseline to Month 12 | -25.2 microns | Standard Deviation 21.029 |