Geographic Atrophy, Macular Degeneration, Visual Acuity
Conditions
Keywords
Best Corrected Visual Acuity, Geographic Atrophy, Macular Degeneration, CNTO 2476
Brief summary
The purpose of this study is to evaluate the safety and performance profile of the suprachoroidal surgical approach and the Delivery System.
Detailed description
This is a multicenter (when more than one hospital or medical school team work on a medical research study) study which includes an initial unmasked safety phase. The duration of participation in the study for each participant is approximately 3 years. Efficacy will be evaluated at 6 months, 12 months and annually thereafter. Participants' safety will be monitored throughout the study.
Interventions
DRUGCNTO 2476 3.0 x 10^5 cells
Participants will receive a single subretinal administration of CNTO 2476 3.0 x 10\^5 cells in 50 microliter (mcL) given by subretinal Delivery System.
DEVICESubretinal Delivery System
Participants will receive CNTO 2476 by using the Delivery System.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) confirmed within 45 days prior to initial randomization verified by the central reading center * Study eyes will have a best corrected visual acuity (BCVA) of 20/80 to 20/800 \[Early Treatment Diabetic Retinopathy Study (ETDRS) log of the minimum angle of resolution (logMAR) value 0.6-1.6\]. The treatment eye will be that with the worse BCVA at Screening. If BCVA is clinically equivalent, the eye with the larger GA determines the study eye * Participant is a suitable candidate for ophthalmologic surgery, is willing and able to comply with the surgical procedure, scheduled visits, treatment plan, laboratory tests and other study procedures. Participant has met criteria of the surgery center anti-coagulation protocol, if applicable * Each participant must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study
Exclusion criteria
* Participant has a history of neovascular (wet) AMD in the treatment eye, including evidence of retinal pigment epithelium rips or evidence of subretinal or choroidal neovascularization or fluid. In cases where imaging is inconclusive, review of the case with the study site, considering history and imaging will determine eligibility. History or evidence of neovascular AMD in the fellow eye is allowed, if anti-vascular endothelial growth factor (VEGF) therapy has not been required for at least 8 weeks prior to Screening * Geographic atrophy secondary to any causes other than AMD in either eye * A diagnosis of glaucoma with an intraocular pressure (IOP) greater than or equal to (\>=) 25 millimeter of mercury (mmHg) while being treated with an ocular hypotensive drug. Treatment should be no more than 1 drug preparation/combination, which can contain 1 or 2 ocular hypotensive active ingredients; participants receiving more than 2 ocular hypotensive active ingredients are excluded * Nuclear sclerotic cataract, cortical spoking, posterior subcapsular cataract above Grade 2 per Age Related Eye Disease Study (AREDS) scale or any other ophthalmologic condition that reduces the clarity of the media that, in the opinion of the investigator or reading center, interferes with ophthalmologic examination (example, corneal abnormalities, inadequate pupillary dilation), surgery or imaging in the study eye * Myopia greater than minus (\>-) 8 diopters and participants with greater than (\>) 4 diopters of astigmatism, and greater than plus (\>+) 10 diopters of hyperopia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 36- Fellow Eye | Baseline and Month 36 | BCVA was assessed in the fellow eye. BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement. |
| Change From Baseline in Best Corrected Visual Acuity (BCVA) Total Letters Score at Month 1- Fellow Eye | Baseline and Month 1 | BCVA was assessed in the fellow eye. BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement. |
| Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 2- Fellow Eye | Baseline and Month 2 | BCVA was assessed in the fellow eye. BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement. |
| Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 3- Fellow Eye | Baseline and Month 3 | BCVA was assessed in the fellow eye. BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement. |
| Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 6- Fellow Eye | Baseline and Month 6 | BCVA was assessed in the fellow eye. BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement. |
| Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 12- Fellow Eye | Baseline and Month 12 | BCVA was assessed in the fellow eye. BCVA measurements were made using logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there are 5 letters per line, the total score for a line on the logMAR chart represents a change of 0.1 log units. The formula for calculating the logMAR BCVA score is: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement. |
| Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 18- Fellow Eye | Baseline and Month 18 | BCVA was assessed in the fellow eye. BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement. |
| Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 24- Fellow Eye | Baseline and Month 24 | BCVA was assessed in the fellow eye. BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement. |
| Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 30- Fellow Eye | Baseline and Month 30 | BCVA was assessed in the fellow eye. BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement. |
| Change From Baseline in Best Corrected Visual Acuity (BCVA) Total Letters Score at Month 1- Treated Eye | Baseline and Month 1 | Best corrected visual acuity (BCVA) was assessed in the study eye (Treated eye). BCVA measurements were made using the logarithm of the minimum angle of resolution (logMAR) visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement. |
| Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 2- Treated Eye | Baseline and Month 2 | BCVA was assessed in the study eye (Treated eye). BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement. |
| Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 3- Treated Eye | Baseline and Month 3 | BCVA was assessed in the study eye (Treated eye). BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement. |
| Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 6- Treated Eye | Baseline and Month 6 | BCVA was assessed in the study eye (Treated eye). BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement. |
| Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 12- Treated Eye | Baseline and Month 12 | BCVA was assessed in the study eye (Treated eye). BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement. |
| Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 18- Treated Eye | Baseline and Month 18 | BCVA was assessed in the study eye (Treated eye). BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement. |
| Change From Baseline in Best Corrected Visual Acuity (BCVA) Total Letters Score at Month 24- Treated Eye | Baseline and Month 24 | BCVA was assessed in the study eye (Treated eye). BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement. |
| Change From Baseline in Best Corrected Visual Acuity (BCVA) Total Letters Score at Month 30- Treated Eye | Baseline and Month 30 | BCVA was assessed in the study eye (Treated eye). BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement. |
| Change From Baseline in Best Corrected Visual Acuity (BCVA) Total Letters Score at Month 36- Treated Eye | Baseline and Month 36 | BCVA was assessed in the study eye (Treated eye). BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Losing >=15 Best Corrected Visual Acuity Letters: Fellow Eye | Months 1, 2 , 3, 6, 12, 18, 24, 30 and 36 | BCVA was assessed as letters read using early treatment diabetic retinopathy study charts and reported as the number of letters read correctly (ranging from 0 to 100 letters) in the fellow eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. The percentage of participants losing \>=15 BCVA in the fellow eye were reported. |
| Change From Baseline in Best Corrected Visual Acuity Letters at Months 6 and 12: Treated Eye | Baseline, Months 6 and 12 | BCVA was assessed as letters read using early treatment diabetic retinopathy study charts and reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye (Treated eye). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. |
| Change From Baseline in Best Corrected Visual Acuity at Months 6 and 12: Fellow Eye | Baseline, Months 6 and 12 | BCVA was assessed as letters read using early treatment diabetic retinopathy study charts and reported as the number of letters read correctly (ranging from 0 to 100 letters) in the fellow eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. |
| Change From Baseline in Growth Rate of Geographic Atrophy (GA) Lesion Area at Months 6 and 12: Treated Eye | Baseline, Months 6 and 12 | The area of GA was determined based primarily on fundus autofluorescence (FAF). The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of GA lesion area (worsening; disease progression). |
| Change From Baseline in Growth Rate of Geographic Atrophy Lesion Area at Months 6 and 12: Fellow Eye | Baseline, Months 6 and 12 | The area of GA was determined based primarily on FAF. The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of GA lesion area (worsening; disease progression). |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Up to Months 36 | Number of participants with TEAEs and SAEs were assessed. An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment and can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product. SAE is defined as any untoward medical occurrence that at any dose results in death, Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Is a congenital anomaly/birth defect, Is a suspected transmission of any infectious agent via a medicinal product. |
