CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 76 enrolled
Drug / intervention
2.0 mg DE-122 Injectable Solution + Lucentis +2 moredrug
Likely dose
2.0 mg DE-122 Injectable Solution + Lucentisfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03211234
NCT03211234Phase 2Completed
CompareCT.gov

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

Santen Inc.·interventional·Posted Jul 7, 2017·Updated Jul 13, 2021

In Brief

A Phase 2 clinical trial evaluating 2.0 mg DE-122 Injectable Solution + Lucentis, 4.0 mg DE-122 Injectable Solution + Lucentis, and 1 other intervention for Age-Related Macular Degeneration. Completed, enrolled 76 participants across 14 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAge-Related Macular Degeneration
CountriesPhilippines, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJul 7, 2017
Enrollment StartJul 5, 2017
Primary CompletionDec 31, 2019
Study CompletionJan 31, 2020
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 9.0 years ago

Interventions

2.0 mg DE-122 Injectable Solution + Lucentisdrug

Subjects will receive 6 monthly intravitreal injections of low dose DE-122 in the study eye, in combination with Lucentis.

4.0 mg DE-122 Injectable Solution + Lucentisdrug

Subjects will receive 6 monthly intravitreal injections of high dose DE-122 in the study eye, in combination with Lucentis.

Lucentisdrug

Subjects will receive 6 monthly intravitreal injections of Sham in the study eye, in combination with Lucentis.