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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02659098
Recruitment Status : Completed
First Posted : January 20, 2016
Results First Posted : June 23, 2020
Last Update Posted : June 23, 2020
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Visual Acuity
Geographic Atrophy
Macular Degeneration
Interventions Drug: CNTO 2476 3.0 x 10^5 cells
Device: Subretinal Delivery System
Enrollment 21
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CNTO 2476 3.0*10^5 Cells
Hide 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
Reason Not Completed
Withdrawal by Subject             7
Arm/Group Title CNTO 2476 3.0*10^5 Cells
Hide 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 Number of Baseline Participants 21
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants
76.9  (10.12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
Female
15
  71.4%
Male
6
  28.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
21
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
21
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
UNITED STATES Number Analyzed 21 participants
21
 100.0%
1.Primary Outcome
Title Change From Baseline in Best Corrected Visual Acuity (BCVA) Total Letters Score at Month 1- Treated Eye
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 21
Mean (Standard Deviation)
Unit of Measure: 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 21
Mean (Standard Deviation)
Unit of Measure: 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 21
Mean (Standard Deviation)
Unit of Measure: 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 21
Mean (Standard Deviation)
Unit of Measure: 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 21
Mean (Standard Deviation)
Unit of Measure: 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 21
Mean (Standard Deviation)
Unit of Measure: 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 21
Mean (Standard Deviation)
Unit of Measure: 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 21
Mean (Standard Deviation)
Unit of Measure: 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 21
Measure Type: Number
Unit of Measure: Percentage of Participants
Month 1: Week 4 Number Analyzed 21 participants
14.3
Month 2 Number Analyzed 21 participants
14.3
Month 3 Number Analyzed 21 participants
19.0
Month 6 Number Analyzed 21 participants
14.3
Month 12 Number Analyzed 18 participants
16.7
Month 18 Number Analyzed 17 participants
17.6
Month 24 Number Analyzed 15 participants
20.0
Month 30 Number Analyzed 13 participants
23.1
Month 36 Number Analyzed 13 participants
30.8
20.Secondary Outcome
Title Percentage of Participants Losing >=15 Best Corrected Visual Acuity Letters: Fellow Eye
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 21
Measure Type: Number
Unit of Measure: Percentage of Participants
Month 1: Week 4 Number Analyzed 21 participants
0
Month 2 Number Analyzed 21 participants
0
Month 3 Number Analyzed 21 participants
0
Month 6 Number Analyzed 21 participants
4.8
Month 12 Number Analyzed 18 participants
16.7
Month 18 Number Analyzed 17 participants
17.6
Month 24 Number Analyzed 15 participants
13.3
Month 30 Number Analyzed 14 participants
14.3
Month 36 Number Analyzed 13 participants
46.2
21.Secondary Outcome
Title Change From Baseline in Best Corrected Visual Acuity Letters at Months 6 and 12: Treated Eye
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 21
Mean (Standard Deviation)
Unit of Measure: Letters
Month 6 Number Analyzed 21 participants
-4.5  (13.14)
Month 12 Number Analyzed 18 participants
-5.9  (12.99)
22.Secondary Outcome
Title Change From Baseline in Best Corrected Visual Acuity at Months 6 and 12: Fellow Eye
Hide 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
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Hide 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
Hide 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 Number of Participants Analyzed 21
Mean (Standard Deviation)
Unit of Measure: Letters
Month 6 Number Analyzed 21 participants
-1.7  (6.76)
Month 12 Number Analyzed 18 participants
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: Square millimeter
Month 6 Number Analyzed 17 participants
0.6691  (2.3301)
Month 12 Number Analyzed 11 participants
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: Square millimeter
Month 6 Number Analyzed 12 participants
1.2085  (0.7060)
Month 12 Number Analyzed 13 participants
2.6457  (1.9449)
25.Secondary Outcome
Title Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 21
Measure Type: Count of Participants
Unit of Measure: Participants
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 21
Measure Type: Count of Participants
Unit of Measure: Participants
Treated Eye
17
  81.0%
Fellow Eye
10
  47.6%
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
Hide 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 (%)
Total   0/21 (0.00%) 
Hide Serious Adverse Events
CNTO 2476 3.0*10^5 Cells
Affected / at Risk (%)
Total   5/21 (23.81%) 
Blood and lymphatic system disorders   
Haemorrhagic Anaemia * 1  1/21 (4.76%) 
Cardiac disorders   
Aortic Valve Stenosis * 1  1/21 (4.76%) 
Atrial Fibrillation * 1  1/21 (4.76%) 
Musculoskeletal and connective tissue disorders   
Osteoarthritis * 1  1/21 (4.76%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Lung Neoplasm Malignant * 1  1/21 (4.76%) 
Nervous system disorders   
Subarachnoid Haemorrhage * 1  1/21 (4.76%) 
Syncope * 1  1/21 (4.76%) 
1
Term from vocabulary, MedDRA Version 19.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
CNTO 2476 3.0*10^5 Cells
Affected / at Risk (%)
Total   18/21 (85.71%) 
Cardiac disorders   
Atrial Fibrillation * 1  2/21 (9.52%) 
Eye disorders   
Anterior Chamber Cell * 1  2/21 (9.52%) 
Cataract * 1  2/21 (9.52%) 
Cataract Nuclear * 1  3/21 (14.29%) 
Charles Bonnet Syndrome * 1  2/21 (9.52%) 
Conjunctival Haemorrhage * 1  9/21 (42.86%) 
Conjunctival Oedema * 1  2/21 (9.52%) 
Neovascular Age-Related Macular Degeneration * 1  3/21 (14.29%) 
Retinal Haemorrhage * 1  7/21 (33.33%) 
Visual Acuity Reduced * 1  5/21 (23.81%) 
Visual Impairment * 1  2/21 (9.52%) 
Vitreous Detachment * 1  2/21 (9.52%) 
Vitreous Floaters * 1  4/21 (19.05%) 
General disorders   
Sensation of Foreign Body * 1  5/21 (23.81%) 
Infections and infestations   
Urinary Tract Infection * 1  2/21 (9.52%) 
Injury, poisoning and procedural complications   
Contusion * 1  2/21 (9.52%) 
Corneal Abrasion * 1  2/21 (9.52%) 
Fall * 1  2/21 (9.52%) 
Vascular disorders   
Hypertension * 1  3/21 (14.29%) 
1
Term from vocabulary, MedDRA Version 19.0
*
Indicates events were collected by non-systematic assessment
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Director
Organization: Janssen Research & Development, LLC
Phone: 844-434-4210
EMail: ClinicalTrialDisclosure@its.jnj.com
Layout table for additonal information
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02659098    
Other Study ID Numbers: CR106814
CNTO2476MDG2002 ( Other Identifier: Janssen Research & Development, LLC )
First Submitted: December 7, 2015
First Posted: January 20, 2016
Results First Submitted: June 2, 2020
Results First Posted: June 23, 2020
Last Update Posted: June 23, 2020