| Number of Participants With Ocular Treatment-emergent Adverse Events | Up to Months 36 | Number of participants with ocular TEAE were assessed. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment and can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product. |
| Percentage of Participants Losing Greater Than or Equal to (>=) 15 Best Corrected Visual Acuity Letters: Treated Eye | Months 1, 2 , 3, 6, 12, 18, 24, 30 and 36 | BCVA was assessed as letters read using early treatment diabetic retinopathy study charts and reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye (Treated eye). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. The percentage of participants losing \>=15 BCVA in the study eye were reported. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CNTO 2476 3.0*10^5 Cells Participants received a single subretinal administration of CNTO 2476 (Palucorcel) comprising 3.0\*10\^5 cells in 50 microliters (mcL) dosing volume on Day 1. CNTO 2476 was delivered using the custom-designed Delivery System and surgical procedure. | 21 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 7 |
Baseline characteristics
| Characteristic | CNTO 2476 3.0*10^5 Cells |
|---|---|
| Age, Continuous | 76.9 years STANDARD_DEVIATION 10.12 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 21 Participants |
| Region of Enrollment UNITED STATES | 21 Participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 21 |
| other Total, other adverse events | 18 / 21 |
| serious Total, serious adverse events | 5 / 21 |
Outcome results
Primary
Change From Baseline in Best Corrected Visual Acuity (BCVA) Total Letters Score at Month 1- Fellow Eye
BCVA was assessed in the fellow eye. BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Time frame: Baseline and Month 1
Population: The safety analysis set defined as participants who were enrolled and received surgery in the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CNTO 2476 3.0*10^5 Cells | Change From Baseline in Best Corrected Visual Acuity (BCVA) Total Letters Score at Month 1- Fellow Eye | 0.017 logMAR | Standard Deviation 0.0962 |
Primary
Change From Baseline in Best Corrected Visual Acuity (BCVA) Total Letters Score at Month 1- Treated Eye
Best corrected visual acuity (BCVA) was assessed in the study eye (Treated eye). BCVA measurements were made using the logarithm of the minimum angle of resolution (logMAR) visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Time frame: Baseline and Month 1
Population: The safety analysis set defined as participants who were enrolled and received surgery in the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CNTO 2476 3.0*10^5 Cells | Change From Baseline in Best Corrected Visual Acuity (BCVA) Total Letters Score at Month 1- Treated Eye | 0.132 logMAR | Standard Deviation 0.2093 |
Primary
Change From Baseline in Best Corrected Visual Acuity (BCVA) Total Letters Score at Month 24- Treated Eye
BCVA was assessed in the study eye (Treated eye). BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Time frame: Baseline and Month 24
Population: The safety analysis set defined as participants who were enrolled and received surgery in the study. Here, N (number of participants analyzed) signifies number of participant evaluable for this endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CNTO 2476 3.0*10^5 Cells | Change From Baseline in Best Corrected Visual Acuity (BCVA) Total Letters Score at Month 24- Treated Eye | 0.145 logMAR | Standard Deviation 0.3065 |
Primary
Change From Baseline in Best Corrected Visual Acuity (BCVA) Total Letters Score at Month 30- Treated Eye
BCVA was assessed in the study eye (Treated eye). BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Time frame: Baseline and Month 30
Population: The safety analysis set defined as participants who were enrolled and received surgery in the study. Here, N (number of participants analyzed) signifies number of participant evaluable for this endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CNTO 2476 3.0*10^5 Cells | Change From Baseline in Best Corrected Visual Acuity (BCVA) Total Letters Score at Month 30- Treated Eye | 0.112 logMAR | Standard Deviation 0.3093 |
Primary
Change From Baseline in Best Corrected Visual Acuity (BCVA) Total Letters Score at Month 36- Treated Eye
BCVA was assessed in the study eye (Treated eye). BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Time frame: Baseline and Month 36
Population: The safety analysis set defined as participants who were enrolled and received surgery in the study. Here, N (number of participants analyzed) signifies number of participant evaluable for this endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CNTO 2476 3.0*10^5 Cells | Change From Baseline in Best Corrected Visual Acuity (BCVA) Total Letters Score at Month 36- Treated Eye | 0.211 logMAR | Standard Deviation 0.3639 |
