PRELUDE: A Study to Evaluate the Safety and Clinical Response of Subretinal Administration of CNTO 2476 in Participants With Geographic Atrophy

• Sponsor: Janssen Research & Development, LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02659098
• Collaborator: (none)
• Enrollment: 21
• Locations: 8
• Arm: 1
• Actual Duration (Months): 42
• Patients Per Site: 2.6
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and performance profile of the suprachoroidal surgical approach and the Delivery System.

Condition or Disease	Intervention/Treatment	Phase
Visual Acuity; Geographic Atrophy; Macular Degeneration	Drug: CNTO 2476 3.0 x 10^5 cells; Device: Subretinal Delivery System	Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 21 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 2b, Multicenter, Double-masked, Randomized Study Evaluating the Safety and Clinical Response of Subretinal Administration of CNTO 2476 in Subjects With Visual Acuity Impairment Associated With Geographic Atrophy Secondary to Age Related Macular Degeneration
• Actual Study Start Date: Dec 4, 2015
• Actual Primary Completion Date: Jun 5, 2019
• Actual Study Completion Date: Jun 5, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Open-Label Safety Run-in Phase: Treatment Group Participants will receive CNTO 2476 3.0 x 10^5 cells in 50 microliter (mcL). CNTO 2476 will be delivered using the custom-designed Delivery System.	Drug: CNTO 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.; Device: Subretinal Delivery System; Participants will receive CNTO 2476 by using the Delivery System.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.

11. 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.

12. 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.

13. 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.

14. 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.

15. 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.

16. 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.

17. 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.

18. 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.

Secondary Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. 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).

6. 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).

7. 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.

8. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Arcadia	California	United States
2		Chicago	Illinois	United States
3		Lexington	Kentucky	United States
4		Boston	Massachusetts	United States
5		Royal Oak	Michigan	United States
6		Cincinnati	Ohio	United States
7		Philadelphia	Pennsylvania	United States
8		Dallas	Texas	United States

Sponsors and Collaborators

• Janssen Research & Development, LLC

Investigators

• Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study Documents (Full-Text)

• Study Protocol - Dec 15, 2017
• Statistical Analysis Plan - Jan 22, 2019

More Information

Publications

None provided.

• Responsible Party: Janssen Research & Development, LLC
• ClinicalTrials.gov Identifier: NCT02659098
• Other Study ID Numbers: CR106814; CNTO2476MDG2002
• First Posted: Jan 20, 2016
• Last Update Posted: Jun 23, 2020
• Last Verified: Jun 1, 2020

• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Janssen Research & Development, LLC: Best Corrected Visual Acuity; Geographic Atrophy; Macular Degeneration; CNTO 2476
• Additional relevant MeSH terms: Macular Degeneration; Geographic Atrophy; Atrophy

Study Results

Participant Flow

Arm/Group Title	CNTO 2476 3.0*10^5 Cells
Arm/Group Description	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.
Period Title: Overall Study
STARTED	21
COMPLETED	14
NOT COMPLETED	7

Baseline Characteristics

Arm/Group Title	CNTO 2476 3.0*10^5 Cells
Arm/Group Description	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.
Overall Participants	21
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	76.9 (10.12)
Sex: Female, Male (Count of Participants)
Female	15 71.4%
Male	6 28.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	21 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	21 100%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (Count of Participants)
UNITED STATES	21 100%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Best Corrected Visual Acuity (BCVA) Total Letters Score at Month 1- Treated Eye
Description	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

Outcome Measure Data

Analysis Population Description

The safety analysis set defined as participants who were enrolled and received surgery in the study.

Arm/Group Title	CNTO 2476 3.0*10^5 Cells
Arm/Group Description	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.
Measure Participants	21
Mean (Standard Deviation) [logMAR]	0.132 (0.2093)

2. Primary Outcome

Title	Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 2- Treated Eye
Description	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

Outcome Measure Data

Analysis Population Description

The safety analysis set defined as participants who were enrolled and received surgery in the study.

Arm/Group Title	CNTO 2476 3.0*10^5 Cells
Arm/Group Description	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.
Measure Participants	21
Mean (Standard Deviation) [logMAR]	0.073 (0.2273)

3. Primary Outcome

Title	Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 3- Treated Eye
Description	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

Outcome Measure Data

Analysis Population Description

The safety analysis set defined as participants who were enrolled and received surgery in the study.

Arm/Group Title	CNTO 2476 3.0*10^5 Cells
Arm/Group Description	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.
Measure Participants	21
Mean (Standard Deviation) [logMAR]	0.079 (0.2502)

4. Primary Outcome

Title	Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 6- Treated Eye
Description	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

Outcome Measure Data

Analysis Population Description

The safety analysis set defined as participants who were enrolled and received surgery in the study.

Arm/Group Title	CNTO 2476 3.0*10^5 Cells
Arm/Group Description	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.
Measure Participants	21
Mean (Standard Deviation) [logMAR]	0.090 (0.2628)

5. Primary Outcome

Title	Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 12- Treated Eye
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	CNTO 2476 3.0*10^5 Cells
Arm/Group Description	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.
Measure Participants	18
Mean (Standard Deviation) [logMAR]	0.119 (0.2598)

6. Primary Outcome

Title	Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 18- Treated Eye
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	CNTO 2476 3.0*10^5 Cells
Arm/Group Description	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.
Measure Participants	17
Mean (Standard Deviation) [logMAR]	0.107 (0.2512)

7. Primary Outcome

Title	Change From Baseline in Best Corrected Visual Acuity (BCVA) Total Letters Score at Month 24- Treated Eye
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	CNTO 2476 3.0*10^5 Cells
Arm/Group Description	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.
Measure Participants	15
Mean (Standard Deviation) [logMAR]	0.145 (0.3065)

8. Primary Outcome

Title	Change From Baseline in Best Corrected Visual Acuity (BCVA) Total Letters Score at Month 30- Treated Eye
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	CNTO 2476 3.0*10^5 Cells
Arm/Group Description	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.
Measure Participants	13
Mean (Standard Deviation) [logMAR]	0.112 (0.3093)

9. Primary Outcome

Title	Change From Baseline in Best Corrected Visual Acuity (BCVA) Total Letters Score at Month 36- Treated Eye
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	CNTO 2476 3.0*10^5 Cells
Arm/Group Description	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.
Measure Participants	13
Mean (Standard Deviation) [logMAR]	0.211 (0.3639)

10. Primary Outcome

Title	Change From Baseline in Best Corrected Visual Acuity (BCVA) Total Letters Score at Month 1- Fellow Eye
Description	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

Outcome Measure Data

Analysis Population Description

The safety analysis set defined as participants who were enrolled and received surgery in the study.

Arm/Group Title	CNTO 2476 3.0*10^5 Cells
Arm/Group Description	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.
Measure Participants	21
Mean (Standard Deviation) [logMAR]	0.017 (0.0962)

11. Primary Outcome

Title	Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 2- Fellow Eye
Description	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

Outcome Measure Data

Analysis Population Description

The safety analysis set defined as participants who were enrolled and received surgery in the study.

Arm/Group Title	CNTO 2476 3.0*10^5 Cells
Arm/Group Description	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.
Measure Participants	21
Mean (Standard Deviation) [logMAR]	0.027 (0.0868)

12. Primary Outcome

Title	Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 3- Fellow Eye
Description	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

Outcome Measure Data

Analysis Population Description

The safety analysis set defined as participants who were enrolled and received surgery in the study.

Arm/Group Title	CNTO 2476 3.0*10^5 Cells
Arm/Group Description	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.
Measure Participants	21
Mean (Standard Deviation) [logMAR]	0.010 (0.0960)

13. Primary Outcome

Title	Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 6- Fellow Eye
Description	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

Outcome Measure Data

Analysis Population Description

The safety analysis set defined as participants who were enrolled and received surgery in the study.

Arm/Group Title	CNTO 2476 3.0*10^5 Cells
Arm/Group Description	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.
Measure Participants	21
Mean (Standard Deviation) [logMAR]	0.033 (0.1351)

14. Primary Outcome

Title	Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 12- Fellow Eye
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	CNTO 2476 3.0*10^5 Cells
Arm/Group Description	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.
Measure Participants	18
Mean (Standard Deviation) [logMAR]	0.074 (0.1807)

15. Primary Outcome

Title	Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 18- Fellow Eye
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	CNTO 2476 3.0*10^5 Cells
Arm/Group Description	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.
Measure Participants	17
Mean (Standard Deviation) [logMAR]	0.075 (0.1728)

16. Primary Outcome

Title	Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 24- Fellow Eye
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	CNTO 2476 3.0*10^5 Cells
Arm/Group Description	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.
Measure Participants	15
Mean (Standard Deviation) [logMAR]	0.115 (0.1962)

17. Primary Outcome

Title	Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 30- Fellow Eye
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	CNTO 2476 3.0*10^5 Cells
Arm/Group Description	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.
Measure Participants	14
Mean (Standard Deviation) [logMAR]	0.106 (0.1721)

18. Primary Outcome

Title	Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 36- Fellow Eye
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	CNTO 2476 3.0*10^5 Cells
Arm/Group Description	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.
Measure Participants	13
Mean (Standard Deviation) [logMAR]	0.309 (0.2435)

19. Secondary Outcome

Title	Percentage of Participants Losing Greater Than or Equal to (>=) 15 Best Corrected Visual Acuity Letters: Treated Eye
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	CNTO 2476 3.0*10^5 Cells
Arm/Group Description	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.
Measure Participants	21
Month 1: Week 4	14.3 68.1%
Month 2	14.3 68.1%
Month 3	19.0 90.5%
Month 6	14.3 68.1%
Month 12	16.7 79.5%
Month 18	17.6 83.8%
Month 24	20.0 95.2%
Month 30	23.1 110%
Month 36	30.8 146.7%

