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NCT03211234 · ClinicalTrials.gov registry record · Phase 2
Study Assessing the Efficacy and Safety of Intravitreal Injections of DE-122 in Combination With Lucentis® Compared to Lucentis® Monotherapy in Wet Age-related Macular Degeneration Subjects
A Phase 2 study, sponsored by Santen.
- Completed
- Registry status
- Phase 2
- Development phase
- 76
- Enrollment target
NCT03211234: Completed Phase 2 study, sponsored by Santen.
NCT03211234 is a Phase 2 study that has completed, run by Santen. The registered enrollment target is 76 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03211234, a Phase 2 study, has completed, sponsored by Santen.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 76 participants
- Enrollment target
Study Summary
To assess the safety and efficacy of repeated intravitreal injections of DE-122 (low dose and high dose) given in combination with Lucentis® in subjects with wet age-related macular degeneration (AMD) compared with Lucentis® alone.
Primary Outcome
BCVA is the primary efficacy variable for this study, and mean change from baseline in BCVA at Week 24 is the primary efficacy endpoint. An increase in the number of letters read correctly means that vision has improved.The lower the number of letters read correctly on the eye chart, the worse the vision.
Interventions
- DRUG Lucentis
- DRUG 2.0 mg DE-122 Injectable Solution + Lucentis
- DRUG 4.0 mg DE-122 Injectable Solution + Lucentis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2017-07-05 |
| Est. Completion | 2020-01-31 |
| Phase | Phase 2 |
What the finished NCT03211234 record still lists
NCT03211234 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 3 interventions - of which Lucentis is the first listed.
NCT03211234 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03211234 about?
NCT03211234 is a clinical study titled "Study Assessing the Efficacy and Safety of Intravitreal Injections of DE-122 in Combination With Lucentis® Compared to Lucentis® Monotherapy in Wet Age-related Macular Degeneration Subjects". To assess the safety and efficacy of repeated intravitreal injections of DE-122 (low dose and high dose) given in combination with Lucentis® in subjects with wet age-related macular degeneration (AMD) compared with Lucentis® alone.
What is the current status of trial NCT03211234?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 76 participants. The study started on 2017-07-05. Estimated completion is 2020-01-31.
What interventions are being tested in trial NCT03211234?
The interventions under investigation include: Lucentis (DRUG), 2.0 mg DE-122 Injectable Solution + Lucentis (DRUG), 4.0 mg DE-122 Injectable Solution + Lucentis (DRUG).
Who is sponsoring clinical trial NCT03211234?
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 NCT03211234's enrollment target sits among peer trials
76 893rd of 2000 higher than 1,101 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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