Primary
Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 12- Fellow Eye
BCVA was assessed in the fellow eye. BCVA measurements were made using logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there are 5 letters per line, the total score for a line on the logMAR chart represents a change of 0.1 log units. The formula for calculating the logMAR BCVA score is: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Time frame: Baseline and Month 12
Population: The safety analysis set defined as participants who were enrolled and received surgery in the study. Here, N (number of participants analyzed) signifies number of participant evaluable for this endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CNTO 2476 3.0*10^5 Cells | Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 12- Fellow Eye | 0.074 logMAR | Standard Deviation 0.1807 |
Primary
Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 12- Treated Eye
BCVA was assessed in the study eye (Treated eye). BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Time frame: Baseline and Month 12
Population: The safety analysis set defined as participants who were enrolled and received surgery in the study. Here, N (number of participants analyzed) signifies number of participant evaluable for this endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CNTO 2476 3.0*10^5 Cells | Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 12- Treated Eye | 0.119 logMAR | Standard Deviation 0.2598 |
Primary
Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 18- Fellow Eye
BCVA was assessed in the fellow eye. BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Time frame: Baseline and Month 18
Population: The safety analysis set defined as participants who were enrolled and received surgery in the study. Here, N (number of participants analyzed) signifies number of participant evaluable for this endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CNTO 2476 3.0*10^5 Cells | Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 18- Fellow Eye | 0.075 logMAR | Standard Deviation 0.1728 |
Primary
Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 18- Treated Eye
BCVA was assessed in the study eye (Treated eye). BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Time frame: Baseline and Month 18
Population: The safety analysis set defined as participants who were enrolled and received surgery in the study. Here, N (number of participants analyzed) signifies number of participant evaluable for this endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CNTO 2476 3.0*10^5 Cells | Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 18- Treated Eye | 0.107 logMAR | Standard Deviation 0.2512 |
Primary
Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 24- Fellow Eye
BCVA was assessed in the fellow eye. BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Time frame: Baseline and Month 24
Population: The safety analysis set defined as participants who were enrolled and received surgery in the study. Here, N (number of participants analyzed) signifies number of participant evaluable for this endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CNTO 2476 3.0*10^5 Cells | Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 24- Fellow Eye | 0.115 logMAR | Standard Deviation 0.1962 |
Primary
Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 2- Fellow Eye
BCVA was assessed in the fellow eye. BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Time frame: Baseline and Month 2
Population: The safety analysis set defined as participants who were enrolled and received surgery in the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CNTO 2476 3.0*10^5 Cells | Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 2- Fellow Eye | 0.027 logMAR | Standard Deviation 0.0868 |
Primary
Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 2- Treated Eye
BCVA was assessed in the study eye (Treated eye). BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Time frame: Baseline and Month 2
Population: The safety analysis set defined as participants who were enrolled and received surgery in the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CNTO 2476 3.0*10^5 Cells | Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 2- Treated Eye | 0.073 logMAR | Standard Deviation 0.2273 |
Primary
Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 30- Fellow Eye
BCVA was assessed in the fellow eye. BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Time frame: Baseline and Month 30
Population: The safety analysis set defined as participants who were enrolled and received surgery in the study. Here, N (number of participants analyzed) signifies number of participant evaluable for this endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CNTO 2476 3.0*10^5 Cells | Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 30- Fellow Eye | 0.106 logMAR | Standard Deviation 0.1721 |
