Geographic Atrophy
Conditions
Keywords
Geographic atrophy (GA), Macular degeneration, Dry age-related macular degeneration (AMD), Intravitreal (IVT), Retinal diseases, Fundus auto fluorescence (FAF)
Brief summary
The purpose of this study is to evaluate the safety and efficacy of 12 (every 28 days) intravitreal (IVT) injections of CLG561 as a monotherapy and in combination with LFG316 as compared to sham in subjects with geographic atrophy.
Detailed description
This study consists of an up-to 30-day screening period, an approximately 336-day treatment period, and a follow-up period consisting of two visits occurring 4 and 16 weeks after the last administered injection.
Interventions
Sponsors
Novartis Institutes for BioMedical Research
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Sign written informed consent form; * Geographic atrophy in both eyes; * Other protocol-specified inclusion criteria may apply.
Exclusion criteria
* Pregnant or lactating women and women of child-bearing potential; * Any medical condition (systemic or ophthalmic) that may preclude the safe administration of test article or safe participation in this study; * Any contraindications or hypersensitivities to any component of the LFG316 or CLG561 solution; * Any contraindications to IVT injections; * Ocular surgery in either eye within 90 days of screening; * Uncontrolled ocular hypertension or glaucoma in the study eye; * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With a Serious Adverse Event That, in the Opinion of the Investigator, is Related to the Study Drug | Up to Day 421 | A serious adverse event (SAE) was defined as any adverse experience that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. All SAEs related to the study drug are reported. No statistical analysis was conducted. |
| Mean Change From Baseline in Intraocular Pressure (IOP) | Baseline (Day 1), Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 197, Day 225, Day 253, Day 281, Day 309 | IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry and reported in millimeters of mercury (mmHg). A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). Baseline is defined as the last measurement prior to first dose of treatment. A more negative change indicates a greater amount of improvement. One eye (study eye) contributed to the analysis. No statistical analysis was conducted. |
| Change in GA Lesion Size From Baseline to Day 337 as Measured by Fundus Autofluorescence (FAF) | Baseline (Day 1), Day 337 | Geographic atrophy, also known as atrophic age-related macular degeneration (AMD) or advanced dry AMD, is an advanced form of age-related macular degeneration that can result in the progressive and irreversible loss of retina which can lead to a loss of visual function over time. Geographic atrophy (GA) lesion size was assessed by a Central Reading Center (CRC) using FAF. Baseline is defined as the last measurement prior to first dose of treatment. One eye (study eye) contributed to the analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Low Luminance Visual Acuity (LLVA) From Baseline up to Day 337 as Measured by ETDRS | Baseline (Day 1), Day 2, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 197, Day 225, Day 253, Day 281, Day 309, Day 337 | Low Luminance Visual Acuity (VA) was assessed using ETDRS testing at 4 meters with a neutral density filter to reduce chart luminance to 3 candelas/m2. Baseline is defined as the last measurement prior to first dose of treatment. BCVA change was defined as a change in letters read from the baseline assessment. A positive change value indicates improvement. One eye (study eye) contributed to the analysis. |
| Change in LLVA Deficit From Baseline up to Day 337 as Measured by ETDRS | Baseline (Day 1), Day 2, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 197, Day 225, Day 253, Day 281, Day 309, Day 337 | Low Luminance Visual Acuity (VA) was assessed using ETDRS testing at 4 meters with a neutral density filter to reduce chart luminance to 3 candelas/m2. A deficit in LLVA is defined as a loss in letters read from baseline. Baseline is defined as the last measurement prior to first dose of treatment. A negative change value indicates improvement (more letters read). One eye (study eye) contributed to the analysis. |
| Average Change in BCVA From Baseline to the Period Day 281 to Day 337 as Measured by ETDRS | Baseline (Day 1), Day 281, Day 309, Day 337 | BCVA was assessed using ETDRS testing at 4 meters. Day 281, Day 309, and Day 337 were averaged and compared to baseline. BCVA change was defined as a change in letters read from the baseline assessment. A positive change value indicates improvement. One eye (study eye) contributed to the analysis. No statistical analysis was conducted. |
| Average Change in LLVA From Baseline to the Period Day 281 to Day 337 as Measured by ETDRS | Baseline (Day 1), Day 281, Day 309, Day 337 | LLVA was assessed at 4 meters using a neutral density filter to reduce chart luminance to 3 candelas/m2. Baseline is defined as the last measurement prior to first dose of treatment. Day 281, Day 309, and Day 337 were averaged and compared to baseline. BCVA change was defined as a change in letters read from the baseline assessment. A positive change value indicates improvement. One eye (study eye) contributed to the analysis. No statistical analysis was conducted. |
| Average LLVA Deficit (Letters) Change From Baseline at Day 281 to Day 337 as Measured by ETDRS | Baseline (Day 1), Day 281, Day 309, Day 337 | LLVA was assessed at 4 meters using a neutral density filter to reduce chart luminance to 3 candelas/m2. A deficit in LLVA is defined as a loss in letters read from baseline. Baseline is defined as the last measurement prior to first dose of treatment. Day 281, Day 309, and Day 337 were averaged and compared to baseline. A negative change value indicates improvement (more letters read). One eye (study eye) contributed to the analysis. |
| Change in GA Lesion Size From Baseline to Day 85, 169, and 253 as Measured by FAF | Baseline (Day 1), Day 85, Day 169, Day 253 | Geographic atrophy, also known as atrophic age-related macular degeneration (AMD) or advanced dry AMD, is an advanced form of age-related macular degeneration that can result in the progressive and irreversible loss of retina which can lead to a loss of visual function over time. Geographic atrophy (GA) lesion size was assessed by a Central Reading Center (CRC) using FAF. Baseline is defined as the last measurement prior to first dose of treatment. One eye (study eye) contributed to the analysis. |
| Total CLG561 Serum Concentrations up to Day 421 | Baseline (Day 1), Day 2, Day 8, Day 15, Day 29, Day 85, Day 169, Day 253, Day 309, Day 337, Day 421 | Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. |
| Total LFG316 Serum Concentration up to Day 421 | Baseline (Day 1), Day 337, Day 421 | Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. |
| Percentage of Subjects With Anti-CLG561 Antibodies up to Day 421 | Baseline (Day 1), up to Day 421 | Samples were collected and assessed for anti-CLG561 antibodies. |
| Percentage of Subjects With Anti-LFG316 Antibodies up to Day 421 | Baseline (Day 1), up to Day 421 | Samples were collected and assessed for anti-LFG316 antibodies. |
| Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Baseline (Day 1), Day 2, Day 8, Day 15, Day 29, Day 30, Day 57, Day 85, Day 113, Day 141, Day 169, Day 197, Day 225, Day 253, Day 281, Day 309, Day 337 | BCVA was assessed using ETDRS testing at 4 meters. Baseline is defined as the last measurement prior to first dose of treatment. BCVA change was defined as a change in letters read from the baseline assessment and is reported categorically. One eye (study eye) contributed to the analysis. No statistical analysis was conducted. |
| Mean Change in GA Lesion Size From Baseline to Day 421 as Measured by FAF | Baseline (Day 1), Day 421 | Geographic atrophy, also known as atrophic age-related macular degeneration (AMD) or advanced dry AMD, is an advanced form of age-related macular degeneration that can result in the progressive and irreversible loss of retina which can lead to a loss of visual function over time. Geographic atrophy (GA) lesion size was assessed by a Central Reading Center (CRC) using FAF. Baseline is defined as the last measurement prior to first dose of treatment. One eye (study eye) contributed to the analysis. Day 421 measurements were only summarized descriptively and did not include any statistical modeling. |
| Change in Best Corrected Visual Acuity (BCVA) From Baseline by Visit up to Day 337 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) | Baseline (Day 1), Day 2, Day 8, Day 15, Day 29, Day 30, Day 57, Day 85, Day 113, Day 141, Day 169, Day 197, Day 225, Day 253, Day 281, Day 309, Day 337 | BCVA was assessed using ETDRS testing at 4 meters. Baseline is defined as the last measurement prior to first dose of treatment. BCVA change was defined as a change in letters read from the baseline assessment. A positive change value indicates improvement. One eye (study eye) contributed to the analysis. |
Participant flow
Recruitment details
Subjects were recruited from 28 sites in the US and Puerto Rico.
Pre-assignment details
This reporting group includes all randomized participants.
Participants by arm
| Arm | Count |
|---|---|
| CLG561 CLG561 10 mg, one IVT injection every 28 days for a total of 12 injections | 36 |
| CLG561+LFG316 CLG561 5 mg + LFG316 5 mg, one IVT injection every 28 days for a total of 12 injections | 39 |
| Sham Injection One sham injection every 28 days for total of 12 sham injections | 39 |
| Total | 114 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 5 | 0 | 0 |
| Overall Study | Death | 0 | 0 | 1 |
| Overall Study | Lack of Efficacy | 0 | 0 | 1 |
| Overall Study | Lost to Follow-up | 2 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 3 | 2 |
Baseline characteristics
| Characteristic | CLG561 | CLG561+LFG316 | Sham Injection | Total |
|---|---|---|---|---|
| Age, Continuous | 77.7 years STANDARD_DEVIATION 8.61 | 78.8 years STANDARD_DEVIATION 7.11 | 78.7 years STANDARD_DEVIATION 9.8 | 78.4 years STANDARD_DEVIATION 8.52 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 3 Participants | 5 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 31 Participants | 35 Participants | 33 Participants | 99 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 38 Participants | 38 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 35 Participants | 39 Participants | 0 Participants | 74 Participants |
| Sex: Female, Male Female | 22 Participants | 21 Participants | 24 Participants | 67 Participants |
| Sex: Female, Male Male | 14 Participants | 18 Participants | 15 Participants | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 36 | 0 / 39 | 1 / 39 |
| other Total, other adverse events | 27 / 36 | 31 / 39 | 29 / 39 |
| serious Total, serious adverse events | 5 / 36 | 5 / 39 | 7 / 39 |
Outcome results
Primary
Change in GA Lesion Size From Baseline to Day 337 as Measured by Fundus Autofluorescence (FAF)
Geographic atrophy, also known as atrophic age-related macular degeneration (AMD) or advanced dry AMD, is an advanced form of age-related macular degeneration that can result in the progressive and irreversible loss of retina which can lead to a loss of visual function over time. Geographic atrophy (GA) lesion size was assessed by a Central Reading Center (CRC) using FAF. Baseline is defined as the last measurement prior to first dose of treatment. One eye (study eye) contributed to the analysis.
