Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CNTO2476MDG2003 | Other Identifier | Janssen Pharmaceutical K.K., Japan |
Not provided
Not provided
Not provided
Company business decision
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to evaluate the efficacy and safety of CNTO 2476 cells administered into the subretinal space by the suprachoroidal surgical approach and the subretinal access kit (SRAK-02) in participants with visual acuity impairment associated with Geographic Atrophy (GA) secondary to Age Related Macular Degeneration (AMD).
This is a Phase 2 study to evaluate the efficacy and safety of a single subretinal administration of CNTO 2476 compared with the untreated control group, as well as to assess the safety and usability profile of the procedure and the device for cell therapy delivery in participants with visual acuity impairment associated with Geographic Atrophy (GA) secondary to Age Related Macular Degeneration (AMD). The duration of participation in the study for each participant is approximately 3 years. Efficacy will be evaluated at 6 month, 12 months and every 6 month thereafter. Participant's safety will be monitored throughout the study.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CNTO 2476 (6.0 * 10^4 cells) | Experimental | Participants will receive a single subretinal administration of CNTO 2476 (6.0 * 10^4 cells) in 50 microliter (mcL) given by subretinal delivery system. |
|
| CNTO 2476 (3.0 * 10^5 cells) | Experimental | Participants will receive a single subretinal administration of CNTO 2476 (3.0 * 10^5 cells) in 50 mcL given by subretinal delivery system. |
|
| Control Group | No Intervention | Participants will undergo observations without surgery. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CNTO 2476 (6.0 * 10^4 cells) | Combination Product | Participants will receive a single subretinal administration of CNTO 2476 (6.0 * 10^4 cells) in 50 mcL given by subretinal delivery system (subretinal access kit [SRAK-02 kit] and third arm accessory). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Showing Improvement From Baseline of Greater Than or Equal to (>=) 15 Letters in Best Corrected Visual Acuity (BCVA) at Month 6 | The BCVA testing performed after refraction and under standardized photopic lighting conditions and distance using an Early Treatment Diabetic Retinopathy Study (ETDRS) log of the minimum angle of resolution (logMAR chart). The ETDRS chart at 4 meters is considered the 'gold standard' for visual acuity testing in clinical research for its physical and statistical properties. | Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Showing Improvement >=15 BCVA Letters From Baseline at 12 Month | Percentage of Participants Showing Improvement >=15 BCVA Letters From Baseline at 12 Month | Baseline and Month 12 |
| Percentage of Participants Losing >=15 Best Corrected Visual Acuity (BCVA) Letters From Baseline at 6 and 12 Months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Janssen Pharmaceutical K.K., Japan Clinical Trial | Janssen Pharmaceutical K.K. | Study Director |
Not provided
Not provided
Not provided
Not provided
Not provided
| CNTO 2476 (3.0 * 10^5 cells) | Combination Product | Participants will receive a single subretinal administration of CNTO 2476 (3.0 * 10^5 cells) in 50 mcL given by subretinal delivery system (SRAK-02 kit and third arm accessory). |
|
Percentage of Participants Losing >=15 Best Corrected Visual Acuity (BCVA) Letters From Baseline at 6 and 12 Months |
| Baseline, Month 6 and 12 |
| Change in Mean Number of BCVA Letters From Baseline at 6 and 12 Months | Change in Mean Number of BCVA Letters From Baseline at 6 and 12 Months | Baseline, Month 6 and 12 |
| Change in Growth Rate of Geographic Atrophy (GA) Lesion Documented at Baseline to 6 and 12 Months | The area of GA is determined based primarily on fundus autofluorescence (FAF) as well as fluorescein angiography and fundus photography. | Baseline, Month 6 and 12 |
| Mean Change in Reading Acuity (RA) From baseline to 6 and 12 Months | Minnesota reading test will be used to determine RA measured in log of the minimum angle of resolution (logMAR). | Baseline, Month 6 and 12 |
| Mean Change in Maximum Reading Speed (MRS) From Baseline to 6 and 12 Months | Minnesota reading test will be used to determine maximum reading speed (MRS, [measured in characters per minute]). | Baseline, Month 6 and 12 |
| Mean Change in Critical Print Size (CPS) From Baseline to 6 and 12 Months | Minnesota reading test will be used to determine CPS measured in log of the minimum angle of resolution (logMAR). | Baseline, Month 6 and 12 |
| Mean Change in Low Luminance Best Corrected Visual Acuity (LL BCVA) Letters From Baseline to 6 and 12 Months | Low Luminance BCVA indicates the best possible vision that an eye can achieve with the use of trial frames/lenses following refraction under low luminance conditions. | Baseline, Month 6 and 12 |
| Percentage of Participants With Gain of >= 15 Letters in LL BCVA From Baseline to 6 and 12 Months | Percentage of Participants With Gain of >= 15 Letters in LL BCVA From Baseline to 6 and 12 Months | Baseline, Month 6 and 12 |