Primary
Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 36- Fellow Eye
BCVA was assessed in the fellow eye. BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Time frame: Baseline and Month 36
Population: The safety analysis set defined as participants who were enrolled and received surgery in the study. Here, N (number of participants analyzed) signifies number of participant evaluable for this endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CNTO 2476 3.0*10^5 Cells | Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 36- Fellow Eye | 0.309 logMAR | Standard Deviation 0.2435 |
Primary
Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 3- Fellow Eye
BCVA was assessed in the fellow eye. BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Time frame: Baseline and Month 3
Population: The safety analysis set defined as participants who were enrolled and received surgery in the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CNTO 2476 3.0*10^5 Cells | Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 3- Fellow Eye | 0.010 logMAR | Standard Deviation 0.096 |
Primary
Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 3- Treated Eye
BCVA was assessed in the study eye (Treated eye). BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Time frame: Baseline and Month 3
Population: The safety analysis set defined as participants who were enrolled and received surgery in the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CNTO 2476 3.0*10^5 Cells | Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 3- Treated Eye | 0.079 logMAR | Standard Deviation 0.2502 |
Primary
Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 6- Fellow Eye
BCVA was assessed in the fellow eye. BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Time frame: Baseline and Month 6
Population: The safety analysis set defined as participants who were enrolled and received surgery in the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CNTO 2476 3.0*10^5 Cells | Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 6- Fellow Eye | 0.033 logMAR | Standard Deviation 0.1351 |
Primary
Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 6- Treated Eye
BCVA was assessed in the study eye (Treated eye). BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Time frame: Baseline and Month 6
Population: The safety analysis set defined as participants who were enrolled and received surgery in the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CNTO 2476 3.0*10^5 Cells | Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 6- Treated Eye | 0.090 logMAR | Standard Deviation 0.2628 |
Secondary
Change From Baseline in Best Corrected Visual Acuity at Months 6 and 12: Fellow Eye
BCVA was assessed as letters read using early treatment diabetic retinopathy study charts and reported as the number of letters read correctly (ranging from 0 to 100 letters) in the fellow eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening.
Time frame: Baseline, Months 6 and 12
Population: The safety analysis set defined as participants who were enrolled and received surgery in the study. Here 'n' (number analyzed) signifies the number of participants analyzed at the specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CNTO 2476 3.0*10^5 Cells | Change From Baseline in Best Corrected Visual Acuity at Months 6 and 12: Fellow Eye | Month 6 | -1.7 Letters | Standard Deviation 6.76 |
| CNTO 2476 3.0*10^5 Cells | Change From Baseline in Best Corrected Visual Acuity at Months 6 and 12: Fellow Eye | Month 12 | 6.76 Letters | Standard Deviation 9.03 |
Secondary
Change From Baseline in Best Corrected Visual Acuity Letters at Months 6 and 12: Treated Eye
BCVA was assessed as letters read using early treatment diabetic retinopathy study charts and reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye (Treated eye). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening.
Time frame: Baseline, Months 6 and 12
Population: The safety analysis set defined as participants who were enrolled and received surgery in the study. Here 'n' (number analyzed) signifies the number of participants analyzed at the specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CNTO 2476 3.0*10^5 Cells | Change From Baseline in Best Corrected Visual Acuity Letters at Months 6 and 12: Treated Eye | Month 6 | -4.5 Letters | Standard Deviation 13.14 |
| CNTO 2476 3.0*10^5 Cells | Change From Baseline in Best Corrected Visual Acuity Letters at Months 6 and 12: Treated Eye | Month 12 | -5.9 Letters | Standard Deviation 12.99 |
Secondary
Change From Baseline in Growth Rate of Geographic Atrophy (GA) Lesion Area at Months 6 and 12: Treated Eye
The area of GA was determined based primarily on fundus autofluorescence (FAF). The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of GA lesion area (worsening; disease progression).