Time frame: Baseline (Day 1), Day 337
Population: PPS. Only subjects with a value at both baseline and that time point are included.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| CLG561 | Change in GA Lesion Size From Baseline to Day 337 as Measured by Fundus Autofluorescence (FAF) | 1.53 square millimeters (mm2) |
| CLG561+LFG316 | Change in GA Lesion Size From Baseline to Day 337 as Measured by Fundus Autofluorescence (FAF) | 1.88 square millimeters (mm2) |
| Sham Injection | Change in GA Lesion Size From Baseline to Day 337 as Measured by Fundus Autofluorescence (FAF) | 1.82 square millimeters (mm2) |
p-value: 0.063680% CI: [-0.64, -0.06]ANCOVA
Comparison: Least squares mean for change from baseline from ANCOVA model with treatment, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal), baseline lesion size as covariates after multiple imputations.p-value: 0.101980% CI: [-0.59, 0]ANCOVA
Comparison: Least squares mean for change from baseline from ANCOVA model with treatment, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal), baseline lesion size as covariates after multiple imputations.p-value: 0.598780% CI: [-0.24, 0.35]ANCOVA
Primary
Mean Change From Baseline in Intraocular Pressure (IOP)
IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry and reported in millimeters of mercury (mmHg). A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). Baseline is defined as the last measurement prior to first dose of treatment. A more negative change indicates a greater amount of improvement. One eye (study eye) contributed to the analysis. No statistical analysis was conducted.
Time frame: Baseline (Day 1), Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 197, Day 225, Day 253, Day 281, Day 309
Population: Safety Analysis Set. At each time point, only subjects with a value at both baseline and that time point are included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CLG561 | Mean Change From Baseline in Intraocular Pressure (IOP) | Baseline (BL) (Day 1) | 15.1 mmHg | Standard Deviation 3.58 |
| CLG561 | Mean Change From Baseline in Intraocular Pressure (IOP) | Change from BL at Day 29 | -0.2 mmHg | Standard Deviation 2.57 |
| CLG561 | Mean Change From Baseline in Intraocular Pressure (IOP) | Change from BL at Day 57 | -0.2 mmHg | Standard Deviation 3.46 |
| CLG561 | Mean Change From Baseline in Intraocular Pressure (IOP) | Change from BL at Day 85 | -0.1 mmHg | Standard Deviation 2.8 |
| CLG561 | Mean Change From Baseline in Intraocular Pressure (IOP) | Change from BL at Day 113 | 0.2 mmHg | Standard Deviation 3.84 |
| CLG561 | Mean Change From Baseline in Intraocular Pressure (IOP) | Change from BL at Day 141 | 0.4 mmHg | Standard Deviation 2.93 |
| CLG561 | Mean Change From Baseline in Intraocular Pressure (IOP) | Change from BL at Day 169 | 0.4 mmHg | Standard Deviation 4.35 |
| CLG561 | Mean Change From Baseline in Intraocular Pressure (IOP) | Change from BL at Day 197 | -0.4 mmHg | Standard Deviation 3.88 |
| CLG561 | Mean Change From Baseline in Intraocular Pressure (IOP) | Change from BL at Day 225 | -0.3 mmHg | Standard Deviation 3.72 |
| CLG561 | Mean Change From Baseline in Intraocular Pressure (IOP) | Change from BL at Day 253 | 0.6 mmHg | Standard Deviation 4.39 |
| CLG561 | Mean Change From Baseline in Intraocular Pressure (IOP) | Change from BL at Day 281 | 1.6 mmHg | Standard Deviation 8.32 |
| CLG561 | Mean Change From Baseline in Intraocular Pressure (IOP) | Change from BL at Day 309 | 1.0 mmHg | Standard Deviation 2.97 |
| CLG561+LFG316 | Mean Change From Baseline in Intraocular Pressure (IOP) | Change from BL at Day 309 | 0.0 mmHg | Standard Deviation 3.43 |
| CLG561+LFG316 | Mean Change From Baseline in Intraocular Pressure (IOP) | Baseline (BL) (Day 1) | 14.5 mmHg | Standard Deviation 3.42 |
| CLG561+LFG316 | Mean Change From Baseline in Intraocular Pressure (IOP) | Change from BL at Day 169 | -0.1 mmHg | Standard Deviation 3.33 |
| CLG561+LFG316 | Mean Change From Baseline in Intraocular Pressure (IOP) | Change from BL at Day 225 | -0.0 mmHg | Standard Deviation 4.11 |
| CLG561+LFG316 | Mean Change From Baseline in Intraocular Pressure (IOP) | Change from BL at Day 29 | 0.0 mmHg | Standard Deviation 2.95 |
| CLG561+LFG316 | Mean Change From Baseline in Intraocular Pressure (IOP) | Change from BL at Day 141 | 0.1 mmHg | Standard Deviation 3.82 |
| CLG561+LFG316 | Mean Change From Baseline in Intraocular Pressure (IOP) | Change from BL at Day 281 | 0.5 mmHg | Standard Deviation 3.72 |
| CLG561+LFG316 | Mean Change From Baseline in Intraocular Pressure (IOP) | Change from BL at Day 57 | -0.4 mmHg | Standard Deviation 2.7 |
| CLG561+LFG316 | Mean Change From Baseline in Intraocular Pressure (IOP) | Change from BL at Day 197 | -0.0 mmHg | Standard Deviation 3.74 |
| CLG561+LFG316 | Mean Change From Baseline in Intraocular Pressure (IOP) | Change from BL at Day 113 | 0.4 mmHg | Standard Deviation 3.31 |
| CLG561+LFG316 | Mean Change From Baseline in Intraocular Pressure (IOP) | Change from BL at Day 85 | -0.1 mmHg | Standard Deviation 3.02 |
| CLG561+LFG316 | Mean Change From Baseline in Intraocular Pressure (IOP) | Change from BL at Day 253 | -0.2 mmHg | Standard Deviation 3.61 |
| Sham Injection | Mean Change From Baseline in Intraocular Pressure (IOP) | Change from BL at Day 85 | 0.2 mmHg | Standard Deviation 2.86 |
| Sham Injection | Mean Change From Baseline in Intraocular Pressure (IOP) | Change from BL at Day 113 | -0.7 mmHg | Standard Deviation 2.69 |
| Sham Injection | Mean Change From Baseline in Intraocular Pressure (IOP) | Change from BL at Day 253 | -1.1 mmHg | Standard Deviation 3.75 |
| Sham Injection | Mean Change From Baseline in Intraocular Pressure (IOP) | Change from BL at Day 141 | -0.6 mmHg | Standard Deviation 3.09 |
| Sham Injection | Mean Change From Baseline in Intraocular Pressure (IOP) | Change from BL at Day 169 | -0.6 mmHg | Standard Deviation 3.75 |
| Sham Injection | Mean Change From Baseline in Intraocular Pressure (IOP) | Change from BL at Day 197 | -0.2 mmHg | Standard Deviation 3.13 |
| Sham Injection | Mean Change From Baseline in Intraocular Pressure (IOP) | Change from BL at Day 281 | -0.6 mmHg | Standard Deviation 3.91 |
| Sham Injection | Mean Change From Baseline in Intraocular Pressure (IOP) | Baseline (BL) (Day 1) | 15.5 mmHg | Standard Deviation 3.54 |
| Sham Injection | Mean Change From Baseline in Intraocular Pressure (IOP) | Change from BL at Day 29 | -0.7 mmHg | Standard Deviation 3.74 |
| Sham Injection | Mean Change From Baseline in Intraocular Pressure (IOP) | Change from BL at Day 225 | -0.4 mmHg | Standard Deviation 3.4 |
| Sham Injection | Mean Change From Baseline in Intraocular Pressure (IOP) | Change from BL at Day 57 | -0.1 mmHg | Standard Deviation 3.06 |
| Sham Injection | Mean Change From Baseline in Intraocular Pressure (IOP) | Change from BL at Day 309 | -1.2 mmHg | Standard Deviation 4 |
Primary
Number of Subjects With a Serious Adverse Event That, in the Opinion of the Investigator, is Related to the Study Drug
A serious adverse event (SAE) was defined as any adverse experience that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. All SAEs related to the study drug are reported. No statistical analysis was conducted.
Time frame: Up to Day 421
Population: Safety Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CLG561 | Number of Subjects With a Serious Adverse Event That, in the Opinion of the Investigator, is Related to the Study Drug | 0 subjects |
| CLG561+LFG316 | Number of Subjects With a Serious Adverse Event That, in the Opinion of the Investigator, is Related to the Study Drug | 0 subjects |
| Sham Injection | Number of Subjects With a Serious Adverse Event That, in the Opinion of the Investigator, is Related to the Study Drug | 0 subjects |
Secondary
Average Change in BCVA From Baseline to the Period Day 281 to Day 337 as Measured by ETDRS
BCVA was assessed using ETDRS testing at 4 meters. Day 281, Day 309, and Day 337 were averaged and compared to baseline. BCVA change was defined as a change in letters read from the baseline assessment. A positive change value indicates improvement. One eye (study eye) contributed to the analysis. No statistical analysis was conducted.
Time frame: Baseline (Day 1), Day 281, Day 309, Day 337
Population: PPS. At each time point, only subjects with a value at both baseline and that time point are included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CLG561 | Average Change in BCVA From Baseline to the Period Day 281 to Day 337 as Measured by ETDRS | 3.0 letters | Standard Deviation 11.5 |
| CLG561+LFG316 | Average Change in BCVA From Baseline to the Period Day 281 to Day 337 as Measured by ETDRS | 2.3 letters | Standard Deviation 13.25 |
| Sham Injection | Average Change in BCVA From Baseline to the Period Day 281 to Day 337 as Measured by ETDRS | -0.3 letters | Standard Deviation 11.23 |
Secondary
Average Change in LLVA From Baseline to the Period Day 281 to Day 337 as Measured by ETDRS
LLVA was assessed at 4 meters using a neutral density filter to reduce chart luminance to 3 candelas/m2. Baseline is defined as the last measurement prior to first dose of treatment. Day 281, Day 309, and Day 337 were averaged and compared to baseline. BCVA change was defined as a change in letters read from the baseline assessment. A positive change value indicates improvement. One eye (study eye) contributed to the analysis. No statistical analysis was conducted.
