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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: Completed Phase 1 study, sponsored by Retinal Consultants of Arizona.
NCT02591914 is a Phase 1 study that has completed, run by Retinal Consultants of Arizona. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT02591914 record still lists
NCT02591914 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 4 interventions - of which Fovista™ is the first listed.
NCT02591914 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02591914's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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