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

Phase 1

Completed

• Conditions: Glaucoma, Primary Open Angle
• Interventions: Drug: NT-501 CNTF Implant

• Registration Number: NCT01408472
• Lead Sponsor: Jeffrey L Goldberg

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-08-02
• Study First Submitted QC: 2011-08-02
• Study First Posted: 2011-08-03
• Primary Completion: 2013-12
• Study Completion: 2014-10
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-01
• Last Update Posted: 2016-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NT-501 CNTF Implant	NT-501 CNTF Implant	Patients will receive single NT-501 CNTF implant in one eye.

Primary Outcome Measures

Name	Time	Method
Safety: Number of adverse events	18 months	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Bascom Palmer Eye Institute, University of Miami; 🇺🇸 Miami, Florida, United States