Time frame: Baseline (Day 1), Day 281, Day 309, Day 337
Population: PPS. At each time point, only subjects with a value at both baseline and that time point are included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CLG561 | Average Change in LLVA From Baseline to the Period Day 281 to Day 337 as Measured by ETDRS | 3.6 letters | Standard Deviation 11.04 |
| CLG561+LFG316 | Average Change in LLVA From Baseline to the Period Day 281 to Day 337 as Measured by ETDRS | 0.4 letters | Standard Deviation 10.8 |
| Sham Injection | Average Change in LLVA From Baseline to the Period Day 281 to Day 337 as Measured by ETDRS | -2.2 letters | Standard Deviation 17.01 |
Secondary
Average LLVA Deficit (Letters) Change From Baseline at Day 281 to Day 337 as Measured by ETDRS
LLVA was assessed at 4 meters using a neutral density filter to reduce chart luminance to 3 candelas/m2. A deficit in LLVA is defined as a loss in letters read from baseline. Baseline is defined as the last measurement prior to first dose of treatment. Day 281, Day 309, and Day 337 were averaged and compared to baseline. A negative change value indicates improvement (more letters read). One eye (study eye) contributed to the analysis.
Time frame: Baseline (Day 1), Day 281, Day 309, Day 337
Population: PPS. At each time point, only subjects with a value at both baseline and that time point are included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CLG561 | Average LLVA Deficit (Letters) Change From Baseline at Day 281 to Day 337 as Measured by ETDRS | -0.6 letters | Standard Deviation 8.91 |
| CLG561+LFG316 | Average LLVA Deficit (Letters) Change From Baseline at Day 281 to Day 337 as Measured by ETDRS | 1.9 letters | Standard Deviation 12.96 |
| Sham Injection | Average LLVA Deficit (Letters) Change From Baseline at Day 281 to Day 337 as Measured by ETDRS | 1.9 letters | Standard Deviation 16.82 |
Secondary
Change in Best Corrected Visual Acuity (BCVA) From Baseline by Visit up to Day 337 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS)
BCVA was assessed using ETDRS testing at 4 meters. Baseline is defined as the last measurement prior to first dose of treatment. BCVA change was defined as a change in letters read from the baseline assessment. A positive change value indicates improvement. One eye (study eye) contributed to the analysis.
Time frame: Baseline (Day 1), Day 2, Day 8, Day 15, Day 29, Day 30, Day 57, Day 85, Day 113, Day 141, Day 169, Day 197, Day 225, Day 253, Day 281, Day 309, Day 337
Population: FAS. At each time point, only subjects with a value at both baseline and that time point are included.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| CLG561 | Change in Best Corrected Visual Acuity (BCVA) From Baseline by Visit up to Day 337 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) | Change from BL at Day 29 | 3.28 letters |
| CLG561 | Change in Best Corrected Visual Acuity (BCVA) From Baseline by Visit up to Day 337 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) | Change from BL at Day 2 | -0.93 letters |
| CLG561 | Change in Best Corrected Visual Acuity (BCVA) From Baseline by Visit up to Day 337 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) | Change from BL at Day 8 | 2.14 letters |
| CLG561 | Change in Best Corrected Visual Acuity (BCVA) From Baseline by Visit up to Day 337 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) | Change from BL at Day 15 | 2.89 letters |
| CLG561 | Change in Best Corrected Visual Acuity (BCVA) From Baseline by Visit up to Day 337 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) | Change from BL at Day 30 | 3.30 letters |
| CLG561 | Change in Best Corrected Visual Acuity (BCVA) From Baseline by Visit up to Day 337 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) | Change from BL at Day 57 | 3.65 letters |
| CLG561 | Change in Best Corrected Visual Acuity (BCVA) From Baseline by Visit up to Day 337 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) | Change from BL at Day 85 | 3.86 letters |
| CLG561 | Change in Best Corrected Visual Acuity (BCVA) From Baseline by Visit up to Day 337 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) | Change from BL at Day 113 | 3.09 letters |
| CLG561 | Change in Best Corrected Visual Acuity (BCVA) From Baseline by Visit up to Day 337 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) | Change from BL at Day 141 | 3.20 letters |
| CLG561 | Change in Best Corrected Visual Acuity (BCVA) From Baseline by Visit up to Day 337 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) | Change from BL at Day 169 | 2.62 letters |
| CLG561 | Change in Best Corrected Visual Acuity (BCVA) From Baseline by Visit up to Day 337 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) | Change from BL at Day 197 | 2.30 letters |
| CLG561 | Change in Best Corrected Visual Acuity (BCVA) From Baseline by Visit up to Day 337 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) | Change from BL at Day 225 | 2.98 letters |
| CLG561 | Change in Best Corrected Visual Acuity (BCVA) From Baseline by Visit up to Day 337 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) | Change from BL at Day 253 | 2.76 letters |
| CLG561 | Change in Best Corrected Visual Acuity (BCVA) From Baseline by Visit up to Day 337 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) | Change from BL at Day 281 | 1.52 letters |
| CLG561 | Change in Best Corrected Visual Acuity (BCVA) From Baseline by Visit up to Day 337 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) | Change from BL at Day 309 | 1.39 letters |
| CLG561 | Change in Best Corrected Visual Acuity (BCVA) From Baseline by Visit up to Day 337 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) | Change from BL at Day 337 | 0.25 letters |
| CLG561+LFG316 | Change in Best Corrected Visual Acuity (BCVA) From Baseline by Visit up to Day 337 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) | Change from BL at Day 57 | 4.69 letters |
| CLG561+LFG316 | Change in Best Corrected Visual Acuity (BCVA) From Baseline by Visit up to Day 337 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) | Change from BL at Day 85 | 2.57 letters |
| CLG561+LFG316 | Change in Best Corrected Visual Acuity (BCVA) From Baseline by Visit up to Day 337 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) | Change from BL at Day 113 | 3.60 letters |
| CLG561+LFG316 | Change in Best Corrected Visual Acuity (BCVA) From Baseline by Visit up to Day 337 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) | Change from BL at Day 281 | 2.08 letters |
| CLG561+LFG316 | Change in Best Corrected Visual Acuity (BCVA) From Baseline by Visit up to Day 337 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) | Change from BL at Day 141 | 5.14 letters |
| CLG561+LFG316 | Change in Best Corrected Visual Acuity (BCVA) From Baseline by Visit up to Day 337 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) | Change from BL at Day 169 | 3.57 letters |
| CLG561+LFG316 | Change in Best Corrected Visual Acuity (BCVA) From Baseline by Visit up to Day 337 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) | Change from BL at Day 337 | 0.07 letters |
| CLG561+LFG316 | Change in Best Corrected Visual Acuity (BCVA) From Baseline by Visit up to Day 337 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) | Change from BL at Day 197 | 2.60 letters |
| CLG561+LFG316 | Change in Best Corrected Visual Acuity (BCVA) From Baseline by Visit up to Day 337 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) | Change from BL at Day 309 | 2.92 letters |
| CLG561+LFG316 | Change in Best Corrected Visual Acuity (BCVA) From Baseline by Visit up to Day 337 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) | Change from BL at Day 2 | 1.79 letters |
| CLG561+LFG316 | Change in Best Corrected Visual Acuity (BCVA) From Baseline by Visit up to Day 337 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) | Change from BL at Day 225 | 3.33 letters |
| CLG561+LFG316 | Change in Best Corrected Visual Acuity (BCVA) From Baseline by Visit up to Day 337 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) | Change from BL at Day 8 | 2.46 letters |
| CLG561+LFG316 | Change in Best Corrected Visual Acuity (BCVA) From Baseline by Visit up to Day 337 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) | Change from BL at Day 15 | 4.83 letters |
| CLG561+LFG316 | Change in Best Corrected Visual Acuity (BCVA) From Baseline by Visit up to Day 337 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) | Change from BL at Day 29 | 5.29 letters |
| CLG561+LFG316 | Change in Best Corrected Visual Acuity (BCVA) From Baseline by Visit up to Day 337 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) | Change from BL at Day 30 | 3.16 letters |
| CLG561+LFG316 | Change in Best Corrected Visual Acuity (BCVA) From Baseline by Visit up to Day 337 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) | Change from BL at Day 253 | 3.31 letters |
| Sham Injection | Change in Best Corrected Visual Acuity (BCVA) From Baseline by Visit up to Day 337 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) | Change from BL at Day 197 | 3.54 letters |
| Sham Injection | Change in Best Corrected Visual Acuity (BCVA) From Baseline by Visit up to Day 337 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) | Change from BL at Day 57 | 4.25 letters |
| Sham Injection | Change in Best Corrected Visual Acuity (BCVA) From Baseline by Visit up to Day 337 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) | Change from BL at Day 253 | 0.46 letters |
| Sham Injection | Change in Best Corrected Visual Acuity (BCVA) From Baseline by Visit up to Day 337 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) | Change from BL at Day 309 | -0.75 letters |
| Sham Injection | Change in Best Corrected Visual Acuity (BCVA) From Baseline by Visit up to Day 337 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) | Change from BL at Day 85 | 3.05 letters |
| Sham Injection | Change in Best Corrected Visual Acuity (BCVA) From Baseline by Visit up to Day 337 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) | Change from BL at Day 337 | 0.45 letters |
