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NT-501 CNTF Implant for Glaucoma: Safety, Neuroprotection and Neuroenhancement

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: NCT01408472
Recruitment Status : Completed
First Posted : August 3, 2011
Last Update Posted : August 2, 2016
Sponsor:
Information provided by (Responsible Party):
Jeffrey L Goldberg, Stanford University

Tracking Information
First Submitted Date  ICMJE August 2, 2011
First Posted Date  ICMJE August 3, 2011
Last Update Posted Date August 2, 2016
Study Start Date  ICMJE April 2011
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 8, 2011)
Safety: Number of adverse events [ Time Frame: 18 months ]
Safety will be evaluated by counting the number of patients with adverse events, including loss of vision, visual field, or retinal/optic nerve structure, and ocular complications such as pain and inflammation.
Original Primary Outcome Measures  ICMJE
 (submitted: August 2, 2011)
Safety [ Time Frame: 18 months ]
Safety will be evaluated by loss of vision, visual field, or retinal/optic nerve structure, and by ocular complications such as pain and inflammation.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 4, 2011)
  • Functional Efficacy: Vision, Visual Field, Pattern Electroretinogram; Visual Field Questionnaire-25 [ Time Frame: 18 months ]
  • Structural Efficacy: Nerve fiber layer, optic nerve topography [ Time Frame: 18 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 2, 2011)
  • Functional Efficacy: Vision, Visual Field, Pattern Electroretinogram; VFQ-25 [ Time Frame: 18 months ]
  • Structural Efficacy: Nerve fiber layer, optic nerve topography [ Time Frame: 18 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE NT-501 CNTF Implant for Glaucoma: Safety, Neuroprotection and Neuroenhancement
Official Title  ICMJE CNTF Cell Implants For Glaucoma: A Phase I Study
Brief Summary Ciliary Neurotrophic Factor (CNTF) has been demonstrated in multiple pre-clinical models to enhance survival and regeneration of retinal ganglion cells, the retinal neurons injured in diseases like glaucoma. We hypothesize that CNTF delivery to the human eye will provide neuroprotection (prevent loss of vision) and neuroenhancement (improve vision indices) in glaucoma. Patients in the trial will receive an NT-501 CNTF implant (made by Neurotech) into one eye, and will be carefully followed to evaluate safety and efficacy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Glaucoma, Primary Open Angle
Intervention  ICMJE Drug: NT-501 CNTF Implant
Single implantation of CNTF-secreting NT-501 device into one eye
Study Arms  ICMJE Experimental: NT-501 CNTF Implant
Patients will receive single NT-501 CNTF implant in one eye.
Intervention: Drug: NT-501 CNTF Implant
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 26, 2013)
11
Original Estimated Enrollment  ICMJE
 (submitted: August 2, 2011)
10
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • must understand and sign the informed consent
  • must be medically able to undergo ophthalmic surgery for the NT-501 device insertion and possible removal, as well as the testing required.
  • diagnosis of glaucoma characterized by (a) clinical evidence of progressive RGC dysfunction and degeneration using both visual field and at least one structural modality; (b) residual visual field preservation including best-corrected visual acuity (BCVA) better than 20/100; (c) failure to contain glaucomatous progression with maximally tolerated reduction of intraocular pressure (IOP), OR visual field defect affecting fixation, but not reducing BCVA below 20/100.

Exclusion Criteria:

  • other corneal, lens, optic nerve or retinal disease causing vision loss,
  • blind in one eye
  • requirement of acyclovir and/or related products during study
  • receiving systemic steroids or other immunosuppressive medications.
  • pregnant or lactating.
  • considered immunodeficient or has a known history of human immunodeficiency virus (HIV)
  • on chemotherapy, or a history of malignancy, UNLESS it was treated successfully 2 years prior to inclusion in the trial.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01408472
Other Study ID Numbers  ICMJE 20090257
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jeffrey L Goldberg, Stanford University
Study Sponsor  ICMJE Jeffrey L Goldberg
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jeffrey L Goldberg, MD, PhD Bascom Palmer Eye Institute, University of Miami
PRS Account Stanford University
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP