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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 is a Phase 2 study that has completed, run by Allergan. The registered enrollment target is 271 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01397409
The ClinicalTrials.gov registry entry for NCT01397409 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 271 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Allergan, which has 314 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Sham Injection is the first listed.
NCT01397409 reports 0 study locations.
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.
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