NCT01485588

Safety and Tolerability Study for Age-Related Macular Degeneration

A Phase 1 / 2 Trial to Investigate The Safety and Tolerability of Single and Repeated Doses of hI-CON1™ Following Administration by Intravitreal Injection in Subjects With Neovascular Age-Related Macular Degeneration (AMD)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Iconic Therapeutics, Inc. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

Phase 1: The purpose of this study is to evaluate the safety and tolerability of single ascending doses of hI-con1™ for subjects with Age-Related Macular Degeneration. Phase 2: The purpose of this study is to evaluate the safety of 3 injections of hI-con1™ at 2 different dose levels.

Conditions

• Neovascular Age-Related Macular Degeneration

Interventions

Type	Name	Description
DRUG	hI-con1™ 60µl	Phase 1: 60µl, 150µl, or 300µl per injection (in the eye) on Day 1 only
DRUG	hI-con1™ 150µl	Phase 1: 60µl, 150µl, or 300µl per injection (in the eye) on Day 1 only
DRUG	hI-con1™ 300µl	Phase 1: 60µl, 150µl, or 300µl per injection (in the eye) on Day 1 only

Timeline

• Start date: 2010-12-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2011-12-05
• Last updated: 2020-11-06
• Results posted: 2020-11-06

Locations

5 sites across 1 country: United States