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NCT04499248 · ClinicalTrials.gov registry record · Phase 1
AGN-193408 SR in the Treatment of Open-angle Glaucoma or Ocular Hypertension
A Phase 1 study of Ocular Hypertension and Open Angle Glaucoma, sponsored by AbbVie.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 96
- Enrollment target
- 20
- Study locations
NCT04499248: Recruiting Phase 1 study of Ocular Hypertension and Open Angle Glaucoma, sponsored by AbbVie.
NCT04499248 is a Phase 1 study of Ocular Hypertension and Open Angle Glaucoma that is actively recruiting participants, run by AbbVie. The registered enrollment target is 96 participants, below the 276-participant average among 54 other Ocular Hypertension trials with a reported enrollment target (65% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04499248, a Phase 1 study of Ocular Hypertension and Open Angle Glaucoma, is actively recruiting participants, sponsored by AbbVie.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 96 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a multicenter, open-label, dose escalation (Cohort 1) to masked, randomized, parallel-groups (Cohort 2) and (Cohort 3) study to evaluate the safety and efficacy of AGN-193408 SR in participants with open-angle glaucoma or ocular hypertension
Primary Outcome
IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
Conditions Studied
Interventions
- DRUG AGN-193408 SR
- OTHER Lumigan
- OTHER Sham Administration
- OTHER Lumigan Vehicle
Study Locations (20)
California
- Global Research Management /ID# 241699 - Glendale
- United Medical Research Institute /ID# 241701 - Inglewood
- Lakeside Vision Center /ID# 241698 - Irvine
- The Eye Research Foundation /ID# 234528 - Newport Beach
- Sacramento Eye Consultants /ID# 241697 - Sacramento
- Premiere Practice Management LLC /ID# 235957 - Torrance
- Wolstan & Goldberg Eye Associates /ID# 241700 - Torrance
Florida
- Brandon Eye Associates - Brandon /ID# 276600 - Brandon
- Nature Coast Clinical Research - Crystal River /ID# 237781 - Crystal River
- Advanced Research, LLC /ID# 276987 - Deerfield Beach
- University of Florida Health Ophthalmology - Jacksonville /ID# 243122 - Jacksonville
- East Florida Eye Institute /ID# 235762 - Stuart
- Logan Ophthalmic Research Inc. /ID# 252087 - Tamarac
Georgia
- Coastal Research Associates /ID# 234649 - Roswell
- Thomas Eye Group PC /ID# 266775 - Sandy Springs
Indiana
- Midwest Medical Advisors Inc /ID# 235845 - Carmel
- Indiana University - Glick Eye Institute /ID# 235887 - Indianapolis
Arizona
- Horizon Eye Specialists & Lasik Center - Sun City /ID# 252153 - Sun City
Connecticut
- Connecticut Eye Consultants P.C. /ID# 235862 - Danbury
Illinois
- University of Illinois Hospital and Health Sciences System /ID# 253630 - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2020-11-16 |
| Est. Completion | 2029-02 |
| Phase | Phase 1 |
What NCT04499248 shows while recruiting
NCT04499248 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, below the 276-participant average among 54 other Ocular Hypertension trials with a reported enrollment target (65% lower).
The record links to 2 conditions, with Ocular Hypertension appearing as the primary indexed condition, and to 4 interventions - of which AGN-193408 SR is the first listed.
NCT04499248 names 20 study sites across 7 states, led by California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT04499248 about?
NCT04499248 is a clinical study titled "AGN-193408 SR in the Treatment of Open-angle Glaucoma or Ocular Hypertension". This is a multicenter, open-label, dose escalation (Cohort 1) to masked, randomized, parallel-groups (Cohort 2) and (Cohort 3) study to evaluate the safety and efficacy of AGN-193408 SR in participants with open-angle glaucoma or ocular hypertension
What is the current status of trial NCT04499248?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 96 participants. The study started on 2020-11-16. Estimated completion is 2029-02.
What conditions does trial NCT04499248 study?
This clinical trial studies the following conditions: Ocular Hypertension, Open Angle Glaucoma.
What interventions are being tested in trial NCT04499248?
The interventions under investigation include: AGN-193408 SR (DRUG), Lumigan (OTHER), Sham Administration (OTHER), Lumigan Vehicle (OTHER).
Who is sponsoring clinical trial NCT04499248?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04499248 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04499248's enrollment target sits among peer trials
96 36th of 54 higher than 19 of 54 other Ocular Hypertension trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ocular Hypertension 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.
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