| Sham Injection | Change in Best Corrected Visual Acuity (BCVA) From Baseline by Visit up to Day 337 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) | Change from BL at Day 15 | 3.02 letters |
| Sham Injection | Change in Best Corrected Visual Acuity (BCVA) From Baseline by Visit up to Day 337 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) | Change from BL at Day 113 | 3.40 letters |
| Sham Injection | Change in Best Corrected Visual Acuity (BCVA) From Baseline by Visit up to Day 337 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) | Change from BL at Day 2 | -1.44 letters |
| Sham Injection | Change in Best Corrected Visual Acuity (BCVA) From Baseline by Visit up to Day 337 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) | Change from BL at Day 30 | 2.92 letters |
| Sham Injection | Change in Best Corrected Visual Acuity (BCVA) From Baseline by Visit up to Day 337 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) | Change from BL at Day 141 | 2.22 letters |
| Sham Injection | Change in Best Corrected Visual Acuity (BCVA) From Baseline by Visit up to Day 337 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) | Change from BL at Day 281 | 0.67 letters |
| Sham Injection | Change in Best Corrected Visual Acuity (BCVA) From Baseline by Visit up to Day 337 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) | Change from BL at Day 29 | 1.25 letters |
| Sham Injection | Change in Best Corrected Visual Acuity (BCVA) From Baseline by Visit up to Day 337 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) | Change from BL at Day 169 | 3.61 letters |
| Sham Injection | Change in Best Corrected Visual Acuity (BCVA) From Baseline by Visit up to Day 337 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) | Change from BL at Day 8 | 0.86 letters |
| Sham Injection | Change in Best Corrected Visual Acuity (BCVA) From Baseline by Visit up to Day 337 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) | Change from BL at Day 225 | 1.87 letters |
Comparison: Change from baseline at Day 30p-value: 0.443180% CI: [-1.94, 2.42]Mixed Models Analysis
Comparison: Change from baseline at Day 57p-value: 0.692480% CI: [-3.72, 1.63]Mixed Models Analysis
Comparison: Change from baseline at Day 2p-value: 0.924380% CI: [-5.15, -0.29]Mixed Models Analysis
Comparison: Change from baseline at Day 2p-value: 0.392980% CI: [-1.89, 2.91]Mixed Models Analysis
Comparison: Change from baseline at Day 2p-value: 0.041880% CI: [0.85, 5.61]Mixed Models Analysis
Comparison: Change from baseline at Day 8p-value: 0.563280% CI: [-2.91, 2.27]Mixed Models Analysis
Comparison: Change from baseline at Day 8p-value: 0.257580% CI: [-1.25, 3.83]Mixed Models Analysis
Comparison: Change from baseline at Day 8p-value: 0.205880% CI: [-0.91, 4.12]Mixed Models Analysis
Comparison: Change from baseline at Day 15p-value: 0.839280% CI: [-4.44, 0.57]Mixed Models Analysis
Comparison: Change from baseline at Day 15p-value: 0.525580% CI: [-2.59, 2.35]Mixed Models Analysis
Comparison: Change from baseline at Day 15p-value: 0.168580% CI: [-0.61, 4.24]Mixed Models Analysis
Comparison: Change from baseline at Day 29p-value: 0.854480% CI: [-4.45, 0.43]Mixed Models Analysis
Comparison: Change from baseline at Day 29p-value: 0.140280% CI: [-0.38, 4.44]Mixed Models Analysis
Comparison: Change from baseline at Day 29p-value: 0.01580% CI: [1.67, 6.4]Mixed Models Analysis
Comparison: Change from baseline at Day 30p-value: 0.468280% CI: [-2.11, 2.39]Mixed Models Analysis
Comparison: Change from baseline at Day 30p-value: 0.412580% CI: [-1.84, 2.6]Mixed Models Analysis
Comparison: Change from baseline at Day 57p-value: 0.61680% CI: [-3.26, 2.04]Mixed Models Analysis
Comparison: Change from baseline at Day 57p-value: 0.414980% CI: [-2.18, 3.06]Mixed Models Analysis
Comparison: Change from baseline at Day 85p-value: 0.258280% CI: [-1.27, 3.85]Mixed Models Analysis
Comparison: Change from baseline at Day 85p-value: 0.340280% CI: [-1.72, 3.34]Mixed Models Analysis
Comparison: Change from baseline at Day 85p-value: 0.597680% CI: [-2.99, 2.03]Mixed Models Analysis
Comparison: Change from baseline at Day 113p-value: 0.591680% CI: [-3.3, 2.29]Mixed Models Analysis
Comparison: Change from baseline at Day 113p-value: 0.556480% CI: [-3.05, 2.45]Mixed Models Analysis
Comparison: Change from baseline at Day 113p-value: 0.462580% CI: [-2.53, 2.93]Mixed Models Analysis
Comparison: Change from baseline at Day 141p-value: 0.822180% CI: [-4.64, 0.76]Mixed Models Analysis
Comparison: Change from baseline at Day 141p-value: 0.317980% CI: [-1.68, 3.64]Mixed Models Analysis
Comparison: Change from baseline at Day 141p-value: 0.077380% CI: [0.29, 5.55]Mixed Models Analysis
Comparison: Change from baseline at Day 169p-value: 0.670880% CI: [-3.71, 1.81]Mixed Models Analysis
Comparison: Change from baseline at Day 169p-value: 0.67980% CI: [-3.71, 1.74]Mixed Models Analysis
Comparison: Change from baseline at Day 169p-value: 0.50780% CI: [-2.72, 2.64]Mixed Models Analysis
Comparison: Change from baseline at Day 197p-value: 0.548780% CI: [-3.44, 2.84]Mixed Models Analysis
Comparison: Change from baseline at Day 197p-value: 0.697380% CI: [-4.35, 1.85]Mixed Models Analysis
Comparison: Change from baseline at Day 197p-value: 0.654880% CI: [-4, 2.11]Mixed Models Analysis
Comparison: Change from baseline at Day 225p-value: 0.553380% CI: [-3.76, 3.05]Mixed Models Analysis
Comparison: Change from baseline at Day 225p-value: 0.335880% CI: [-2.25, 4.46]Mixed Models Analysis
Comparison: Change from baseline at Day 225p-value: 0.28580% CI: [-1.85, 4.77]Mixed Models Analysis
Comparison: Change from baseline at Day 253p-value: 0.577880% CI: [-4.14, 3.04]Mixed Models Analysis
Comparison: Change from baseline at Day 253p-value: 0.201880% CI: [-1.24, 5.85]Mixed Models Analysis
Comparison: Change from baseline at Day 253p-value: 0.145780% CI: [-0.62, 6.32]Mixed Models Analysis
Comparison: Change from baseline at Day 281p-value: 0.575880% CI: [-4.29, 3.18]Mixed Models Analysis
Comparison: Change from baseline at Day 281p-value: 0.383380% CI: [-2.84, 4.55]Mixed Models Analysis
Comparison: Change from baseline at Day 281p-value: 0.308380% CI: [-2.21, 5.02]Mixed Models Analysis
Comparison: Change from baseline at Day 309p-value: 0.706380% CI: [-5.19, 2.11]Mixed Models Analysis
Comparison: Change from baseline at Day 309p-value: 0.222780% CI: [-1.46, 5.74]Mixed Models Analysis
Comparison: Change from baseline at Day 309p-value: 0.090780% CI: [0.15, 7.21]Mixed Models Analysis
Comparison: Change from baseline at Day 337p-value: 0.479980% CI: [-4.23, 4.57]Mixed Models Analysis
Comparison: Change from baseline at Day 337p-value: 0.523780% CI: [-4.54, 4.14]Mixed Models Analysis
Comparison: Change from baseline at Day 337p-value: 0.545180% CI: [-4.62, 3.87]Mixed Models Analysis
Secondary
Change in GA Lesion Size From Baseline to Day 85, 169, and 253 as Measured by FAF
Geographic atrophy, also known as atrophic age-related macular degeneration (AMD) or advanced dry AMD, is an advanced form of age-related macular degeneration that can result in the progressive and irreversible loss of retina which can lead to a loss of visual function over time. Geographic atrophy (GA) lesion size was assessed by a Central Reading Center (CRC) using FAF. Baseline is defined as the last measurement prior to first dose of treatment. One eye (study eye) contributed to the analysis.
Time frame: Baseline (Day 1), Day 85, Day 169, Day 253
Population: PPS. At each time point, only subjects with a value at both baseline and that time point are included.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| CLG561 | Change in GA Lesion Size From Baseline to Day 85, 169, and 253 as Measured by FAF | Change from BL at Day 169 | 0.69 mm2 |
| CLG561 | Change in GA Lesion Size From Baseline to Day 85, 169, and 253 as Measured by FAF | Change from BL at Day 85 | 0.41 mm2 |
| CLG561 | Change in GA Lesion Size From Baseline to Day 85, 169, and 253 as Measured by FAF | Change from BL at Day 253 | 1.08 mm2 |
| CLG561+LFG316 | Change in GA Lesion Size From Baseline to Day 85, 169, and 253 as Measured by FAF | Change from BL at Day 169 | 0.81 mm2 |
| CLG561+LFG316 | Change in GA Lesion Size From Baseline to Day 85, 169, and 253 as Measured by FAF | Change from BL at Day 85 | 0.41 mm2 |
| CLG561+LFG316 | Change in GA Lesion Size From Baseline to Day 85, 169, and 253 as Measured by FAF | Change from BL at Day 253 | 1.33 mm2 |
| Sham Injection | Change in GA Lesion Size From Baseline to Day 85, 169, and 253 as Measured by FAF | Change from BL at Day 85 | 0.37 mm2 |
| Sham Injection | Change in GA Lesion Size From Baseline to Day 85, 169, and 253 as Measured by FAF | Change from BL at Day 253 | 1.25 mm2 |
| Sham Injection | Change in GA Lesion Size From Baseline to Day 85, 169, and 253 as Measured by FAF | Change from BL at Day 169 | 0.82 mm2 |
Comparison: Change from baseline at Day 85p-value: 0.502980% CI: [-0.11, 0.11]Mixed Models Analysis
Comparison: Change from baseline at Day 85p-value: 0.68280% CI: [-0.07, 0.14]Mixed Models Analysis
Comparison: Change from baseline at Day 85p-value: 0.682680% CI: [-0.07, 0.14]Mixed Models Analysis
Comparison: Change from baseline at Day 169p-value: 0.154580% CI: [-0.28, 0.03]Mixed Models Analysis
Comparison: Change from baseline at Day 169p-value: 0.139880% CI: [-0.29, 0.02]Mixed Models Analysis
Comparison: Change from baseline at Day 169p-value: 0.471780% CI: [-0.16, 0.14]Mixed Models Analysis
Comparison: Change from baseline at Day 253p-value: 0.05380% CI: [-0.45, -0.05]Mixed Models Analysis
Comparison: Change from baseline at Day 253p-value: 0.138680% CI: [-0.37, 0.03]Mixed Models Analysis
Comparison: Change from baseline at Day 253p-value: 0.708780% CI: [-0.11, 0.27]Mixed Models Analysis
Secondary
Change in LLVA Deficit From Baseline up to Day 337 as Measured by ETDRS
Low Luminance Visual Acuity (VA) was assessed using ETDRS testing at 4 meters with a neutral density filter to reduce chart luminance to 3 candelas/m2. A deficit in LLVA is defined as a loss in letters read from baseline. Baseline is defined as the last measurement prior to first dose of treatment. A negative change value indicates improvement (more letters read). One eye (study eye) contributed to the analysis.
