Safety and Tolerability Study for Age-Related Macular Degeneration
|ClinicalTrials.gov Identifier: NCT01485588|
Recruitment Status : Completed
First Posted : December 5, 2011
Last Update Posted : February 24, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Neovascular Age-Related Macular Degeneration||Drug: hI-con1™||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Study Start Date :||December 2010|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||March 2012|
Phase 1- This is a dose escalation study (20µl, 50µl, or 100 µl)given at baseline and then the subject is followed up to week 24.
Phase 1: 20µl, 50µl, or 100µl per injection (in the eye) on Day 1 only
- Safety and Tolerability [ Time Frame: 24 Weeks ]Phase 1 is designed to evaluate the safety and tolerability of single ascending doses of hI-con1 and to determine the MTD that can be administered by intravitreal injection. Assessments that will be conducted are OCTs, FAs, Blood Pressure, Color Fundus, VA Acutiy, Labs, Ophthalmic exams, and IOPs. They will be occurring at screening through week 24.
- Safety [ Time Frame: 24 weeks ]Phase 2 is designed to evaluate the safety of 3 injections of hI-con1 using the MTD and one dosage level lower than the MTD or standard of care Lucentis administered by intravitreal injection. Assessments that will be conducted are OCTs, FAs, Blood Pressure, Color Fundus, VA Acutiy, Labs, Ophthalmic exams, and IOPs. They will be occurring at screening through week 24.
- Efficacy [ Time Frame: 24 Weeks ]For both Phase 1 and Phase 2, preliminary efficacy will be assessed by change from baseline in visual acuity, fluorescein leakage, retinal thickness and fibrosis, if detectable, based on fundus examination, fundus photography, fluorescein angiography and OCT.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01485588
|United States, Montana|
|Rocky Mountain Eye Center, P.C.|
|Missoula, Montana, United States, 59801|
|United States, Oregon|
|Retina & Vitreous Center of Southern Oregon, P.C.|
|Ashland, Oregon, United States, 97520|
|United States, South Carolina|
|Palmetto Retina Center|
|West Columbia, South Carolina, United States, 29169|
|United States, Texas|
|Retina Research Center|
|Austin, Texas, United States, 78705|
|Valley Retina Institute, PA|
|McAllen, Texas, United States, 78503|