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NCT01213082 · ClinicalTrials.gov registry record · Phase 1
ProspectiveTrial of Proton Beam Combined With Anti-VEGF Therapy for Exudative Age-related Macular Degeneration (AMD)
A Phase 1 study, sponsored by University of California, Davis.
- Completed
- Registry status
- Phase 1
- Development phase
- 34
- Enrollment target
NCT01213082: Completed Phase 1 study, sponsored by University of California, Davis.
NCT01213082 is a Phase 1 study that has completed, run by University of California, Davis. The registered enrollment target is 34 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01213082, a Phase 1 study, has completed, sponsored by University of California, Davis.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 34 participants
- Enrollment target
Study Summary
The purpose of this study is to test the hypothesis that proton beam irradiation combined with intravitreal anti-VEGF therapy is safe and potentially more effective than intravitreal anti-VEGF therapy alone in eyes with exudative age-related macular degeneration.
Primary Outcome
vision loss of 3 or more lines associated with radiation retinopathy or papillopathy
Interventions
- DRUG 24GyE proton and Anti-VEGF
- DRUG 16GyE and anti-VEGF
- DRUG Sham Irradiation and anti-VEGF
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2010-09 |
| Est. Completion | 2017-01-31 |
| Phase | Phase 1 |
What the finished NCT01213082 record still lists
NCT01213082 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 3 interventions - of which 24GyE proton and Anti-VEGF is the first listed.
NCT01213082 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01213082 about?
NCT01213082 is a clinical study titled "ProspectiveTrial of Proton Beam Combined With Anti-VEGF Therapy for Exudative Age-related Macular Degeneration (AMD)". The purpose of this study is to test the hypothesis that proton beam irradiation combined with intravitreal anti-VEGF therapy is safe and potentially more effective than intravitreal anti-VEGF therapy alone in eyes with exudative age-related macular degeneration.
What is the current status of trial NCT01213082?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2010-09. Estimated completion is 2017-01-31.
What interventions are being tested in trial NCT01213082?
The interventions under investigation include: 24GyE proton and Anti-VEGF (DRUG), 16GyE and anti-VEGF (DRUG), Sham Irradiation and anti-VEGF (DRUG).
Who is sponsoring clinical trial NCT01213082?
This trial is sponsored by University of California, Davis, which has 657 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01213082's enrollment target sits among peer trials
34 1273rd of 2000 higher than 721 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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