NT-501 CNTF Implant for Glaucoma: Safety, Neuroprotection and Neuroenhancement
| Status: | Completed |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/3/2016 |
| Start Date: | April 2011 |
| End Date: | October 2014 |
CNTF Cell Implants For Glaucoma: A Phase I Study
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.
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.
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.
We found this trial at
1
site
Click here to add this to my saved trials