20. Secondary Outcome

Title	Percentage of Participants Losing >=15 Best Corrected Visual Acuity Letters: Fellow Eye
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	CNTO 2476 3.0*10^5 Cells
Arm/Group Description	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.
Measure Participants	21
Month 1: Week 4	0 0%
Month 2	0 0%
Month 3	0 0%
Month 6	4.8 22.9%
Month 12	16.7 79.5%
Month 18	17.6 83.8%
Month 24	13.3 63.3%
Month 30	14.3 68.1%
Month 36	46.2 220%

21. Secondary Outcome

Title	Change From Baseline in Best Corrected Visual Acuity Letters at Months 6 and 12: Treated Eye
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	CNTO 2476 3.0*10^5 Cells
Arm/Group Description	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.
Measure Participants	21
Month 6	-4.5 (13.14)
Month 12	-5.9 (12.99)

22. Secondary Outcome

Title	Change From Baseline in Best Corrected Visual Acuity at Months 6 and 12: Fellow Eye
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	CNTO 2476 3.0*10^5 Cells
Arm/Group Description	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.
Measure Participants	21
Month 6	-1.7 (6.76)
Month 12	6.76 (9.03)

23. Secondary Outcome

Title	Change From Baseline in Growth Rate of Geographic Atrophy (GA) Lesion Area at Months 6 and 12: Treated Eye
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	CNTO 2476 3.0*10^5 Cells
Arm/Group Description	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.
Measure Participants	17
Month 6	0.6691 (2.3301)
Month 12	2.4214 (1.3661)

24. Secondary Outcome

Title	Change From Baseline in Growth Rate of Geographic Atrophy Lesion Area at Months 6 and 12: Fellow Eye
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	CNTO 2476 3.0*10^5 Cells
Arm/Group Description	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.
Measure Participants	13
Month 6	1.2085 (0.7060)
Month 12	2.6457 (1.9449)

25. Secondary Outcome

Title	Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Description	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

Outcome Measure Data

Analysis Population Description

The safety analysis set defined as participants who were enrolled and received surgery in the study.

Arm/Group Title	CNTO 2476 3.0*10^5 Cells
Arm/Group Description	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.
Measure Participants	21
Treatment-emergent Adverse Events	20 95.2%
Treatment-emergent Serious Adverse Events	5 23.8%

26. Secondary Outcome

Title	Number of Participants With Ocular Treatment-emergent Adverse Events
Description	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

Outcome Measure Data

Analysis Population Description

The safety analysis set defined as participants who were enrolled and received surgery in the study.

Arm/Group Title	CNTO 2476 3.0*10^5 Cells
Arm/Group Description	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.
Measure Participants	21
Treated Eye	17 81%
Fellow Eye	10 47.6%

Adverse Events

Time Frame	Up to 36 Months
Adverse Event Reporting Description	The safety analysis set defined as participants who were enrolled and received surgery in the study.
Arm/Group Title	CNTO 2476 3.0*10^5 Cells
Arm/Group Description	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.
All Cause Mortality
	CNTO 2476 3.0*10^5 Cells
	Affected / at Risk (%)	# Events
Total	0/21 (0%)
Serious Adverse Events
	CNTO 2476 3.0*10^5 Cells
	Affected / at Risk (%)	# Events
Total	5/21 (23.8%)
Blood and lymphatic system disorders
Haemorrhagic Anaemia	1/21 (4.8%)
Cardiac disorders
Aortic Valve Stenosis	1/21 (4.8%)
Atrial Fibrillation	1/21 (4.8%)
Musculoskeletal and connective tissue disorders
Osteoarthritis	1/21 (4.8%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant	1/21 (4.8%)
Nervous system disorders
Subarachnoid Haemorrhage	1/21 (4.8%)
Syncope	1/21 (4.8%)
Other (Not Including Serious) Adverse Events
	CNTO 2476 3.0*10^5 Cells
	Affected / at Risk (%)	# Events
Total	18/21 (85.7%)
Cardiac disorders
Atrial Fibrillation	2/21 (9.5%)
Eye disorders
Anterior Chamber Cell	2/21 (9.5%)
Cataract	2/21 (9.5%)
Cataract Nuclear	3/21 (14.3%)
Charles Bonnet Syndrome	2/21 (9.5%)
Conjunctival Haemorrhage	9/21 (42.9%)
Conjunctival Oedema	2/21 (9.5%)
Neovascular Age-Related Macular Degeneration	3/21 (14.3%)
Retinal Haemorrhage	7/21 (33.3%)
Visual Acuity Reduced	5/21 (23.8%)
Visual Impairment	2/21 (9.5%)
Vitreous Detachment	2/21 (9.5%)
Vitreous Floaters	4/21 (19%)
General disorders
Sensation of Foreign Body	5/21 (23.8%)
Infections and infestations
Urinary Tract Infection	2/21 (9.5%)
Injury, poisoning and procedural complications
Contusion	2/21 (9.5%)
Corneal Abrasion	2/21 (9.5%)
Fall	2/21 (9.5%)
Vascular disorders
Hypertension	3/21 (14.3%)

Limitations/Caveats

Protocol Amendment 3 eliminated 2nd safety cohort and randomized masked portion of study per Sponsor decision to terminate development. Protocol specified follow-up visits were completed for treated participants, thus study was considered completed.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.