NT-501 CNTF Implant for Ischemic Optic Neuropathy: Safety, Neuroprotection and Neuroenhancement

NCT01411657 | Completed Phase 1 DMC

• 1 other identifier: 20090300
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

Ciliary Neurotrophic Factor (CNTF) has been demonstrated in multiple preclinical models to enhance survival and regeneration of retinal ganglion cells, the retinal neurons injured in diseases like ischemic optic neuropathy/optic nerve stroke. We hypothesize that CNTF delivery to the human eye will provide neuroprotection (prevent loss of vision) and neuroenhancement (improve vision indices) in ischemic optic neuropathy. 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.

Conditions

Ischemic Optic Neuropathy/Optic Nerve Stroke

Outcome Measures

Primary Outcomes (1)

• Safety: Number of patients with adverse events

  Safety will be evaluated by determining 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 Outcomes (2)

• Functional Efficacy: Vision, Visual Field, Pattern Electroretinogram, Visual Field Questionnaire-25

  18 months

• Structural efficacy: Nerve fiber layer, optic nerve topography

  18 months

Study Arms (1)

NT-501 CNTF Implant

EXPERIMENTAL

Patients will receive single NT-501 CNTF implant in one eye

Drug: NT-501 CNTF Implant

Interventions

NT-501 CNTF Implant DRUG

Single implantation of CNTF-secreting NT-501 device into one eye

NT-501 CNTF Implant

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 40 years or older
• 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 ischemic optic neuropathy characterized by (a) non-arteritic subtype, including a normal ESR and CRP; (b) syndrome of acute unilateral visual loss with documented optic nerve head edema but without significant pain; (c) a relative afferent papillary defect in the affected eye, and a decrease of best-corrected visual acuity to 20/40 or worse in the affected eye, and detectable loss on visual field testing consistent with nerve fiber visual field defect but retaining measurable residual visual field preservation.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Jeffrey L Goldberg: lead

Study Sites (1)

Bascom Palmer Eye Institute, University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Optic Neuropathy, Ischemic

Condition Hierarchy (Ancestors)

Optic Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Ophthalmology

Study Record Dates

• First Submitted: August 5, 2011
• First Posted: August 8, 2011
• Study Start: April 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: October 1, 2014
• Last Updated: August 2, 2016

Record last verified: 2016-08

Locations

US (1)