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NCT02859441 · ClinicalTrials.gov registry record · Phase 1
A Phase I/II Trial for Intravitreous Treatment of Severe Ocular Von Hippel-Lindau Disease Using a Combination of the PDGF Antagonist E10030 and the VEGF Antagonist Ranibizumab
A Phase 1 study, sponsored by National Eye Institute (NEI).
- Completed
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT02859441 is a Phase 1 study that has completed, run by National Eye Institute (NEI). The registered enrollment target is 3 participants.
The verdict
NCT02859441, a Phase 1 study, has completed, sponsored by National Eye Institute (NEI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
Background: People with Von-Hippel-Lindau (VHL) disease may experience significant vision loss as a result of retinal capillary hemangiomas (RCH), the most common and often earliest manifestation of VHL. Objective: To investigate the safety and possible efficacy of combination investigational treatment with serial intravitreal injections of E10030, a PDGF-B antagonist, and ranibizumab, a VEGF-A antagonist, in participants with severe ocular VHL disease. Design: Three participants with severe ocular VHL disease will receive the combination investigational treatment in one eye and will be followed for 104 weeks. Primary Outcome: The safety of the combination investigational treatment, assessed by tabulation of adverse events reported through Week 52.
Interventions
- DRUG Ranibizumab
- DRUG E10030
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2017-01-23 |
| Est. Completion | 2019-07-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02859441
The ClinicalTrials.gov registry entry for NCT02859441 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Eye Institute (NEI), which has 221 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Ranibizumab is the first listed.
NCT02859441 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02859441 about?
NCT02859441 is a clinical study titled "A Phase I/II Trial for Intravitreous Treatment of Severe Ocular Von Hippel-Lindau Disease Using a Combination of the PDGF Antagonist E10030 and the VEGF Antagonist Ranibizumab". Background: People with Von-Hippel-Lindau (VHL) disease may experience significant vision loss as a result of retinal capillary hemangiomas (RCH), the most common and often earliest manifestation of VHL. Objective: To investigate the safety and possible efficacy of combination investigational treat...
What is the current status of trial NCT02859441?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2017-01-23. Estimated completion is 2019-07-09.
What interventions are being tested in trial NCT02859441?
The interventions under investigation include: Ranibizumab (DRUG), E10030 (DRUG).
Who is sponsoring clinical trial NCT02859441?
This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.
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