NCT03533244

A Study of the Response to AG-86893 in Patients With Pterygium Hyperemia

A Multicenter, Prospective, Randomized, Double-Masked, Phase 2 Study Evaluating the Safety, Tolerability, and Efficacy of Topical AG-86893 in Patients With Pterygium

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Allgenesis Biotherapeutics Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A pterygium is a wing-shaped, benign tissue growth which forms on the surface of the conjunctiva and grows towards the cornea. It can eventually lead to vision impairment. The precise cause of pterygium formation is unknown but new blood vessel growth and fibroblastic structures are characteristics of the disease. AG-86893 is an eye drop being developed to treat hyperemia (redness) and growth of the pterygium. Hypothesis 1. AG-86893 dosed three times daily for 28 consecutive days has an acceptable safety profile as measured by the incidence and severity of adverse events (AEs) compared with vehicle 2. At least 1 concentration of AG-86893 is effective, as measured by the mean change from baseline in conjunctival hyperemia (redness), compared with vehicle

Conditions

• Pterygium

Interventions

Type	Name	Description
DRUG	0.1% AG-86893 Eye Drops	One drop, three times daily to the study eye for 28 days
DRUG	0.3% AG-86893 Eye Drops	One drop, three times daily to the study eye for 28 days
DRUG	Vehicle Eye Drops	One drop, three times daily to the study eye for 28 days

Timeline

• Start date: 2018-10-11
• Primary completion: 2019-09-05
• Completion: 2019-10-25
• First posted: 2018-05-23
• Last updated: 2020-11-06
• Results posted: 2020-11-06

Locations

6 sites across 1 country: Australia

Regulatory

• FDA-regulated drug study