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.

Study Overview

• Status: Completed
• Conditions: Glaucoma, Primary Open Angle
• Intervention / Treatment: Drug: NT-501 CNTF Implant

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Bascom Palmer Eye Institute, University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NT-501 CNTF Implant; Patients will receive single NT-501 CNTF implant in one eye.	Drug: NT-501 CNTF Implant; Single implantation of CNTF-secreting NT-501 device into one eye

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety: Number of adverse events	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.	18 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Functional Efficacy: Vision, Visual Field, Pattern Electroretinogram; Visual Field Questionnaire-25	18 months
Structural Efficacy: Nerve fiber layer, optic nerve topography	18 months

Collaborators and Investigators

• Sponsor: Jeffrey L Goldberg
• Investigators: Principal Investigator: Jeffrey L Goldberg, MD, PhD, Bascom Palmer Eye Institute, University of Miami

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: August 2, 2011
• First Submitted That Met QC Criteria: August 2, 2011
• First Posted (Estimate): August 3, 2011

Study Record Updates

• Last Update Posted (Estimate): August 2, 2016
• Last Update Submitted That Met QC Criteria: August 1, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: 20090257