Time frame: Baseline (Day 1), Day 2, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 197, Day 225, Day 253, Day 281, Day 309, Day 337
Population: FAS. At each time point, only subjects with a value at both baseline and that time point are included.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| CLG561 | Change in LLVA Deficit From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 309 | -0.62 letters |
| CLG561 | Change in LLVA Deficit From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 225 | -0.08 letters |
| CLG561 | Change in LLVA Deficit From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 141 | 0.45 letters |
| CLG561 | Change in LLVA Deficit From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 57 | 1.38 letters |
| CLG561 | Change in LLVA Deficit From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 197 | -0.37 letters |
| CLG561 | Change in LLVA Deficit From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 169 | 0.80 letters |
| CLG561 | Change in LLVA Deficit From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 2 | -0.43 letters |
| CLG561 | Change in LLVA Deficit From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 29 | 2.43 letters |
| CLG561 | Change in LLVA Deficit From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 281 | -2.13 letters |
| CLG561 | Change in LLVA Deficit From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 85 | -0.10 letters |
| CLG561 | Change in LLVA Deficit From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 337 | -1.35 letters |
| CLG561 | Change in LLVA Deficit From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 253 | -0.39 letters |
| CLG561 | Change in LLVA Deficit From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 113 | -0.33 letters |
| CLG561+LFG316 | Change in LLVA Deficit From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 169 | 0.85 letters |
| CLG561+LFG316 | Change in LLVA Deficit From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 2 | 2.32 letters |
| CLG561+LFG316 | Change in LLVA Deficit From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 29 | 1.27 letters |
| CLG561+LFG316 | Change in LLVA Deficit From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 57 | 2.54 letters |
| CLG561+LFG316 | Change in LLVA Deficit From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 85 | -0.23 letters |
| CLG561+LFG316 | Change in LLVA Deficit From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 113 | 3.59 letters |
| CLG561+LFG316 | Change in LLVA Deficit From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 141 | 4.30 letters |
| CLG561+LFG316 | Change in LLVA Deficit From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 197 | 0.72 letters |
| CLG561+LFG316 | Change in LLVA Deficit From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 225 | 3.86 letters |
| CLG561+LFG316 | Change in LLVA Deficit From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 253 | 3.24 letters |
| CLG561+LFG316 | Change in LLVA Deficit From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 281 | 1.09 letters |
| CLG561+LFG316 | Change in LLVA Deficit From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 309 | 2.02 letters |
| CLG561+LFG316 | Change in LLVA Deficit From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 337 | 2.55 letters |
| Sham Injection | Change in LLVA Deficit From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 225 | 1.39 letters |
| Sham Injection | Change in LLVA Deficit From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 85 | 3.27 letters |
| Sham Injection | Change in LLVA Deficit From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 309 | 0.07 letters |
| Sham Injection | Change in LLVA Deficit From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 253 | -0.85 letters |
| Sham Injection | Change in LLVA Deficit From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 57 | 3.07 letters |
| Sham Injection | Change in LLVA Deficit From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 2 | -0.15 letters |
| Sham Injection | Change in LLVA Deficit From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 281 | 0.14 letters |
| Sham Injection | Change in LLVA Deficit From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 169 | 0.85 letters |
| Sham Injection | Change in LLVA Deficit From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 141 | 0.83 letters |
| Sham Injection | Change in LLVA Deficit From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 29 | 0.06 letters |
| Sham Injection | Change in LLVA Deficit From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 197 | 2.08 letters |
| Sham Injection | Change in LLVA Deficit From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 113 | 1.83 letters |
| Sham Injection | Change in LLVA Deficit From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 337 | 1.37 letters |
Comparison: Change from baseline at Day 2p-value: 0.091380% CI: [-5.38, -0.11]Mixed Models Analysis
Comparison: Change from baseline at Day 2p-value: 0.445480% CI: [-2.89, 2.33]Mixed Models Analysis
Comparison: Change from baseline at Day 2p-value: 0.886180% CI: [-0.16, 5.08]Mixed Models Analysis
Comparison: Change from baseline at Day 29p-value: 0.71380% CI: [-1.49, 3.8]Mixed Models Analysis
Comparison: Change from baseline at Day 29p-value: 0.875980% CI: [-0.26, 5.01]Mixed Models Analysis
Comparison: Change from baseline at Day 29p-value: 0.725680% CI: [-1.39, 3.82]Mixed Models Analysis
Comparison: Change from baseline at Day 57p-value: 0.311180% CI: [-4.22, 1.88]Mixed Models Analysis
Comparison: Change from baseline at Day 57p-value: 0.23680% CI: [-4.73, 1.34]Mixed Models Analysis
Comparison: Change from baseline at Day 57p-value: 0.41180% CI: [-3.55, 2.49]Mixed Models Analysis
Comparison: Change from baseline at Day 85p-value: 0.524780% CI: [-2.57, 2.83]Mixed Models Analysis
Comparison: Change from baseline at Day 85p-value: 0.053480% CI: [-6.04, -0.7]Mixed Models Analysis
Comparison: Change from baseline at Day 85p-value: 0.047580% CI: [-6.18, -0.82]Mixed Models Analysis
Comparison: Change from baseline at Day 113p-value: 0.057580% CI: [-7.11, -0.74]Mixed Models Analysis
Comparison: Change from baseline at Day 113p-value: 0.187680% CI: [-5.29, 0.97]Mixed Models Analysis
Comparison: Change from baseline at Day 113p-value: 0.764480% CI: [-1.38, 4.91]Mixed Models Analysis
Comparison: Change from baseline at Day 141p-value: 0.083880% CI: [-7.42, -0.28]Mixed Models Analysis
Comparison: Change from baseline at Day 141p-value: 0.444480% CI: [-3.89, 3.13]Mixed Models Analysis
Comparison: Change from baseline at Day 141p-value: 0.897780% CI: [-0.04, 6.97]Mixed Models Analysis
Comparison: Change from baseline at Day 169p-value: 0.491780% CI: [-2.92, 2.82]Mixed Models Analysis
Comparison: Change from baseline at Day 169p-value: 0.490980% CI: [-2.89, 2.79]Mixed Models Analysis
Comparison: Change from baseline at Day 169p-value: 0.499280% CI: [-2.82, 2.81]Mixed Models Analysis
Comparison: Change from baseline at Day 197p-value: 0.328580% CI: [-4.25, 2.07]Mixed Models Analysis
Comparison: Change from baseline at Day 197p-value: 0.156880% CI: [-5.57, 0.67]Mixed Models Analysis
Comparison: Change from baseline at Day 197p-value: 0.286780% CI: [-4.46, 1.74]Mixed Models Analysis
Comparison: Change from baseline at Day 225p-value: 0.079880% CI: [-7.51, -0.35]Mixed Models Analysis
Comparison: Change from baseline at Day 225p-value: 0.296280% CI: [-5, 2.06]Mixed Models Analysis
Comparison: Change from baseline at Day 225p-value: 0.816380% CI: [-1.05, 5.98]Mixed Models Analysis
Comparison: Change from baseline at Day 253p-value: 0.070880% CI: [-6.81, -0.47]Mixed Models Analysis
Comparison: Change from baseline at Day 253p-value: 0.57580% CI: [-2.67, 3.59]Mixed Models Analysis
Comparison: Change from baseline at Day 253p-value: 0.95680% CI: [1.03, 7.17]Mixed Models Analysis
Comparison: Change from baseline at Day 281p-value: 0.128380% CI: [-6.86, 0.42]Mixed Models Analysis
Comparison: Change from baseline at Day 281p-value: 0.208580% CI: [-5.88, 1.33]Mixed Models Analysis
Comparison: Change from baseline at Day 281p-value: 0.633580% CI: [-2.61, 4.49]Mixed Models Analysis
Comparison: Change from baseline at Day 309p-value: 0.177880% CI: [-6.31, 1.03]Mixed Models Analysis
Comparison: Change from baseline at Day 309p-value: 0.402780% CI: [-4.33, 2.94]Mixed Models Analysis
Comparison: Change from baseline at Day 309p-value: 0.75780% CI: [-1.64, 5.53]Mixed Models Analysis
Comparison: Change from baseline at Day 337p-value: 0.113280% CI: [-8.03, 0.23]Mixed Models Analysis
Comparison: Change from baseline at Day 337p-value: 0.196580% CI: [-6.8, 1.37]Mixed Models Analysis
Comparison: Change from baseline at Day 337p-value: 0.647180% CI: [-2.85, 5.21]Mixed Models Analysis
Secondary
Change in Low Luminance Visual Acuity (LLVA) From Baseline up to Day 337 as Measured by ETDRS
Low Luminance Visual Acuity (VA) was assessed using ETDRS testing at 4 meters with a neutral density filter to reduce chart luminance to 3 candelas/m2. Baseline is defined as the last measurement prior to first dose of treatment. BCVA change was defined as a change in letters read from the baseline assessment. A positive change value indicates improvement. One eye (study eye) contributed to the analysis.