Time frame: Baseline, Months 6 and 12
Population: The safety analysis set defined as participants who were enrolled and received surgery in the study. Here, N (number of participants analyzed) signifies number of participant evaluable for this endpoint and 'n' (number analyzed) signifies the number of participants analyzed at the specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CNTO 2476 3.0*10^5 Cells | Change From Baseline in Growth Rate of Geographic Atrophy (GA) Lesion Area at Months 6 and 12: Treated Eye | Month 6 | 0.6691 Square millimeter | Standard Deviation 2.3301 |
| CNTO 2476 3.0*10^5 Cells | Change From Baseline in Growth Rate of Geographic Atrophy (GA) Lesion Area at Months 6 and 12: Treated Eye | Month 12 | 2.4214 Square millimeter | Standard Deviation 1.3661 |
Secondary
Change From Baseline in Growth Rate of Geographic Atrophy Lesion Area at Months 6 and 12: Fellow Eye
The area of GA was determined based primarily on FAF. The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of GA lesion area (worsening; disease progression).
Time frame: Baseline, Months 6 and 12
Population: The safety analysis set defined as participants who were enrolled and received surgery in the study. Here, N (number of participants analyzed) signifies number of participant evaluable for this endpoint and 'n' (number analyzed) signifies the number of participants analyzed at the specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CNTO 2476 3.0*10^5 Cells | Change From Baseline in Growth Rate of Geographic Atrophy Lesion Area at Months 6 and 12: Fellow Eye | Month 6 | 1.2085 Square millimeter | Standard Deviation 0.706 |
| CNTO 2476 3.0*10^5 Cells | Change From Baseline in Growth Rate of Geographic Atrophy Lesion Area at Months 6 and 12: Fellow Eye | Month 12 | 2.6457 Square millimeter | Standard Deviation 1.9449 |
Secondary
Number of Participants With Ocular Treatment-emergent Adverse Events
Number of participants with ocular TEAE were assessed. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment and can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product.
Time frame: Up to Months 36
Population: The safety analysis set defined as participants who were enrolled and received surgery in the study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CNTO 2476 3.0*10^5 Cells | Number of Participants With Ocular Treatment-emergent Adverse Events | Treated Eye | 17 Participants |
| CNTO 2476 3.0*10^5 Cells | Number of Participants With Ocular Treatment-emergent Adverse Events | Fellow Eye | 10 Participants |
Secondary
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Number of participants with TEAEs and SAEs were assessed. An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment and can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product. SAE is defined as any untoward medical occurrence that at any dose results in death, Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Is a congenital anomaly/birth defect, Is a suspected transmission of any infectious agent via a medicinal product.
Time frame: Up to Months 36
Population: The safety analysis set defined as participants who were enrolled and received surgery in the study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CNTO 2476 3.0*10^5 Cells | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Treatment-emergent Adverse Events | 20 Participants |
| CNTO 2476 3.0*10^5 Cells | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Treatment-emergent Serious Adverse Events | 5 Participants |
Secondary
Percentage of Participants Losing >=15 Best Corrected Visual Acuity Letters: Fellow Eye
BCVA was assessed as letters read using early treatment diabetic retinopathy study charts and reported as the number of letters read correctly (ranging from 0 to 100 letters) in the fellow eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. The percentage of participants losing \>=15 BCVA in the fellow eye were reported.
