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NCT01397409 · ClinicalTrials.gov registry record · Phase 2
Evaluation of AGN-150998 in Exudative Age-related Macular Degeneration (AMD)
A Phase 2 study, sponsored by Allergan.
- Completed
- Registry status
- Phase 2
- Development phase
- 271
- Enrollment target
NCT01397409: Completed Phase 2 study, sponsored by Allergan.
NCT01397409 is a Phase 2 study that has completed, run by Allergan. The registered enrollment target is 271 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (104% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01397409, a Phase 2 study, has completed, sponsored by Allergan.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 271 participants
- Enrollment target
Study Summary
This study is conducted in 3 stages. Stage 1 is an open-label, dose-escalation assessment of the safety of AGN-150998 administered as a single intravitreal injection to patients with advanced exudative Age-related Macular Degeneration (AMD). Stage 2 and Stage 3 are randomized, double-masked, comparisons of the safety and treatment effects on retinal edema and best-corrected visual acuity (BCVA) of AGN-150998 and ranibizumab in treatment-naive patients with exudative AMD. Study medication is administered as needed in Stage 2 and with a fixed-dosing schedule in Stage 3. The study objectives are (1) to identify the highest tolerated dose of AGN-150998, (2) to assess the safety and duration of treatment effects on retinal edema and BCVA, and (3) to characterize the systemic pharmacokinetic profile of AGN-150998.
Primary Outcome
Stage 1 evaluated the safety of a single intravitreal injection of AGN-150998 with doses ranging from 1.0 to 4.2 mg.
Interventions
- OTHER Sham Injection
- DRUG ranibizumab
- DRUG AGN-150998
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 271 participants |
| Start Date | 2011-09-01 |
| Est. Completion | 2014-04-30 |
| Phase | Phase 2 |
What the finished NCT01397409 record still lists
NCT01397409 is an interventional study that assigns participants to a tested intervention. The registered 271 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (104% higher).
The record links to 0 conditions, and to 3 interventions - of which Sham Injection is the first listed.
NCT01397409 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01397409 about?
NCT01397409 is a clinical study titled "Evaluation of AGN-150998 in Exudative Age-related Macular Degeneration (AMD)". This study is conducted in 3 stages. Stage 1 is an open-label, dose-escalation assessment of the safety of AGN-150998 administered as a single intravitreal injection to patients with advanced exudative Age-related Macular Degeneration (AMD). Stage 2 and Stage 3 are randomized, double-masked, compari...
What is the current status of trial NCT01397409?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 271 participants. The study started on 2011-09-01. Estimated completion is 2014-04-30.
What interventions are being tested in trial NCT01397409?
The interventions under investigation include: Sham Injection (OTHER), ranibizumab (DRUG), AGN-150998 (DRUG).
Who is sponsoring clinical trial NCT01397409?
This trial is sponsored by Allergan, which has 314 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01397409's enrollment target sits among peer trials
271 205th of 2000 higher than 1,796 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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