Status:
COMPLETED
20089 TA+Lucentis Combo Intravitreal Injections for Treatment of Neovascular Age-related Macular Degeneration (AMD)
Lead Sponsor:
University of Illinois at Chicago
Collaborating Sponsors:
ICON Bioscience Inc
Conditions:
Age-Related Macular Degeneration
Choroidal Neovascularization
Eligibility:
All Genders
55+ years
Phase:
PHASE1
PHASE2
Brief Summary
The primary purpose of this study is to assess the safety \& tolerability of an investigational drug 20089 TA (6.9 mg or 13.8 mg) when used adjunctively with Lucentis 0.5 mg in subjects with sub-fovea...
Detailed Description
The study is being done to test the safety and effectiveness of an investigational drug 20089 TA that will be used in combination with Lucentis for the treatment of CNVM. In CNVM, tiny abnormal blood ...
Eligibility Criteria
Inclusion
- Male or Female subjects, 55 years of age and older.
- Diagnosis of active, subfoveal choroidal neovascular membranes (CNVM) due to age related macular degeneration (AMD)
- Visual acuity from 20/25 to 20/400 in the study eye.
Exclusion
- Subjects who have received corticosteroids via any route in the past 30 days.
- In the opinion of the investigator, patient is known to be a steroid-responder.
- Subjects with a history of uncontrolled glaucoma (Primary or Secondary)
- History of ocular surgery (invasive or non-invasive) in the past 90 days
- Intravitreal treatment with an anti-VEGF agent e.g. bevacizumab, ranibizumab, or pegaptanib within 30 days of the enrollment (Day 0) examination.
- Patients requiring systemic steroids (greater than 15 mg daily by mouth) or systemic immunomodulatory agents.
- Active ocular or periocular infection (i.e., bacterial, viral, parasitic or fungal) in either eye or a history of herpetic ocular infection in either eye.
- Media opacity in the study eye precluding observation or photography of the fundus.
- Any other clinically significant medical or psychological condition that, in the opinion of the Investigator, would jeopardize the safety of the patient or affect the validity of the study results.
- Participation in a clinical trial of an investigational drug or device within 30 days of the screening visit.
- Known history of allergy to corticosteroids.
- Pregnant or lactating women
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01175395
Start Date
September 1 2010
End Date
January 1 2013
Last Update
October 20 2014
Active Locations (1)
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1
UIC Eye and Ear Infirmary
Chicago, Illinois, United States, 60612