CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 12 enrolled
Drug / intervention
0.5 mg of DE-122 +3 moredrug
Likely dose
0.5 mg of DE-122from 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/NCT02555306
NCT02555306Phase 2Completed

A Phase I/II, Open-label, Dose-escalating, Sequential-cohort Study Assessing the Safety, Tolerability, Immunogenicity, and Bioactivity of a Single Intravitreal Injection of DE-122 Injectable Solution for the Treatment of Refractory Exudative Age-related Macular Degeneration

Santen Inc.·interventional·Posted Sep 21, 2015·Updated Jan 14, 2020

In Brief

A Phase 2 clinical trial evaluating 0.5 mg of DE-122, 1.0 mg of DE-122, and 2 other interventions for Age-Related Macular Degeneration. Completed, enrolled 12 participants across 5 sites.

Detailed Summary

The purpose of the study is to evaluate the safety, tolerability, immunogenicity, and bioactivity of a single intravitreal (IVT) administration of DE-122 in subjects with refractory exudative age-related macular degeneration (AMD).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 21, 2015
Enrollment StartSep 16, 2015
Primary CompletionAug 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 10.8 years ago

Interventions

0.5 mg of DE-122drug

DE-122 Injectable Solution

1.0 mg of DE-122drug

DE-122 Injectable Solution

2.0 mg of DE-122drug

DE-122 Injectable Solution

4.0 mg of DE-122drug

DE-122 Injectable Solution