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NCT02591914 · ClinicalTrials.gov registry record · Phase 1
An Open-Label Investigator Sponsored Trial to Investigate the Safety, Tolerability and Development of Subfoveal Fibrosis By Intravitreal Administration of Altering Regimens of Fovista and Anti-VEGF Therapy in Subjects With Neovascular Age-Related Macular Degeneration
A Phase 1 study, sponsored by Retinal Consultants of Arizona.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT02591914 is a Phase 1 study that has completed, run by Retinal Consultants of Arizona. The registered enrollment target is 30 participants.
The verdict
NCT02591914, a Phase 1 study, has completed, sponsored by Retinal Consultants of Arizona.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
The objectives of this study are to establish the safety and tolerability of intravitreous administration of altering regimens of Fovista™ (Anti-PDGF-B pegylated aptamer) administered in combination with Anti-VEGF therapy (Lucentis®, Avastin® or Eylea®) in subjects with subfoveal neovascular age-related macular degeneration. Subjects will be treated with Fovista™ and Anti-VEGF therapy every month for the first three months. Retreatment with Fovista™ and Anti-VEGF will occur if the following findings are present PER INVESTIGATOR DISCRETION: * ≥ 5 ETDRS letters loss OR; * Significant hemorrhage OR; * New or increased RPE elevation consistent with increased disease activity OR; * Increased neovascular lesion size OR; * New or increased foveal intraretinal fluid If anti-VEGF re-treatment is not administered based on the re-treatment criteria noted above, Fovista™ anti-PDGF therapy MUST be administered at a minimum of every 3 months (as monotherapy). Therefore, subjects will be treated with Fovista™ or Anti-VEGF therapy for a total of 3-24 administrations.
Interventions
- DRUG Fovista™
- DRUG Lucentis®
- DRUG Avastin®
- DRUG Eylea®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2014-02 |
| Est. Completion | 2016-05-24 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02591914
The ClinicalTrials.gov registry entry for NCT02591914 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Retinal Consultants of Arizona, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Fovista™ is the first listed.
NCT02591914 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02591914 about?
NCT02591914 is a clinical study titled "An Open-Label Investigator Sponsored Trial to Investigate the Safety, Tolerability and Development of Subfoveal Fibrosis By Intravitreal Administration of Altering Regimens of Fovista and Anti-VEGF Therapy in Subjects With Neovascular Age-Related Macular Degeneration". The objectives of this study are to establish the safety and tolerability of intravitreous administration of altering regimens of Fovista™ (Anti-PDGF-B pegylated aptamer) administered in combination with Anti-VEGF therapy (Lucentis®, Avastin® or Eylea®) in subjects with subfoveal neovascular age-rel...
What is the current status of trial NCT02591914?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2014-02. Estimated completion is 2016-05-24.
What interventions are being tested in trial NCT02591914?
The interventions under investigation include: Fovista™ (DRUG), Lucentis® (DRUG), Avastin® (DRUG), Eylea® (DRUG).
Who is sponsoring clinical trial NCT02591914?
This trial is sponsored by Retinal Consultants of Arizona, which has 4 total clinical trials registered on ClinicalTrials.gov.
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