Efficacy and Safety Study of CNTO 2476 in Participants With Visual Acuity Impairment Associated With Geographic Atrophy (GA) Secondary to Age Related Macular Degeneration (AMD)

Browse trials for

• Geographic Atrophy 177
• Macular Degeneration 1,490

Geographic Atrophy

177 studies on the registry are indexed under Geographic Atrophy; 45 are open to participants now.

Lead sponsor

Janssen Pharmaceutical K.K. is the lead sponsor of 126 studies on the registry; none are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 7 (54%) have results posted.

Study arms

• Experimental
  CNTO 2476 (6.0 * 10^4 cells)

  Participants will receive a single subretinal administration of CNTO 2476 (6.0 \* 10\^4 cells) in 50 microliter (mcL) given by subretinal delivery system.

  Combination Product: CNTO 2476 (6.0 * 10^4 cells)

• Experimental
  CNTO 2476 (3.0 * 10^5 cells)

  Participants will receive a single subretinal administration of CNTO 2476 (3.0 \* 10\^5 cells) in 50 mcL given by subretinal delivery system.

  Combination Product: CNTO 2476 (3.0 * 10^5 cells)

• No intervention
  Control Group

  Participants will undergo observations without surgery.

Interventions

• Combination productCNTO 2476 (6.0 * 10^4 cells)

  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).

• Combination productCNTO 2476 (3.0 * 10^5 cells)

  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).

Primary outcomes

1. 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.

   Time frame: Month 6

Secondary outcomes

1. 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

   Time frame: Baseline and Month 12

2. Percentage of Participants Losing >=15 Best Corrected Visual Acuity (BCVA) Letters From Baseline at 6 and 12 Months

   Percentage of Participants Losing \>=15 Best Corrected Visual Acuity (BCVA) Letters From Baseline at 6 and 12 Months

   Time frame: Baseline, Month 6 and 12

3. 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

   Time frame: Baseline, Month 6 and 12

4. 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.

   Time frame: Baseline, Month 6 and 12

5. 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).

   Time frame: Baseline, Month 6 and 12

6. 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, \[measured in characters per minute\]).

   Time frame: Baseline, Month 6 and 12

7. 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).

   Time frame: Baseline, Month 6 and 12

8. 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.

   Time frame: Baseline, Month 6 and 12

9. 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

   Time frame: Baseline, Month 6 and 12

10. Mean Change in Contrast Sensitivity From Baseline to 6 and 12 Months

    Mean Change in Contrast Sensitivity From Baseline to 6 and 12 Months

    Time frame: Baseline, Month 6 and 12

11. Number of Participants With Significant Changes in Retinal Morphology

    Number of Participants With Significant Changes in Retinal Morphology

    Time frame: Baseline, Month 6 and 12

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

    Time frame: Baseline, Month 6 and 12

13. 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.

    Time frame: 6 Months

14. 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.

    Time frame: Month 6 and 12

15. 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.

    Time frame: Up to Long term Follow up (Month 36)

16. 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).

    Time frame: Baseline, Month 6 and 12

17. 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.

    Time frame: Baseline, Month 6 and 12

18. Incidence of Anti-CNTO 2476 Antibodies

    Number of participants who develop antibodies.

    Time frame: Baseline, Day 7 and 15, Month 2, 3 and 6

19. 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.

    Time frame: Baseline, Month 6 and 12

20. 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.

    Time frame: Baseline, Month 6 and 12