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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Jeffrey L. Goldberg, University of Miami

ClinicalTrials.gov Identifier:

NCT01408472

First received: August 2, 2011

Last updated: July 26, 2012

Last verified: July 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

August 2, 2011

Last Updated Date

July 26, 2012

Start Date ^ICMJE

June 2011

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Safety: Number of adverse events [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

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.

Original Primary Outcome Measures ^ICMJE

Safety [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Safety will be evaluated by loss of vision, visual field, or retinal/optic nerve structure, and by ocular complications such as pain and inflammation.

Change History

Complete list of historical versions of study NCT01408472 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Functional Efficacy: Vision, Visual Field, Pattern Electroretinogram; Visual Field Questionnaire-25 [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
Structural Efficacy: Nerve fiber layer, optic nerve topography [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Functional Efficacy: Vision, Visual Field, Pattern Electroretinogram; VFQ-25 [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
Structural Efficacy: Nerve fiber layer, optic nerve topography [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

CNTF Cell Implants For Glaucoma: A Phase I Study

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

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

Condition ^ICMJE

Glaucoma, Primary Open Angle

Intervention ^ICMJE

Drug: NT-501 CNTF Implant

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

Study Arm (s)

Experimental: NT-501 CNTF Implant

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

Intervention: Drug: NT-501 CNTF Implant

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2013

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01408472

Other Study ID Numbers ^ICMJE

20090257

Has Data Monitoring Committee

Yes

Responsible Party

Jeffrey L. Goldberg, University of Miami

Study Sponsor ^ICMJE

Jeffrey L. Goldberg

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Jeffrey L Goldberg, MD, PhD

Bascom Palmer Eye Institute, University of Miami

Information Provided By

University of Miami

Verification Date

July 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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