NCT03211234

Study Assessing the Efficacy and Safety of Intravitreal Injections of DE-122 in Combination With Lucentis® Compared to Lucentis® Monotherapy in Wet Age-related Macular Degeneration Subjects

A Multi-Center, Randomized, Double Masked and Active Controlled Phase II Study Assessing the Efficacy and Safety of Intravitreal Injections of DE-122 in Combination With Lucentis® Compared to Lucentis® Monotherapy in Subjects With Wet Age-related Macular Degeneration - AVANTE Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Santen Inc. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

To assess the safety and efficacy of repeated intravitreal injections of DE-122 (low dose and high dose) given in combination with Lucentis® in subjects with wet age-related macular degeneration (AMD) compared with Lucentis® alone.

Conditions

• Age-Related Macular Degeneration

Interventions

Type	Name	Description
DRUG	2.0 mg DE-122 Injectable Solution + Lucentis	Subjects will receive 6 monthly intravitreal injections of low dose DE-122 in the study eye, in combination with Lucentis.
DRUG	4.0 mg DE-122 Injectable Solution + Lucentis	Subjects will receive 6 monthly intravitreal injections of high dose DE-122 in the study eye, in combination with Lucentis.
DRUG	Lucentis	Subjects will receive 6 monthly intravitreal injections of Sham in the study eye, in combination with Lucentis.

Timeline

• Start date: 2017-07-05
• Primary completion: 2019-12-31
• Completion: 2020-01-31
• First posted: 2017-07-07
• Last updated: 2021-07-13
• Results posted: 2021-07-13

Locations

14 sites across 2 countries: United States, Philippines

Regulatory

• FDA-regulated drug study