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

Glaucoma, Primary Open Angle Clinical Trial

Official title:

CNTF Cell Implants For Glaucoma: A Phase I Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01408472
• Other study ID #: 20090257
• Status: Completed
• Phase: Phase 1
• First received: August 2, 2011
• Last updated: August 1, 2016
• Start date: April 2011
• Est. completion date: October 2014

Study information

• Verified date: August 2016
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: October 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Glaucoma, Primary Open Angle

Intervention

Drug:
• NT-501 CNTF Implant
Single implantation of CNTF-secreting NT-501 device into one eye

Locations

Country	Name	City	State
United States	Bascom Palmer Eye Institute, University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Jeffrey L Goldberg

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Functional Efficacy: Vision, Visual Field, Pattern Electroretinogram; Visual Field Questionnaire-25		18 months	Yes
Secondary	Structural Efficacy: Nerve fiber layer, optic nerve topography		18 months	Yes