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NCT02555306 · ClinicalTrials.gov registry record · Phase 1
A Phase I/II Safety, Tolerability, Immunogenicity, and Bioactivity Study of DE-122 Injectable Solution for Refractory Exudative Age-related Macular Degeneration
A Phase 1 study, sponsored by Santen.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT02555306: Completed Phase 1 study, sponsored by Santen.
NCT02555306 is a Phase 1 study that has completed, run by Santen. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02555306, a Phase 1 study, has completed, sponsored by Santen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
The purpose of the study is to evaluate the safety, tolerability, immunogenicity, and bioactivity of a single intravitreal (IVT) administration of DE-122 in subjects with refractory exudative age-related macular degeneration (AMD).
Primary Outcome
BCVA measures the acuteness or clearness of best-corrected vision in ETDRS (Early Treatment of Diabetic Retinopathy Study) letters, with a range of \[0, 97\] in ETDRS letters. An increase in BCVA indicates an improvement in the best corrected vision.
Interventions
- DRUG 0.5 mg of DE-122
- DRUG 1.0 mg of DE-122
- DRUG 2.0 mg of DE-122
- DRUG 4.0 mg of DE-122
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2015-09-16 |
| Est. Completion | 2017-08 |
| Phase | Phase 1 |
What the finished NCT02555306 record still lists
NCT02555306 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 4 interventions - of which 0.5 mg of DE-122 is the first listed.
NCT02555306 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02555306 about?
NCT02555306 is a clinical study titled "A Phase I/II Safety, Tolerability, Immunogenicity, and Bioactivity Study of DE-122 Injectable Solution for Refractory Exudative Age-related Macular Degeneration". The purpose of the study is to evaluate the safety, tolerability, immunogenicity, and bioactivity of a single intravitreal (IVT) administration of DE-122 in subjects with refractory exudative age-related macular degeneration (AMD).
What is the current status of trial NCT02555306?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2015-09-16. Estimated completion is 2017-08.
What interventions are being tested in trial NCT02555306?
The interventions under investigation include: 0.5 mg of DE-122 (DRUG), 1.0 mg of DE-122 (DRUG), 2.0 mg of DE-122 (DRUG), 4.0 mg of DE-122 (DRUG).
Who is sponsoring clinical trial NCT02555306?
This trial is sponsored by Santen, which has 32 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02555306's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 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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