NCT04499248

AGN-193408 SR in the Treatment of Open-angle Glaucoma or Ocular Hypertension

A Phase 1/2 Study to Evaluate the Safety and Efficacy of AGN-193408 SR in Participants With Open-Angle Glaucoma or Ocular Hypertension

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Open-angle Glaucoma
• Ocular Hypertension

Interventions

Type	Name	Description
DRUG	AGN-193408 SR	An implant containing preservative-free AGN-193408 dispersed in a biodegradable polymer matrix. Implants are preloaded into an applicator to facilitate insertion of the implant into the anterior chamber of the study eye.
OTHER	Lumigan	Control Treatment in Fellow Eye Lumigan 0.01% is a topical eye drop that is a solution containing 0.1 mg/mL bimatoprost
OTHER	Sham Administration	Needleless applicator contacting similar intracameral insertion location on eye as AGN-193408 SR.
OTHER	Lumigan Vehicle	Vehicle eye drops (for masking) will be administered once daily in the evening starting on Day 1 in the study eye during Cohort 2.
DRUG	AGN-193408 SR	An implant containing preservative-free AGN-193408 dispersed in a biodegradable polymer matrix. Implants are preloaded into an applicator to facilitate insertion of the implant in the study eye.
OTHER	Sham Administration	Needleless applicator contacting similar insertion location on eye as AGN-193408 SR.
OTHER	Lumigan Vehicle	Vehicle eye drops (for masking) will be administered once daily in the evening starting on Day 1 in the study eye during Cohort 3.

Timeline

• Start date: 2020-11-16
• Primary completion: 2029-02-01
• Completion: 2029-02-01
• First posted: 2020-08-05
• Last updated: 2026-03-23

Locations

49 sites across 2 countries: United States, Japan

Regulatory

• FDA-regulated drug study