| Mean Change in Contrast Sensitivity From Baseline to 6 and 12 Months | Mean Change in Contrast Sensitivity From Baseline to 6 and 12 Months | Baseline, Month 6 and 12 |
| Number of Participants With Significant Changes in Retinal Morphology | Number of Participants With Significant Changes in Retinal Morphology | Baseline, Month 6 and 12 |
| Percentage of Participants who Convert to Neovascular Age-Related Macular Degeneration (AMD) in the Study Eye and in the Fellow Eye | Percentage of Participants who Convert to Neovascular Age-Related Macular Degeneration (AMD) in the Study Eye and in the Fellow Eye | Baseline, Month 6 and 12 |
| Percentage of Participants who Achieved Technical Success in the Active Drug Group | Percentage of participants who achieved technical success in the active drug group will be evaluated and the criteria that must be met to achieve technical success are :1) The device was accessible to the suprachoroidal space, 2) Micro needle reached to the subretinal space, 3) When study drug injected into the subretinal space a) No retinal perforation was directly visualized by the surgeon following the formation of the bleb in the subretinal space after injecting the balanced salt solution (BSS) Plus, b) When 50 microliter (mcL) of study drug was administered subretinally, the creation of an enlarged bleb in the subretinal space is visualized by the surgeon, 4) Micro needle and the device were removed. | 6 Months |
| Percentage of Participants who Achieved Procedural Success in the Active Drug Group | Percentage of participants who achieved procedural success in the active drug group will be evaluated and the criteria that must be met to achieve procedural success : 1) Achievement of technical success, 2) Endophthalmitis, significant choroidal hemorrhage, leakage of cells or other need for vitrectomy, retinal detachment, and failure to deliver cells did not occur, 3) No device malfunction. | Month 6 and 12 |
| Number of Participants with Ocular Adverse Events (AEs) and Serious Adverse Events (SAEs) | Study treatment, device and surgical procedure-related ocular AEs and SAEs will be reported. | Up to Long term Follow up (Month 36) |
| Mean Change From Baseline at 6 and 12 Months in Participants Reported Health-Related Quality of Life as Assessed by Short Form (36) Health Survey | SF-36 is scored to produce 8 subscales (Physical Functioning, Role Limitations-Physical, Bodily Pain, General Health Perceptions, Vitality, Social Functioning, Role Limitations- Emotional, and Mental Health) and 2 summary scores (Physical Component Summary and Mental Component Summary). | Baseline, Month 6 and 12 |
| Mean Change From Baseline at 6 and 12 Months in Participants Reported Health Related Quality of Life as Assessed by Functional Reading Index Questionnaire (FRI) | The FRI is an interviewer-administered questionnaire with 7 items on functional reading activities most relevant to GA AMD participants. Item scores reflect decreasing levels of functional reading independence. The FRI Index yields continuous mean scores (range 1 to 4), and ordinal-level scores from Level 1 = "Unable to do" to Level 4 = "Totally independent." For each FRI Index reading activity performed in the past 7 days, participants are asked about the extent to which they required vision aids, adjustments in the activity, or help from another person. | Baseline, Month 6 and 12 |
| Incidence of Anti-CNTO 2476 Antibodies | Number of participants who develop antibodies. | Baseline, Day 7 and 15, Month 2, 3 and 6 |
| Mean Change From Baseline at 6 and 12 Months in Participants Reported Health-Related Quality of Life as Assessed by National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Score | The 2000 version of the NEI-VFQ-25, which must be interviewer-administered, includes 25 items and is scored to produce 11 subscales and a general health item. The 11 subscales include General Vision (1 item), Ocular Pain (2 items), Near Activities (3 items), Distance Activities (3 items), Social Functioning (2 items), Mental Health (2 items), Role Difficulties (2 items), Dependency (3 items), Driving (3 items), Color Vision (1 item), and Peripheral Vision (1 item). Response to each question converted to 0-100 score. Each subscale, total score equal to (=) average of items contributing to score. For each subscale and total score, score range: 0 to 100, higher score equal to less symptoms/better visual functioning. | Baseline, Month 6 and 12 |
| Mean Change From Baseline at 6 and 12 Months in Participants Reported Health-Related Quality of Life as Assessed by Near Vision Subscale Score | A 3-item Near Vision subscale score of National Eye Institute will evaluate quality of life. Response to each question converted to 0-100 score. Each subscale, total score equal to average of items contributing to score. For each subscale and total score, score range: 0 to 100, higher score equal to less symptoms/better visual functioning. | Baseline, Month 6 and 12 |
| ID | Term |
|---|---|
| D057092 | Geographic Atrophy |
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided