Trial Outcomes & Findings for A Study to Evaluate the Safety and Clinical Response of Subretinal Administration of CNTO 2476 in Participants With Geographic Atrophy (NCT NCT02659098)

NCT ID: NCT02659098

Last Updated: 2025-04-29

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 21 participants
• Primary outcome timeframe: Baseline and Month 1
• Results posted on: 2025-04-29

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	21
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Measure	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.
Overall Study Withdrawal by Subject	7

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	CNTO 2476 3.0*10^5 Cells n=21 Participants 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.
Age, Continuous	76.9 years STANDARD_DEVIATION 10.12 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment UNITED STATES	21 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Month 1

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

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.

Outcome measures

Measure	CNTO 2476 3.0*10^5 Cells n=21 Participants 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.
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 outcome

Timeframe: Baseline and Month 2

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

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.

Outcome measures

Measure	CNTO 2476 3.0*10^5 Cells n=21 Participants 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.
Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 2- Treated Eye	0.073 logMAR Standard Deviation 0.2273

PRIMARY outcome

Timeframe: Baseline and Month 3

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

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.

Outcome measures

Measure	CNTO 2476 3.0*10^5 Cells n=21 Participants 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.
Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 3- Treated Eye	0.079 logMAR Standard Deviation 0.2502

PRIMARY outcome

Timeframe: Baseline and Month 6

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

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.

Outcome measures

Measure	CNTO 2476 3.0*10^5 Cells n=21 Participants 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.
Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 6- Treated Eye	0.090 logMAR Standard Deviation 0.2628

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	CNTO 2476 3.0*10^5 Cells n=18 Participants 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.
Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 12- Treated Eye	0.119 logMAR Standard Deviation 0.2598

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	CNTO 2476 3.0*10^5 Cells n=17 Participants 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.
Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 18- Treated Eye	0.107 logMAR Standard Deviation 0.2512

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	CNTO 2476 3.0*10^5 Cells n=15 Participants 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.
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 outcome

Timeframe: 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.

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.

Outcome measures

Measure	CNTO 2476 3.0*10^5 Cells n=13 Participants 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.
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 outcome

Timeframe: 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.

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.

Outcome measures

Measure	CNTO 2476 3.0*10^5 Cells n=13 Participants 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.
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 outcome

Timeframe: Baseline and Month 1

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

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.

Outcome measures

Measure	CNTO 2476 3.0*10^5 Cells n=21 Participants 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.
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 outcome

Timeframe: Baseline and Month 2

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

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.

Outcome measures

Measure	CNTO 2476 3.0*10^5 Cells n=21 Participants 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.
Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 2- Fellow Eye	0.027 logMAR Standard Deviation 0.0868

PRIMARY outcome

Timeframe: Baseline and Month 3

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

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.

Outcome measures

Measure	CNTO 2476 3.0*10^5 Cells n=21 Participants 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.
Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 3- Fellow Eye	0.010 logMAR Standard Deviation 0.0960

PRIMARY outcome

Timeframe: Baseline and Month 6

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

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.

Outcome measures

Measure	CNTO 2476 3.0*10^5 Cells n=21 Participants 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.
Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 6- Fellow Eye	0.033 logMAR Standard Deviation 0.1351

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	CNTO 2476 3.0*10^5 Cells n=18 Participants 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.
Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 12- Fellow Eye	0.074 logMAR Standard Deviation 0.1807

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	CNTO 2476 3.0*10^5 Cells n=17 Participants 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.
Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 18- Fellow Eye	0.075 logMAR Standard Deviation 0.1728

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	CNTO 2476 3.0*10^5 Cells n=15 Participants 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.
Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 24- Fellow Eye	0.115 logMAR Standard Deviation 0.1962

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	CNTO 2476 3.0*10^5 Cells n=14 Participants 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.
Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 30- Fellow Eye	0.106 logMAR Standard Deviation 0.1721

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	CNTO 2476 3.0*10^5 Cells n=13 Participants 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.
Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 36- Fellow Eye	0.309 logMAR Standard Deviation 0.2435

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	CNTO 2476 3.0*10^5 Cells n=21 Participants 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.
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
Percentage of Participants Losing Greater Than or Equal to (>=) 15 Best Corrected Visual Acuity Letters: Treated Eye Month 2	14.3 Percentage of Participants
Percentage of Participants Losing Greater Than or Equal to (>=) 15 Best Corrected Visual Acuity Letters: Treated Eye Month 3	19.0 Percentage of Participants
Percentage of Participants Losing Greater Than or Equal to (>=) 15 Best Corrected Visual Acuity Letters: Treated Eye Month 6	14.3 Percentage of Participants
Percentage of Participants Losing Greater Than or Equal to (>=) 15 Best Corrected Visual Acuity Letters: Treated Eye Month 12	16.7 Percentage of Participants
Percentage of Participants Losing Greater Than or Equal to (>=) 15 Best Corrected Visual Acuity Letters: Treated Eye Month 18	17.6 Percentage of Participants
Percentage of Participants Losing Greater Than or Equal to (>=) 15 Best Corrected Visual Acuity Letters: Treated Eye Month 24	20.0 Percentage of Participants
Percentage of Participants Losing Greater Than or Equal to (>=) 15 Best Corrected Visual Acuity Letters: Treated Eye Month 30	23.1 Percentage of Participants
Percentage of Participants Losing Greater Than or Equal to (>=) 15 Best Corrected Visual Acuity Letters: Treated Eye Month 36	30.8 Percentage of Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	CNTO 2476 3.0*10^5 Cells n=21 Participants 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.
Percentage of Participants Losing >=15 Best Corrected Visual Acuity Letters: Fellow Eye Month 6	4.8 Percentage of Participants
Percentage of Participants Losing >=15 Best Corrected Visual Acuity Letters: Fellow Eye Month 12	16.7 Percentage of Participants
Percentage of Participants Losing >=15 Best Corrected Visual Acuity Letters: Fellow Eye Month 18	17.6 Percentage of Participants
Percentage of Participants Losing >=15 Best Corrected Visual Acuity Letters: Fellow Eye Month 24	13.3 Percentage of Participants
Percentage of Participants Losing >=15 Best Corrected Visual Acuity Letters: Fellow Eye Month 30	14.3 Percentage of Participants
Percentage of Participants Losing >=15 Best Corrected Visual Acuity Letters: Fellow Eye Month 36	46.2 Percentage of Participants
Percentage of Participants Losing >=15 Best Corrected Visual Acuity Letters: Fellow Eye Month 1: Week 4	0 Percentage of Participants
Percentage of Participants Losing >=15 Best Corrected Visual Acuity Letters: Fellow Eye Month 2	0 Percentage of Participants
Percentage of Participants Losing >=15 Best Corrected Visual Acuity Letters: Fellow Eye Month 3	0 Percentage of Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	CNTO 2476 3.0*10^5 Cells n=21 Participants 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.
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
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 outcome

Timeframe: 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.

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.

Outcome measures

Measure	CNTO 2476 3.0*10^5 Cells n=21 Participants 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.
Change From Baseline in Best Corrected Visual Acuity at Months 6 and 12: Fellow Eye Month 6	-1.7 Letters Standard Deviation 6.76
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 outcome

Timeframe: 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.

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).

Outcome measures

Measure	CNTO 2476 3.0*10^5 Cells n=17 Participants 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.
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
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 outcome

Timeframe: 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.

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).

Outcome measures

Measure	CNTO 2476 3.0*10^5 Cells n=13 Participants 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.
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 0.7060
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 outcome

Timeframe: Up to Months 36

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

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.

Outcome measures

Measure	CNTO 2476 3.0*10^5 Cells n=21 Participants 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.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Treatment-emergent Adverse Events	20 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Treatment-emergent Serious Adverse Events	5 Participants

SECONDARY outcome

Timeframe: Up to Months 36

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

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.

Outcome measures

Measure	CNTO 2476 3.0*10^5 Cells n=21 Participants 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.
Number of Participants With Ocular Treatment-emergent Adverse Events Treated Eye	17 Participants
Number of Participants With Ocular Treatment-emergent Adverse Events Fellow Eye	10 Participants

