NT-501 CNTF Implant for Glaucoma: Safety, Neuroprotection and Neuroenhancement
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Jeffrey L. Goldberg, University of Miami
First received: August 2, 2011
Last updated: May 26, 2013
Last verified: May 2013
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.
Glaucoma, Primary Open Angle
Drug: NT-501 CNTF Implant
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||CNTF Cell Implants For Glaucoma: A Phase I Study
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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 ]
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2013 (Final data collection date for primary outcome measure)
Experimental: NT-501 CNTF Implant
Patients will receive single NT-501 CNTF implant in one eye.
Drug: NT-501 CNTF Implant
Single implantation of CNTF-secreting NT-501 device into one eye
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01408472
|Bascom Palmer Eye Institute, University of Miami
|Miami, Florida, United States, 33136 |
Jeffrey L. Goldberg
||Jeffrey L Goldberg, MD, PhD
||Bascom Palmer Eye Institute, University of Miami
No publications provided
||Jeffrey L. Goldberg, Associate Professor of Ophthalmology, University of Miami
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 2, 2011
||May 26, 2013
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 20, 2014