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NCT01408472 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Glaucoma, Primary Open Angle, sponsored by Jeffrey L Goldberg.

Completed
Registry status
Phase 1
Development phase
11
Enrollment target
1
Study location

NCT01408472: Completed Phase 1 study of Glaucoma, Primary Open Angle, sponsored by Jeffrey L Goldberg.

NCT01408472 is a Phase 1 study of Glaucoma, Primary Open Angle that has completed, run by Jeffrey L Goldberg. The registered enrollment target is 11 participants, below the 68-participant average among 5 other Glaucoma, Primary Open Angle trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01408472, a Phase 1 study of Glaucoma, Primary Open Angle, has completed, sponsored by Jeffrey L Goldberg.

COMPLETED
Registry status
Phase 1
Development phase
11 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

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.

Interventions

  • DRUG NT-501 CNTF Implant

Study Locations (1)

Florida

  • Bascom Palmer Eye Institute, University of Miami - Miami

Trial Details

FieldValue
Enrollment Target 11 participants
Start Date 2011-04
Est. Completion 2014-10
Phase Phase 1
Jeffrey L Goldberg

2 total trials

What the finished NCT01408472 record still lists

NCT01408472 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 68-participant average among 5 other Glaucoma, Primary Open Angle trials with a reported enrollment target (84% lower).

The record links to 1 condition, with Glaucoma, Primary Open Angle appearing as the primary indexed condition, and to 1 intervention - of which NT-501 CNTF Implant is the first listed.

NCT01408472 reports a single indexed study location in Florida.

Frequently Asked Questions

What is clinical trial NCT01408472 about?

NCT01408472 is a clinical study titled "NT-501 CNTF Implant for Glaucoma: Safety, Neuroprotection and Neuroenhancement". 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 los...

What is the current status of trial NCT01408472?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2011-04. Estimated completion is 2014-10.

What conditions does trial NCT01408472 study?

This clinical trial studies the following conditions: Glaucoma, Primary Open Angle.

What interventions are being tested in trial NCT01408472?

The interventions under investigation include: NT-501 CNTF Implant (DRUG).

Who is sponsoring clinical trial NCT01408472?

This trial is sponsored by Jeffrey L Goldberg, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01408472 being conducted?

This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT01408472, the US trial registry maintained by the National Library of Medicine. NCT01408472 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.