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

NCT01408472 | Completed Phase 1 DMC

• 1 other identifier: 20090257
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma, Primary Open Angle

Outcome Measures

Primary Outcomes (1)

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

You may qualify if:

• 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.

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

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Study Officials

• Jeffrey L Goldberg, MD, PhD

  Bascom Palmer Eye Institute, University of Miami

  PRINCIPAL INVESTIGATOR

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 2, 2011
• First Posted: August 3, 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)