This trial is active, not recruiting.

Condition glaucoma, primary open angle
Treatment nt-501 cntf implant
Phase phase 1
Sponsor Jeffrey L. Goldberg
Start date April 2011
End date December 2013
Trial size 11 participants
Trial identifier NCT01408472, 20090257


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Patients will receive single NT-501 CNTF implant in one eye.
nt-501 cntf implant
Single implantation of CNTF-secreting NT-501 device into one eye

Primary Outcomes

Safety: Number of adverse events
time frame: 18 months

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title CNTF Cell Implants For Glaucoma: A Phase I Study
Principal investigator Jeffrey L Goldberg, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in May 2013.
Information provided to ClinicalTrials.gov by University of Miami.