Time frame: Baseline (Day 1), Day 2, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 197, Day 225, Day 253, Day 281, Day 309, Day 337
Population: FAS. At each time point, only subjects with a value at both baseline and that time point are included.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| CLG561 | Change in Low Luminance Visual Acuity (LLVA) From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 309 | 1.72 letters |
| CLG561 | Change in Low Luminance Visual Acuity (LLVA) From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 225 | 2.47 letters |
| CLG561 | Change in Low Luminance Visual Acuity (LLVA) From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 141 | 2.90 letters |
| CLG561 | Change in Low Luminance Visual Acuity (LLVA) From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 57 | 2.41 letters |
| CLG561 | Change in Low Luminance Visual Acuity (LLVA) From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 197 | 2.52 letters |
| CLG561 | Change in Low Luminance Visual Acuity (LLVA) From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 169 | 1.40 letters |
| CLG561 | Change in Low Luminance Visual Acuity (LLVA) From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 2 | -0.57 letters |
| CLG561 | Change in Low Luminance Visual Acuity (LLVA) From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 29 | 0.99 letters |
| CLG561 | Change in Low Luminance Visual Acuity (LLVA) From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 281 | 3.21 letters |
| CLG561 | Change in Low Luminance Visual Acuity (LLVA) From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 85 | 3.80 letters |
| CLG561 | Change in Low Luminance Visual Acuity (LLVA) From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 337 | 1.47 letters |
| CLG561 | Change in Low Luminance Visual Acuity (LLVA) From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 253 | 3.50 letters |
| CLG561 | Change in Low Luminance Visual Acuity (LLVA) From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 113 | 3.59 letters |
| CLG561+LFG316 | Change in Low Luminance Visual Acuity (LLVA) From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 169 | 3.03 letters |
| CLG561+LFG316 | Change in Low Luminance Visual Acuity (LLVA) From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 2 | -0.72 letters |
| CLG561+LFG316 | Change in Low Luminance Visual Acuity (LLVA) From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 29 | 3.87 letters |
| CLG561+LFG316 | Change in Low Luminance Visual Acuity (LLVA) From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 57 | 1.89 letters |
| CLG561+LFG316 | Change in Low Luminance Visual Acuity (LLVA) From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 85 | 2.89 letters |
| CLG561+LFG316 | Change in Low Luminance Visual Acuity (LLVA) From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 113 | -0.09 letters |
| CLG561+LFG316 | Change in Low Luminance Visual Acuity (LLVA) From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 141 | 1.41 letters |
| CLG561+LFG316 | Change in Low Luminance Visual Acuity (LLVA) From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 197 | 2.23 letters |
| CLG561+LFG316 | Change in Low Luminance Visual Acuity (LLVA) From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 225 | 0.69 letters |
| CLG561+LFG316 | Change in Low Luminance Visual Acuity (LLVA) From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 253 | 0.68 letters |
| CLG561+LFG316 | Change in Low Luminance Visual Acuity (LLVA) From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 281 | 1.90 letters |
| CLG561+LFG316 | Change in Low Luminance Visual Acuity (LLVA) From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 309 | 1.79 letters |
| CLG561+LFG316 | Change in Low Luminance Visual Acuity (LLVA) From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 337 | -1.09 letters |
| Sham Injection | Change in Low Luminance Visual Acuity (LLVA) From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 225 | 0.75 letters |
| Sham Injection | Change in Low Luminance Visual Acuity (LLVA) From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 85 | -0.15 letters |
| Sham Injection | Change in Low Luminance Visual Acuity (LLVA) From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 309 | -0.61 letters |
| Sham Injection | Change in Low Luminance Visual Acuity (LLVA) From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 253 | 1.71 letters |
| Sham Injection | Change in Low Luminance Visual Acuity (LLVA) From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 57 | 1.18 letters |
| Sham Injection | Change in Low Luminance Visual Acuity (LLVA) From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 2 | -1.03 letters |
| Sham Injection | Change in Low Luminance Visual Acuity (LLVA) From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 281 | 0.79 letters |
| Sham Injection | Change in Low Luminance Visual Acuity (LLVA) From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 169 | 2.78 letters |
| Sham Injection | Change in Low Luminance Visual Acuity (LLVA) From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 141 | 1.57 letters |
| Sham Injection | Change in Low Luminance Visual Acuity (LLVA) From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 29 | 1.39 letters |
| Sham Injection | Change in Low Luminance Visual Acuity (LLVA) From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 197 | 1.58 letters |
| Sham Injection | Change in Low Luminance Visual Acuity (LLVA) From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 113 | 1.67 letters |
| Sham Injection | Change in Low Luminance Visual Acuity (LLVA) From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 337 | -0.73 letters |
Comparison: Change from baseline at Day 2p-value: 0.460980% CI: [-1.79, 2.09]Mixed Models Analysis
Comparison: Change from baseline at Day 2p-value: 0.377180% CI: [-1.44, 2.37]Mixed Models Analysis
Comparison: Change from baseline at Day 2p-value: 0.416180% CI: [-1.6, 2.24]Mixed Models Analysis
Comparison: Change from baseline at Day 29p-value: 0.938580% CI: [-5.26, -0.49]Mixed Models Analysis
Comparison: Change from baseline at Day 29p-value: 0.586280% CI: [-2.76, 1.96]Mixed Models Analysis
Comparison: Change from baseline at Day 29p-value: 0.087580% CI: [0.14, 4.82]Mixed Models Analysis
Comparison: Change from baseline at Day 57p-value: 0.405980% CI: [-2.32, 3.37]Mixed Models Analysis
Comparison: Change from baseline at Day 57p-value: 0.28680% CI: [-1.58, 4.05]Mixed Models Analysis
Comparison: Change from baseline at Day 57p-value: 0.372780% CI: [-2.1, 3.52]Mixed Models Analysis
Comparison: Change from baseline at Day 85p-value: 0.33680% CI: [-1.85, 3.66]Mixed Models Analysis
Comparison: Change from baseline at Day 85p-value: 0.031680% CI: [1.24, 6.66]Mixed Models Analysis
Comparison: Change from baseline at Day 85p-value: 0.076280% CI: [0.32, 5.76]Mixed Models Analysis
Comparison: Change from baseline at Day 113p-value: 0.054480% CI: [0.75, 6.61]Mixed Models Analysis
Comparison: Change from baseline at Day 113p-value: 0.195580% CI: [-0.95, 4.77]Mixed Models Analysis
Comparison: Change from baseline at Day 113p-value: 0.784480% CI: [-4.65, 1.12]Mixed Models Analysis
Comparison: Change from baseline at Day 141p-value: 0.297380% CI: [-2.11, 5.08]Mixed Models Analysis
Comparison: Change from baseline at Day 141p-value: 0.312780% CI: [-2.18, 4.84]Mixed Models Analysis
Comparison: Change from baseline at Day 141p-value: 0.522780% CI: [-3.67, 3.36]Mixed Models Analysis
Comparison: Change from baseline at Day 169p-value: 0.764380% CI: [-4.54, 1.28]Mixed Models Analysis
Comparison: Change from baseline at Day 169p-value: 0.733180% CI: [-4.25, 1.48]Mixed Models Analysis
Comparison: Change from baseline at Day 169p-value: 0.455780% CI: [-2.59, 3.09]Mixed Models Analysis
Comparison: Change from baseline at Day 197p-value: 0.454980% CI: [-2.97, 3.55]Mixed Models Analysis
Comparison: Change from baseline at Day 197p-value: 0.353580% CI: [-2.26, 4.13]Mixed Models Analysis
Comparison: Change from baseline at Day 197p-value: 0.39780% CI: [-2.54, 3.84]Mixed Models Analysis
Comparison: Change from baseline at Day 225p-value: 0.271480% CI: [-1.99, 5.55]Mixed Models Analysis
Comparison: Change from baseline at Day 225p-value: 0.274180% CI: [-1.97, 5.41]Mixed Models Analysis
Comparison: Change from baseline at Day 225p-value: 0.508480% CI: [-3.74, 3.62]Mixed Models Analysis
Comparison: Change from baseline at Day 253p-value: 0.153780% CI: [-0.73, 6.37]Mixed Models Analysis
Comparison: Change from baseline at Day 253p-value: 0.254280% CI: [-1.69, 5.27]Mixed Models Analysis
Comparison: Change from baseline at Day 253p-value: 0.650480% CI: [-4.46, 2.4]Mixed Models Analysis
Comparison: Change from baseline at Day 281p-value: 0.340580% CI: [-2.78, 5.38]Mixed Models Analysis
Comparison: Change from baseline at Day 281p-value: 0.219480% CI: [-1.59, 6.42]Mixed Models Analysis
Comparison: Change from baseline at Day 281p-value: 0.359680% CI: [-2.87, 5.09]Mixed Models Analysis
Comparison: Change from baseline at Day 309p-value: 0.508680% CI: [-4.04, 3.9]Mixed Models Analysis
Comparison: Change from baseline at Day 309p-value: 0.221180% CI: [-1.57, 6.23]Mixed Models Analysis
Comparison: Change from baseline at Day 309p-value: 0.212680% CI: [-1.47, 6.26]Mixed Models Analysis
Comparison: Change from baseline at Day 337p-value: 0.205380% CI: [-1.44, 6.55]Mixed Models Analysis
Comparison: Change from baseline at Day 337p-value: 0.235380% CI: [-1.72, 6.12]Mixed Models Analysis
Comparison: Change from baseline at Day 337p-value: 0.547180% CI: [-4.24, 3.53]Mixed Models Analysis
Secondary
Mean Change in GA Lesion Size From Baseline to Day 421 as Measured by FAF
Geographic atrophy, also known as atrophic age-related macular degeneration (AMD) or advanced dry AMD, is an advanced form of age-related macular degeneration that can result in the progressive and irreversible loss of retina which can lead to a loss of visual function over time. Geographic atrophy (GA) lesion size was assessed by a Central Reading Center (CRC) using FAF. Baseline is defined as the last measurement prior to first dose of treatment. One eye (study eye) contributed to the analysis. Day 421 measurements were only summarized descriptively and did not include any statistical modeling.
