September 2016
Volume 57, Issue 12
Open Access
ARVO Annual Meeting Abstract  |   September 2016
Health-related Quality of Life in Patients with moderate to advanced dry Age-related Macular Degeneration: Results from a Phase 1/2a clinical trial of CNTO 2476
Author Affiliations & Notes
  • Renee Pierson
    Janssen Pharmaceutica, Raritan, New Jersey, United States
  • Susan C Orr
    Janssen Pharmaceutica, Raritan, New Jersey, United States
  • Jennifer Bogert
    Janssen Research & Development, Raritan, New Jersey, United States
  • Allen Ho
    Wills Eye Hospital, Philadelphia, Pennsylvania, United States
  • Terri Malone
    Janssen Research & Development, Raritan, New Jersey, United States
  • Ross Crosby
    Health Outomes Solutions, Winter Park, Florida, United States
  • Susan Mathias
    Health Outomes Solutions, Winter Park, Florida, United States
  • Tom Chang
    Retina Institute of California, Arcadia, California, United States
  • Footnotes
    Commercial Relationships   Renee Pierson, Janssen (E); Susan Orr, Janssen (E); Jennifer Bogert, Janssen (E); Allen Ho, Janssen Research & Development, LLC (C); Terri Malone, Janssen (E); Ross Crosby, Janssen (C); Susan Mathias, Janssen (C); Tom Chang, Janssen Research & Development, LLC (C)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science September 2016, Vol.57, 5603. doi:
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    • Get Citation

      Renee Pierson, Susan C Orr, Jennifer Bogert, Allen Ho, Terri Malone, Ross Crosby, Susan Mathias, Tom Chang; Health-related Quality of Life in Patients with moderate to advanced dry Age-related Macular Degeneration: Results from a Phase 1/2a clinical trial of CNTO 2476. Invest. Ophthalmol. Vis. Sci. 2016;57(12):5603.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : Geographic atrophy (GA) is a form of moderate to advanced dry age-related macular degeneration (AMD) associated with central vision loss and gradual progression without regression. Since there is no approved treatment available for dry AMD, vitamin supplements with high doses of antioxidants, lutein, and zeaxanthin are used to slow progression and improve visual acuity. A new investigational product, CNTO 2476, consisting of human single donor umbilical tissue-derived cells, is now being tested.

Methods : As part of a recent Phase 1/2a multicenter, randomized, single dose, dose escalation, fellow-eye controlled study of a single subretinal administration of CNTO 2476 into the eye with worse visual acuity or the one selected by the investigator, the NEI-VFQ was interviewer-administered to each subject upon entry into the study, and at 6 month intervals. Change scores for the NEI-VFQ from baseline to each follow-up assessment were calculated for each subscale score and the total composite score. In addition, the percent of subjects experiencing significant deterioration (defined as a decline > 10 points) and the time to clinically meaningful deterioration in NEI-VFQ scores were also evaluated.

Results : 32 subjects (53% female, mean age 81 + 7, mean maximum reading speed in treated eye 32 + 35 wpm, GA area 16 + 9 m2) with moderate to severe GA in both eyes secondary to AMD completed the VFQ-25 at baseline and at months 6, 12, 24 and 36. No scores showed statistical significant improvement during the first 12 months. The % of subjects experiencing a clinically meaningful decline and mean time to a decline are shown in Table 1. General Vision and Near Activities subscales had the lowest % of subjects experiencing a clinically meaningful decline and the lowest rate to the decline.

Conclusions : Results from this study provide preliminary evidence that CNTO 2476 may provide some protective benefit in terms of General Vision and Near Activities.

This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.

 

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