Geographic Atrophy
Conditions
Brief summary
This is a multicenter, open-label extension study of safety and tolerability of lampalizumab administered by intravitreal (ITV) injection to participants with geographic atrophy (GA) who have completed the 18-month treatment in Study CFD4870g (GX01456) (NCT01229215) or 24-week treatment in Study GX29455 (NCT02288559).
Interventions
DRUGLampalizumab
Lampalizumab 10 mg ITV injections as per the schedule specified in respective arms.
Sponsors
Genentech, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* For CFD4870g participants: Previous enrollment and completion (Month 18 visit) of Study CFD4870g without early treatment discontinuation (lampalizumab or sham) * For GX29455 participants: Previous enrollment and completion (Week 24 visit) of Study GX29455 without early treatment discontinuation (lampalizumab or sham) * Sufficiently clear ocular media, adequate pupillary dilation, and fixation to permit quality fundus imaging
Exclusion criteria
* Early treatment and/or study discontinuation prior to completion of study CFD4870g (GX01456) and GX29455 * Vitrectomy surgery, submacular surgery, or other surgical intervention for age-related macular degeneration (AMD) in the study eye * Subfoveal focal laser photocoagulation in the study eye * Treatment with Visodyne, external-beam radiation therapy, or transpupillary thermotherapy in the study eye * Intravitreally (ITV) drug delivery (e.g., ITV corticosteroid injection, anti-angiogenic drugs, anticomplement drugs, or device implantation) in the study eye. Lampalizumab in study eye and ranibizumab in either eye are permitted * Any concurrent ocular or intraocular condition in the study eye that contraindicates the use of an investigational drug or may affect interpretation of the study results or may render the participant at high risk for treatment complications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Ocular and Non-ocular Adverse Events (AEs) | From Day 1 up to the last study visit (up to approximately 62 months) | An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test. Ocular AEs are events localized to the eye. Non-ocular events include all other events. |
Countries
Germany, United States
Participant flow
Recruitment details
This study enrolled eligible patients who had completed the 18-month treatment period of Study NCT01229215 (CFD4870g) or the 24-week treatment period of Study NCT02288559 (GX29455). The study was terminated early by the Sponsor due to lack of efficacy.
Participants by arm
| Arm | Count |
|---|---|
| CFD4870g Sham Participants who were administered sham comparator in Study NCT01229215 (CFD4870g), received lampalizumab 10 milligrams (mg), intravitreally (ITV), either once in every 4 weeks (Q4W) or once in every 8 weeks (Q8W) in accordance with their previously assigned treatment frequency assignment in Study CFD4870g followed by Q4W administration for the remainder of the extension study. | 29 |
| CFD4870g Lampalizumab Participants received lampalizumab 10 mg, ITV, Q4W or Q8W in accordance with their previously assigned treatment frequency assignment in Study NCT01229215 (CFD4870g) followed by Q4W administration for the remainder of the extension study. | 60 |
| GX29455 Sham Participants who were administered sham comparator in Study NCT02288559 (GX29455), received lampalizumab 10 mg, ITV, Q4W throughout the extension study. | 17 |
| GX29455 Lampalizumab Participants who were administered lampalizumab in Study NCT02288559 (GX29455), received lampalizumab 10 mg, ITV, Q4W throughout the extension study. | 53 |
| Total | 159 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 3 | 6 | 0 | 2 |
| Overall Study | Death | 0 | 4 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 1 |
| Overall Study | Non-compliance | 0 | 3 | 0 | 1 |
| Overall Study | Physician Decision | 2 | 3 | 0 | 0 |
| Overall Study | Protocol Violation | 1 | 1 | 0 | 0 |
| Overall Study | Study Terminated by Sponsor | 12 | 24 | 17 | 44 |
| Overall Study | Unspecified Reason | 3 | 1 | 0 | 2 |
| Overall Study | Withdrawal by Subject | 8 | 17 | 0 | 3 |
Baseline characteristics
| Characteristic | Total | GX29455 Lampalizumab | CFD4870g Sham | GX29455 Sham | CFD4870g Lampalizumab |
|---|---|---|---|---|---|
| Age, Continuous | 79.1 years STANDARD_DEVIATION 7 | 79.5 years STANDARD_DEVIATION 7.6 | 79.4 years STANDARD_DEVIATION 6.6 | 76.7 years STANDARD_DEVIATION 6.6 | 79.4 years STANDARD_DEVIATION 6.8 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 157 Participants | 52 Participants | 29 Participants | 17 Participants | 59 Participants |
| Race/Ethnicity, Customized White | 156 Participants | 53 Participants | 29 Participants | 15 Participants | 59 Participants |
| Sex: Female, Male Female | 89 Participants | 27 Participants | 17 Participants | 12 Participants | 33 Participants |
| Sex: Female, Male Male | 70 Participants | 26 Participants | 12 Participants | 5 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 29 | 6 / 60 | 0 / 17 | 1 / 53 | 8 / 159 |
| other Total, other adverse events | 24 / 29 | 56 / 60 | 16 / 17 | 41 / 53 | 137 / 159 |
| serious Total, serious adverse events | 16 / 29 | 40 / 60 | 5 / 17 | 9 / 53 | 70 / 159 |
Outcome results
Primary
Percentage of Participants With Ocular and Non-ocular Adverse Events (AEs)
An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test. Ocular AEs are events localized to the eye. Non-ocular events include all other events.
Time frame: From Day 1 up to the last study visit (up to approximately 62 months)
Population: Safety population included all participants who were enrolled and received at least one lampalizumab injection in the extension study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CFD4870g Sham | Percentage of Participants With Ocular and Non-ocular Adverse Events (AEs) | Non-Ocular AEs | 79.3 percentage of participants |
| CFD4870g Sham | Percentage of Participants With Ocular and Non-ocular Adverse Events (AEs) | Ocular AEs in Fellow Eye | 62.1 percentage of participants |
| CFD4870g Sham | Percentage of Participants With Ocular and Non-ocular Adverse Events (AEs) | Ocular AEs in Study Eye | 62.1 percentage of participants |
| CFD4870g Lampalizumab | Percentage of Participants With Ocular and Non-ocular Adverse Events (AEs) | Ocular AEs in Study Eye | 78.3 percentage of participants |
| CFD4870g Lampalizumab | Percentage of Participants With Ocular and Non-ocular Adverse Events (AEs) | Non-Ocular AEs | 90.0 percentage of participants |
| CFD4870g Lampalizumab | Percentage of Participants With Ocular and Non-ocular Adverse Events (AEs) | Ocular AEs in Fellow Eye | 68.3 percentage of participants |
| GX29455 Sham | Percentage of Participants With Ocular and Non-ocular Adverse Events (AEs) | Ocular AEs in Study Eye | 52.9 percentage of participants |
| GX29455 Sham | Percentage of Participants With Ocular and Non-ocular Adverse Events (AEs) | Ocular AEs in Fellow Eye | 29.4 percentage of participants |
| GX29455 Sham | Percentage of Participants With Ocular and Non-ocular Adverse Events (AEs) | Non-Ocular AEs | 82.4 percentage of participants |
| GX29455 Lampalizumab | Percentage of Participants With Ocular and Non-ocular Adverse Events (AEs) | Ocular AEs in Fellow Eye | 60.4 percentage of participants |
| GX29455 Lampalizumab | Percentage of Participants With Ocular and Non-ocular Adverse Events (AEs) | Ocular AEs in Study Eye | 50.9 percentage of participants |
| GX29455 Lampalizumab | Percentage of Participants With Ocular and Non-ocular Adverse Events (AEs) | Non-Ocular AEs | 67.9 percentage of participants |
| All Participants | Percentage of Participants With Ocular and Non-ocular Adverse Events (AEs) | Ocular AEs in Fellow Eye | 60.4 percentage of participants |
| All Participants | Percentage of Participants With Ocular and Non-ocular Adverse Events (AEs) | Ocular AEs in Study Eye | 63.5 percentage of participants |
| All Participants | Percentage of Participants With Ocular and Non-ocular Adverse Events (AEs) | Non-Ocular AEs | 79.9 percentage of participants |