Time frame: Months 1, 2 , 3, 6, 12, 18, 24, 30 and 36
Population: The safety analysis set defined as participants who were enrolled and received surgery in the study. Here 'n' (number analyzed) signifies the number of participants who had BCVA data at a visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CNTO 2476 3.0*10^5 Cells | Percentage of Participants Losing >=15 Best Corrected Visual Acuity Letters: Fellow Eye | Month 1: Week 4 | 0 Percentage of Participants |
| CNTO 2476 3.0*10^5 Cells | Percentage of Participants Losing >=15 Best Corrected Visual Acuity Letters: Fellow Eye | Month 2 | 0 Percentage of Participants |
| CNTO 2476 3.0*10^5 Cells | Percentage of Participants Losing >=15 Best Corrected Visual Acuity Letters: Fellow Eye | Month 3 | 0 Percentage of Participants |
| CNTO 2476 3.0*10^5 Cells | Percentage of Participants Losing >=15 Best Corrected Visual Acuity Letters: Fellow Eye | Month 6 | 4.8 Percentage of Participants |
| CNTO 2476 3.0*10^5 Cells | Percentage of Participants Losing >=15 Best Corrected Visual Acuity Letters: Fellow Eye | Month 12 | 16.7 Percentage of Participants |
| CNTO 2476 3.0*10^5 Cells | Percentage of Participants Losing >=15 Best Corrected Visual Acuity Letters: Fellow Eye | Month 18 | 17.6 Percentage of Participants |
| CNTO 2476 3.0*10^5 Cells | Percentage of Participants Losing >=15 Best Corrected Visual Acuity Letters: Fellow Eye | Month 24 | 13.3 Percentage of Participants |
| CNTO 2476 3.0*10^5 Cells | Percentage of Participants Losing >=15 Best Corrected Visual Acuity Letters: Fellow Eye | Month 30 | 14.3 Percentage of Participants |
| CNTO 2476 3.0*10^5 Cells | Percentage of Participants Losing >=15 Best Corrected Visual Acuity Letters: Fellow Eye | Month 36 | 46.2 Percentage of Participants |
Secondary
Percentage of Participants Losing Greater Than or Equal to (>=) 15 Best Corrected Visual Acuity Letters: Treated Eye
BCVA was assessed as letters read using early treatment diabetic retinopathy study charts and reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye (Treated eye). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. The percentage of participants losing \>=15 BCVA in the study eye were reported.
Time frame: Months 1, 2 , 3, 6, 12, 18, 24, 30 and 36
Population: The safety analysis set defined as participants who were enrolled and received surgery in the study. Here 'n' (number analyzed) signifies the number of participants who had BCVA data at a visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CNTO 2476 3.0*10^5 Cells | Percentage of Participants Losing Greater Than or Equal to (>=) 15 Best Corrected Visual Acuity Letters: Treated Eye | Month 1: Week 4 | 14.3 Percentage of Participants |
| CNTO 2476 3.0*10^5 Cells | Percentage of Participants Losing Greater Than or Equal to (>=) 15 Best Corrected Visual Acuity Letters: Treated Eye | Month 2 | 14.3 Percentage of Participants |
| CNTO 2476 3.0*10^5 Cells | Percentage of Participants Losing Greater Than or Equal to (>=) 15 Best Corrected Visual Acuity Letters: Treated Eye | Month 3 | 19.0 Percentage of Participants |
| CNTO 2476 3.0*10^5 Cells | Percentage of Participants Losing Greater Than or Equal to (>=) 15 Best Corrected Visual Acuity Letters: Treated Eye | Month 6 | 14.3 Percentage of Participants |
| CNTO 2476 3.0*10^5 Cells | Percentage of Participants Losing Greater Than or Equal to (>=) 15 Best Corrected Visual Acuity Letters: Treated Eye | Month 12 | 16.7 Percentage of Participants |
| CNTO 2476 3.0*10^5 Cells | Percentage of Participants Losing Greater Than or Equal to (>=) 15 Best Corrected Visual Acuity Letters: Treated Eye | Month 18 | 17.6 Percentage of Participants |
| CNTO 2476 3.0*10^5 Cells | Percentage of Participants Losing Greater Than or Equal to (>=) 15 Best Corrected Visual Acuity Letters: Treated Eye | Month 24 | 20.0 Percentage of Participants |
| CNTO 2476 3.0*10^5 Cells | Percentage of Participants Losing Greater Than or Equal to (>=) 15 Best Corrected Visual Acuity Letters: Treated Eye | Month 30 | 23.1 Percentage of Participants |
| CNTO 2476 3.0*10^5 Cells | Percentage of Participants Losing Greater Than or Equal to (>=) 15 Best Corrected Visual Acuity Letters: Treated Eye | Month 36 | 30.8 Percentage of Participants |