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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jeffrey L. Goldberg, University of Miami
ClinicalTrials.gov Identifier:
NCT01408472
First received: August 2, 2011
Last updated: May 26, 2013
Last verified: May 2013

August 2, 2011
May 26, 2013
April 2011
December 2013   (final data collection date for primary outcome measure)
Safety: Number of adverse events [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
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.
Safety [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
Safety will be evaluated by loss of vision, visual field, or retinal/optic nerve structure, and by ocular complications such as pain and inflammation.
Complete list of historical versions of study NCT01408472 on ClinicalTrials.gov Archive Site
  • Functional Efficacy: Vision, Visual Field, Pattern Electroretinogram; Visual Field Questionnaire-25 [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • Structural Efficacy: Nerve fiber layer, optic nerve topography [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • Functional Efficacy: Vision, Visual Field, Pattern Electroretinogram; VFQ-25 [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • Structural Efficacy: Nerve fiber layer, optic nerve topography [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
NT-501 CNTF Implant for Glaucoma: Safety, Neuroprotection and Neuroenhancement
CNTF Cell Implants For Glaucoma: A Phase I Study

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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Glaucoma, Primary Open Angle
Drug: NT-501 CNTF Implant
Single implantation of CNTF-secreting NT-501 device into one eye
Experimental: NT-501 CNTF Implant
Patients will receive single NT-501 CNTF implant in one eye.
Intervention: Drug: NT-501 CNTF Implant
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
11
December 2013
December 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01408472
20090257
Yes
Jeffrey L. Goldberg, University of Miami
Jeffrey L. Goldberg
Not Provided
Principal Investigator: Jeffrey L Goldberg, MD, PhD Bascom Palmer Eye Institute, University of Miami
University of Miami
May 2013

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