April 2011
Volume 52, Issue 14
Free
ARVO Annual Meeting Abstract  |   April 2011
A Phase 2 Study of Encapsulated CNTF-Secreting Cell Implant (NT-501) In Patients with Geographic Atrophy Associated with Dry AMD
Author Affiliations & Notes
  • Glenn J. Jaffe
    Ophthalmology, Duke University Eye Center, Durham, North Carolina
  • Jaque L. Duncan
    Ophthalmology, UC San Francisco, San Francisco, California
  • Weng Tao
    Neurotech USA, Lincoln, Rhode Island
  • CNTF Study Group
    Ophthalmology, Duke University Eye Center, Durham, North Carolina
  • Footnotes
    Commercial Relationships  Glenn J. Jaffe, Alcon (C), Neurotech (C); Jaque L. Duncan, None; Weng Tao, Neurotech USA (E)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science April 2011, Vol.52, 1651. doi:
  • Views
  • Share
  • Tools
    • Alerts
      ×
      This feature is available to authenticated users only.
      Sign In or Create an Account ×
    • Get Citation

      Glenn J. Jaffe, Jaque L. Duncan, Weng Tao, CNTF Study Group; A Phase 2 Study of Encapsulated CNTF-Secreting Cell Implant (NT-501) In Patients with Geographic Atrophy Associated with Dry AMD. Invest. Ophthalmol. Vis. Sci. 2011;52(14):1651.

      Download citation file:


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

      ×
  • Supplements
Abstract
 
Purpose:
 

To report the 18-month Phase 2 study results of an encapsulated CNTF-secreting cell implant in eyes with geographic atrophy associated with dry AMD.

 
Methods:
 

The CNTF study consists of 48 participants that were randomized in a 2:1:1 ratio to receive an intravitreal high or low CNTF output implant, or to sham surgery, respectively. BCVA was measured by an Electronic Visual Acuity Tester (EVA) using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol, retinal thickness was measured by time domain optical coherence tomography (OCT) and lesion size was measured by fundus photography, each at 4, 6, 12, and 18 months following implant placement. CNTF concentration, released from explanted implants and in vitreous samples, was measured by ELISA.

 
Results:
 

Visual function was stabilized, as measured by 15-letter loss, in the high dose-treated group compared to sham and low dose groups at 12 and 18 months among eyes with baseline BCVA 20/63 or better. The mean BCVA in the high dose group was 10.5 and 10.0 letters greater than the low dose/sham group at 12 months and 18 months respectively, a difference that was statistically significant at 12 months (p=0.03). Stabilized visual acuity was accompanied by corresponding structural changes; there was a dose-dependent increase in retinal thickness as early as 4 months post-implant and this increase was maintained through 6, 12 and 18 months (p<0.001). The observed retinal thickness increase was predominately located in the outer nuclear layer. GA lesion area growth rate was reduced in treated groups at 12 and 18 months. Both the NT-501 implant and the implant procedure were well tolerated; no serious adverse events associated with the implant or implantation procedure were reported. The explanted devices showed healthy cells and stable CNTF output up to 12 months.

 
Conclusions:
 

Intraocular CNTF delivered by ECT produced long-term stabilized visual acuity and increased retinal thickness without serious adverse events, in eyes with geographic atrophy associated with non-neovascular AMD. These data support next stage clinical studies in a larger patient population.

 
Clinical Trial:
 

http://www.clinicaltrials.gov NCT00447954

 
Keywords: age-related macular degeneration 
×
×

This PDF is available to Subscribers Only

Sign in or purchase a subscription to access this content. ×

You must be signed into an individual account to use this feature.

×