Time frame: Baseline (Day 1), Day 421
Population: PPS. At each time point, only subjects with a value at both baseline and that time point are included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CLG561 | Mean Change in GA Lesion Size From Baseline to Day 421 as Measured by FAF | Baseline (Day 1) | 9.090 mm2 | Standard Deviation 3.9628 |
| CLG561 | Mean Change in GA Lesion Size From Baseline to Day 421 as Measured by FAF | Change from Baseline at Day 421 | 2.056 mm2 | Standard Deviation 1.0618 |
| CLG561+LFG316 | Mean Change in GA Lesion Size From Baseline to Day 421 as Measured by FAF | Baseline (Day 1) | 9.070 mm2 | Standard Deviation 3.6955 |
| CLG561+LFG316 | Mean Change in GA Lesion Size From Baseline to Day 421 as Measured by FAF | Change from Baseline at Day 421 | 2.449 mm2 | Standard Deviation 1.0691 |
| Sham Injection | Mean Change in GA Lesion Size From Baseline to Day 421 as Measured by FAF | Baseline (Day 1) | 9.017 mm2 | Standard Deviation 4.2132 |
| Sham Injection | Mean Change in GA Lesion Size From Baseline to Day 421 as Measured by FAF | Change from Baseline at Day 421 | 2.395 mm2 | Standard Deviation 1.1905 |
Secondary
Percentage of Subjects With Anti-CLG561 Antibodies up to Day 421
Samples were collected and assessed for anti-CLG561 antibodies.
Time frame: Baseline (Day 1), up to Day 421
Population: IG analysis set: All subjects in the safety analysis set with evaluable immunogenicity (IG) data and with no major protocol deviations that had an impact on the assessment of immunogenicity.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CLG561 | Percentage of Subjects With Anti-CLG561 Antibodies up to Day 421 | 0 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Anti-CLG561 Antibodies up to Day 421 | 7.7 percentage of subjects |
Secondary
Percentage of Subjects With Anti-LFG316 Antibodies up to Day 421
Samples were collected and assessed for anti-LFG316 antibodies.
Time frame: Baseline (Day 1), up to Day 421
Population: IG analysis set: All subjects in the safety analysis set with evaluable immunogenicity (IG) data and with no major protocol deviations that had an impact on the assessment of immunogenicity.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CLG561 | Percentage of Subjects With Anti-LFG316 Antibodies up to Day 421 | 0 percentage of subjects |
Secondary
Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS
BCVA was assessed using ETDRS testing at 4 meters. Baseline is defined as the last measurement prior to first dose of treatment. BCVA change was defined as a change in letters read from the baseline assessment and is reported categorically. One eye (study eye) contributed to the analysis. No statistical analysis was conducted.
Time frame: Baseline (Day 1), Day 2, Day 8, Day 15, Day 29, Day 30, Day 57, Day 85, Day 113, Day 141, Day 169, Day 197, Day 225, Day 253, Day 281, Day 309, Day 337
Population: FAS. At each time point, only subjects with a value at both baseline and that time point are included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 8, ≤ -10 letters | 5.9 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 197, ≤ -10 letters | 9.1 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 57, ≥ 5 letters | 48.6 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 2, ≤ -5 letters | 20.0 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 197, ≤ -5 letters | 21.2 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 57, ≤ -5 letters | 8.6 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 309, ≥ 10 letters | 23.3 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 197, ≥ 5 letters | 45.5 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 57, ≤ -10 letters | 2.9 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 8, ≤ -15 letters | 0.0 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 197, ≥ 10 letters | 30.3 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 57, ≤ -15 letters | 0.00 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 337, ≤ -15 letters | 6.7 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 197, ≥ 15 letters | 15.2 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 85, ≥ 15 letters | 8.6 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 309, ≥ 15 letters | 20.0 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 169, ≤ -15 letters | 0.0 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 85, ≥ 10 letters | 28.6 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 15, ≥ 15 letters | 12.1 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 169, ≤ -5 letters | 21.9 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 85, ≥ 5 letters | 45.7 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 337, ≥ 5 letters | 43.3 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 169, ≥ 5 letters | 37.5 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 85, ≤ -5 letters | 8.6 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 281, ≤ -15 letters | 6.7 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 169, ≥ 10 letters | 21.9 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 85, ≤ -10 letters | 0.0 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 15, ≥ 10 letters | 18.2 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 169, ≥ 15 letters | 12.5 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 85, ≤ -15 letters | 0.0 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 2, ≤ -10 letters | 5.7 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 141, ≤ -15 letters | 2.9 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 113, ≥ 15 letters | 8.6 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 281, ≤ -10 letters | 6.7 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 141, ≤ -10 letters | 5.9 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 113, ≥ 10 letters | 22.9 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 15, ≥ 5 letters | 36.4 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 141 ≤ -5 letters | 8.8 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 113, ≥ 5 letters | 40.0 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 2, ≥ 10 letters | 8.6 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 141, ≥ 5 letters | 44.1 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 113, ≤ -5 letters | 5.7 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 281, ≤ -5 letters | 26.7 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 169, ≤ -10 letters | 3.1 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 113, ≤ -10 letters | 2.9 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 15, ≤ -5 letters | 6.1 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 141, ≥ 10 letters | 23.5 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 113, ≤ -15 letters | 0.0 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 337, ≥ 10 letters | 30.0 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 141, ≥ 15 letters | 14.7 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 281, ≥ 5 letters | 43.3 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 15, ≤ -10 letters | 0.0 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 2, ≤ -15 letters | 5.7 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 281, ≥ 10 letters | 33.3 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 15, ≤ -15 letters | 0.0 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 2, ≥ 15 letters | 2.9 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 281, ≥ 15 letters | 23.3 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 29, ≥ 15 letters | 5.9 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 337, ≥ 15 letters | 16.7 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 253, ≤ -15 letters | 3.4 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 29, ≥ 10 letters | 20.6 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 8, ≥ 15 letters | 2.9 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 253, ≤ -10 letters | 3.4 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 29, ≥ 5 letters | 41.2 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 337, ≤ -10 letters | 13.3 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 253, ≤ -5 letters | 24.1 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 29, ≤ -5 letters | 11.8 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 309, ≤ -15 letters | 3.3 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 253, ≥ 5 letters | 44.8 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 29, ≤ -10 letters | 5.9 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 8, ≥ 10 letters | 23.5 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 253, ≥ 10 letters | 34.5 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 29, ≤ -15 letters | 0.0 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 2, ≥ 5 letters | 20.0 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 253, ≥ 15 letters | 17.2 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 30, ≥ 15 letters | 12.1 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 309, ≤ -10 letters | 10.0 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 225, ≤ -15 letters | 6.3 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 30, ≥ 10 letters | 18.2 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 8, ≥ 5 letters | 29.4 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 30, ≥ 5 letters | 45.5 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 225, ≥ 10 letters | 28.1 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 225, ≤ -10 letters | 9.4 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 30, ≤ -5 letters | 6.1 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 309, ≤ -5 letters | 20.0 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 225, ≤ -5 letters | 21.9 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 30, ≤ -10 letters | 0.0 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 8, ≤ -5 letters | 8.8 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 225, ≥ 5 letters | 37.5 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 30, ≤ -15 letters | 0.0 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 337, ≤ -5 letters | 26.7 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 225, ≥ 15 letters | 21.9 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 57, ≥ 15 letters | 11.4 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 309, ≥ 5 letters | 43.3 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 197, ≤ -15 letters | 6.1 percentage of subjects |
| CLG561 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 57, ≥ 10 letters | 22.9 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 169, ≤ -15 letters | 2.7 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 225, ≥ 10 letters | 20.0 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 2, ≥ 15 letters | 2.8 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 2, ≥ 10 letters | 5.6 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 2, ≥ 5 letters | 27.8 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 2, ≤ -5 letters | 5.6 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 2, ≤ -10 letters | 2.8 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 2, ≤ -15 letters | 0.0 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 8, ≥ 15 letters | 5.6 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 8, ≥ 10 letters | 5.6 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 8, ≥ 5 letters | 27.8 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 8, ≤ -5 letters | 8.3 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 8, ≤ -10 letters | 5.6 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 8, ≤ -15 letters | 2.8 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 15, ≥ 15 letters | 5.6 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 15, ≥ 10 letters | 11.1 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 15, ≥ 5 letters | 36.1 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 15, ≤ -5 letters | 8.3 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 15, ≤ -10 letters | 0.0 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 15, ≤ -15 letters | 0.0 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 29, ≥ 15 letters | 8.1 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 29, ≥ 10 letters | 18.9 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 29, ≥ 5 letters | 37.8 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 29, ≤ -5 letters | 5.4 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 29, ≤ -10 letters | 2.7 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 29, ≤ -15 letters | 0.0 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 30, ≥ 15 letters | 5.6 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 30, ≥ 10 letters | 13.9 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 30, ≥ 5 letters | 33.3 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 30, ≤ -5 letters | 11.1 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 30, ≤ -10 letters | 2.8 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 30, ≤ -15 letters | 2.8 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 57, ≥ 15 letters | 5.4 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 57, ≥ 10 letters | 16.2 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 57, ≥ 5 letters | 45.9 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 57, ≤ -5 letters | 13.5 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 57, ≤ -10 letters | 2.7 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 57, ≤ -15 letters | 0.00 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 85, ≥ 15 letters | 5.6 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 85, ≥ 10 letters | 13.9 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 85, ≥ 5 letters | 38.9 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 85, ≤ -5 letters | 16.7 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 85, ≤ -10 letters | 5.6 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 85, ≤ -15 letters | 2.8 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 113, ≥ 15 letters | 2.9 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 113, ≥ 10 letters | 22.9 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 113, ≥ 5 letters | 40.0 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 113, ≤ -5 letters | 17.1 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 113, ≤ -10 letters | 8.6 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 113, ≤ -15 letters | 0.0 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 141, ≥ 15 letters | 5.6 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 141, ≥ 10 letters | 19.4 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 141, ≥ 5 letters | 41.7 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 141 ≤ -5 letters | 2.8 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 141, ≤ -10 letters | 0.0 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 141, ≤ -15 letters | 0.0 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 169, ≥ 15 letters | 2.7 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 169, ≥ 10 letters | 13.5 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 169, ≥ 5 letters | 35.1 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 169, ≤ -5 letters | 18.9 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 169, ≤ -10 letters | 5.4 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 197, ≥ 15 letters | 2.8 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 197, ≥ 10 letters | 13.9 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 197, ≥ 5 letters | 41.7 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 197, ≤ -5 letters | 19.4 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 197, ≤ -10 letters | 11.1 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 197, ≤ -15 letters | 2.8 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 225, ≥ 15 letters | 8.6 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 225, ≥ 5 letters | 45.7 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 225, ≤ -5 letters | 20.0 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 225, ≤ -10 letters | 5.7 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 225, ≤ -15 letters | 5.7 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 253, ≥ 15 letters | 5.6 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 253, ≥ 10 letters | 30.6 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 253, ≥ 5 letters | 38.9 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 253, ≤ -5 letters | 19.4 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 253, ≤ -10 letters | 13.9 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 253, ≤ -15 letters | 8.3 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 281, ≥ 15 letters | 8.3 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 281, ≥ 10 letters | 22.2 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 281, ≥ 5 letters | 44.4 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 281, ≤ -5 letters | 25.0 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 281, ≤ -10 letters | 22.2 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 281, ≤ -15 letters | 11.1 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 309, ≥ 15 letters | 8.6 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 309, ≥ 10 letters | 22.9 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 309, ≥ 5 letters | 40.7 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 309, ≤ -5 letters | 22.9 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 309, ≤ -10 letters | 8.6 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 309, ≤ -15 letters | 5.7 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 337, ≥ 15 letters | 8.6 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 337, ≥ 10 letters | 20.0 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 337, ≥ 5 letters | 40.0 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 337, ≤ -5 letters | 22.9 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 337, ≤ -10 letters | 14.3 percentage of subjects |
| CLG561+LFG316 | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 337, ≤ -15 letters | 11.4 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 337, ≤ -10 letters | 14.3 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 197, ≤ -5 letters | 16.2 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 57, ≥ 10 letters | 16.2 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 309, ≥ 10 letters | 11.4 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 197, ≤ -10 letters | 10.8 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 57, ≥ 15 letters | 10.8 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 8, ≤ -5 letters | 13.2 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 197, ≤ -15 letters | 5.4 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 30, ≤ -15 letters | 2.7 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 337, ≥ 5 letters | 25.7 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 225, ≥ 15 letters | 8.1 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 225, ≥ 10 letters | 10.8 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 30, ≤ -10 letters | 5.4 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 309, ≥ 5 letters | 25.7 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 225, ≥ 5 letters | 21.6 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 30, ≤ -5 letters | 13.5 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 8, ≥ 5 letters | 21.1 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 225, ≤ -5 letters | 24.3 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 30, ≥ 5 letters | 24.3 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 2, ≥ 5 letters | 10.8 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 225, ≤ -10 letters | 16.2 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 30, ≥ 15 letters | 8.1 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 309, ≤ -5 letters | 31.4 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 225, ≤ -15 letters | 2.7 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 29, ≤ -15 letters | 2.6 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 8, ≥ 10 letters | 5.3 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 253, ≥ 15 letters | 13.9 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 29, ≤ -10 letters | 5.3 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 2, ≥ 15 letters | 0.0 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 253, ≥ 10 letters | 16.7 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 29, ≤ -5 letters | 13.2 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 309, ≤ -10 letters | 22.9 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 253, ≥ 5 letters | 16.7 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 29, ≥ 5 letters | 18.4 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 8, ≥ 15 letters | 0.0 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 253, ≤ -5 letters | 27.8 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 29, ≥ 10 letters | 10.5 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 337, ≤ -5 letters | 34.3 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 253, ≤ -10 letters | 19.4 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 29, ≥ 15 letters | 2.6 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 309, ≤ -15 letters | 8.6 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 253, ≤ -15 letters | 11.1 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 15, ≤ -15 letters | 0.0 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 2, ≤ -15 letters | 5.4 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 281, ≥ 15 letters | 8.6 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 15, ≤ -10 letters | 0.0 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 2, ≥ 10 letters | 2.7 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 281, ≥ 10 letters | 14.3 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 15, ≤ -5 letters | 15.8 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 337, ≥ 15 letters | 5.7 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 113, ≤ -15 letters | 2.6 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 281, ≥ 5 letters | 28.6 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 141, ≥ 15 letters | 10.5 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 113, ≤ -10 letters | 5.3 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 113, ≤ -5 letters | 13.2 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 15, ≥ 5 letters | 26.3 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 141, ≥ 10 letters | 15.8 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 113, ≥ 5 letters | 23.7 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 2, ≤ -10 letters | 5.4 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 141, ≥ 5 letters | 23.7 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 113, ≥ 10 letters | 13.2 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 281, ≤ -5 letters | 25.7 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 141 ≤ -5 letters | 26.3 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 113, ≥ 15 letters | 7.9 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 15, ≥ 10 letters | 15.8 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 141, ≤ -10 letters | 7.9 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 85, ≤ -15 letters | 0.0 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 337, ≤ -15 letters | 5.7 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 141, ≤ -15 letters | 0.0 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 85, ≤ -10 letters | 2.7 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 281, ≤ -10 letters | 20.0 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 169, ≥ 15 letters | 13.5 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 85, ≤ -5 letters | 13.5 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 15, ≥ 15 letters | 7.9 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 169, ≥ 10 letters | 18.9 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 85, ≥ 5 letters | 24.3 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 337, ≥ 10 letters | 11.4 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 169, ≥ 5 letters | 24.3 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 85, ≥ 10 letters | 13.5 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 281, ≤ -15 letters | 11.4 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 169, ≤ -5 letters | 10.8 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 8, ≤ -15 letters | 0.0 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 169, ≤ -10 letters | 2.7 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 85, ≥ 15 letters | 8.1 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 30, ≥ 10 letters | 13.5 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 169, ≤ -15 letters | 0.0 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 57, ≤ -15 letters | 0.00 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 2, ≤ -5 letters | 18.9 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 197, ≥ 15 letters | 10.8 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 57, ≤ -10 letters | 2.7 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 309, ≥ 15 letters | 2.9 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 197, ≥ 10 letters | 18.9 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 57, ≤ -5 letters | 13.5 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 8, ≤ -10 letters | 5.3 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 197, ≥ 5 letters | 32.4 percentage of subjects |
| Sham Injection | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | Change from BL at Day 57, ≥ 5 letters | 35.1 percentage of subjects |
Secondary
Total CLG561 Serum Concentrations up to Day 421
Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method.
Time frame: Baseline (Day 1), Day 2, Day 8, Day 15, Day 29, Day 85, Day 169, Day 253, Day 309, Day 337, Day 421
Population: PK Analysis Set. At each time point, only subjects with a value at both baseline and that time point are included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CLG561 | Total CLG561 Serum Concentrations up to Day 421 | Day 15 | 476 ng/mL | Standard Deviation 76 |
| CLG561 | Total CLG561 Serum Concentrations up to Day 421 | Day 169 | 294 ng/mL | Standard Deviation 225 |
| CLG561 | Total CLG561 Serum Concentrations up to Day 421 | Day 8 | 821 ng/mL | Standard Deviation 483 |
| CLG561 | Total CLG561 Serum Concentrations up to Day 421 | Day 253 | 97 ng/mL | Standard Deviation 178 |
| CLG561 | Total CLG561 Serum Concentrations up to Day 421 | Day 29 | 181 ng/mL | Standard Deviation 255 |
| CLG561 | Total CLG561 Serum Concentrations up to Day 421 | Day 309 | 161 ng/mL | Standard Deviation 236 |
| CLG561 | Total CLG561 Serum Concentrations up to Day 421 | Day 2 | 998 ng/mL | Standard Deviation 471 |
| CLG561 | Total CLG561 Serum Concentrations up to Day 421 | Day 337 | 281 ng/mL | Standard Deviation 242 |
| CLG561 | Total CLG561 Serum Concentrations up to Day 421 | Day 85 | 271 ng/mL | Standard Deviation 236 |
| CLG561 | Total CLG561 Serum Concentrations up to Day 421 | Day 421 | 0 ng/mL | Standard Deviation 0 |
| CLG561 | Total CLG561 Serum Concentrations up to Day 421 | Baseline | 0 ng/mL | Standard Deviation 0 |
| CLG561+LFG316 | Total CLG561 Serum Concentrations up to Day 421 | Day 421 | 0 ng/mL | Standard Deviation 0 |
| CLG561+LFG316 | Total CLG561 Serum Concentrations up to Day 421 | Baseline | 0 ng/mL | Standard Deviation 0 |
| CLG561+LFG316 | Total CLG561 Serum Concentrations up to Day 421 | Day 2 | 475 ng/mL | Standard Deviation 57 |
| CLG561+LFG316 | Total CLG561 Serum Concentrations up to Day 421 | Day 8 | 417 ng/mL | Standard Deviation 90 |
| CLG561+LFG316 | Total CLG561 Serum Concentrations up to Day 421 | Day 15 | 428 ng/mL | — |
| CLG561+LFG316 | Total CLG561 Serum Concentrations up to Day 421 | Day 29 | 0 ng/mL | — |
| CLG561+LFG316 | Total CLG561 Serum Concentrations up to Day 421 | Day 85 | 0 ng/mL | Standard Deviation 0 |
| CLG561+LFG316 | Total CLG561 Serum Concentrations up to Day 421 | Day 169 | 75 ng/mL | Standard Deviation 160 |
| CLG561+LFG316 | Total CLG561 Serum Concentrations up to Day 421 | Day 253 | 36 ng/mL | Standard Deviation 112 |
| CLG561+LFG316 | Total CLG561 Serum Concentrations up to Day 421 | Day 309 | 31 ng/mL | Standard Deviation 113 |
| CLG561+LFG316 | Total CLG561 Serum Concentrations up to Day 421 | Day 337 | 54 ng/mL | Standard Deviation 139 |
Secondary
Total LFG316 Serum Concentration up to Day 421
Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method.
Time frame: Baseline (Day 1), Day 337, Day 421
Population: PK Analysis Set. At each time point, only subjects with a value at both baseline and that time point are included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CLG561 | Total LFG316 Serum Concentration up to Day 421 | Baseline | 0 ng/mL | — |
| CLG561 | Total LFG316 Serum Concentration up to Day 421 | Day 337 | 338 ng/mL | — |
| CLG561 | Total LFG316 Serum Concentration up to Day 421 | Day 421 | 0 ng/mL | Standard Deviation 0 |