Adverse Events

CNTO 2476 3.0*10^5 Cells

Serious events: 5 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Measure	CNTO 2476 3.0*10^5 Cells n=21 participants at risk 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.
Blood and lymphatic system disorders Haemorrhagic Anaemia	4.8% 1/21 • Up to 36 Months The safety analysis set defined as participants who were enrolled and received surgery in the study.
Cardiac disorders Aortic Valve Stenosis	4.8% 1/21 • Up to 36 Months The safety analysis set defined as participants who were enrolled and received surgery in the study.
Cardiac disorders Atrial Fibrillation	4.8% 1/21 • Up to 36 Months The safety analysis set defined as participants who were enrolled and received surgery in the study.
Musculoskeletal and connective tissue disorders Osteoarthritis	4.8% 1/21 • Up to 36 Months The safety analysis set defined as participants who were enrolled and received surgery in the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Neoplasm Malignant	4.8% 1/21 • Up to 36 Months The safety analysis set defined as participants who were enrolled and received surgery in the study.
Nervous system disorders Subarachnoid Haemorrhage	4.8% 1/21 • Up to 36 Months The safety analysis set defined as participants who were enrolled and received surgery in the study.
Nervous system disorders Syncope	4.8% 1/21 • Up to 36 Months The safety analysis set defined as participants who were enrolled and received surgery in the study.

Other adverse events

Measure	CNTO 2476 3.0*10^5 Cells n=21 participants at risk 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.
Cardiac disorders Atrial Fibrillation	9.5% 2/21 • Up to 36 Months The safety analysis set defined as participants who were enrolled and received surgery in the study.
Eye disorders Anterior Chamber Cell	9.5% 2/21 • Up to 36 Months The safety analysis set defined as participants who were enrolled and received surgery in the study.
Eye disorders Cataract	9.5% 2/21 • Up to 36 Months The safety analysis set defined as participants who were enrolled and received surgery in the study.
Eye disorders Cataract Nuclear	14.3% 3/21 • Up to 36 Months The safety analysis set defined as participants who were enrolled and received surgery in the study.
Eye disorders Charles Bonnet Syndrome	9.5% 2/21 • Up to 36 Months The safety analysis set defined as participants who were enrolled and received surgery in the study.
Eye disorders Conjunctival Haemorrhage	42.9% 9/21 • Up to 36 Months The safety analysis set defined as participants who were enrolled and received surgery in the study.
Eye disorders Conjunctival Oedema	9.5% 2/21 • Up to 36 Months The safety analysis set defined as participants who were enrolled and received surgery in the study.
Eye disorders Neovascular Age-Related Macular Degeneration	14.3% 3/21 • Up to 36 Months The safety analysis set defined as participants who were enrolled and received surgery in the study.
Eye disorders Retinal Haemorrhage	33.3% 7/21 • Up to 36 Months The safety analysis set defined as participants who were enrolled and received surgery in the study.
Eye disorders Visual Acuity Reduced	23.8% 5/21 • Up to 36 Months The safety analysis set defined as participants who were enrolled and received surgery in the study.
Eye disorders Visual Impairment	9.5% 2/21 • Up to 36 Months The safety analysis set defined as participants who were enrolled and received surgery in the study.
Eye disorders Vitreous Detachment	9.5% 2/21 • Up to 36 Months The safety analysis set defined as participants who were enrolled and received surgery in the study.
Eye disorders Vitreous Floaters	19.0% 4/21 • Up to 36 Months The safety analysis set defined as participants who were enrolled and received surgery in the study.
General disorders Sensation of Foreign Body	23.8% 5/21 • Up to 36 Months The safety analysis set defined as participants who were enrolled and received surgery in the study.
Infections and infestations Urinary Tract Infection	9.5% 2/21 • Up to 36 Months The safety analysis set defined as participants who were enrolled and received surgery in the study.
Injury, poisoning and procedural complications Contusion	9.5% 2/21 • Up to 36 Months The safety analysis set defined as participants who were enrolled and received surgery in the study.
Injury, poisoning and procedural complications Corneal Abrasion	9.5% 2/21 • Up to 36 Months The safety analysis set defined as participants who were enrolled and received surgery in the study.
Injury, poisoning and procedural complications Fall	9.5% 2/21 • Up to 36 Months The safety analysis set defined as participants who were enrolled and received surgery in the study.
Vascular disorders Hypertension	14.3% 3/21 • Up to 36 Months The safety analysis set defined as participants who were enrolled and received surgery in the study.

Additional Information

Senior Director

Janssen Research & Development, LLC

Phone: 844-434-4210

Email: ClinicalTrialDisclosure@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER