20089 TA+Lucentis Combo Intravitreal Injections for Treatment of Neovascular Age-related Macular Degeneration (AMD)
Completed · Phase 1/Phase 2
Conditions studied: Age-Related Macular Degeneration, Choroidal Neovascularization
In brief
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-foveal neovascular AMD.
Key facts
- Study ID
- NCT01175395
- Run by
- University of Illinois at Chicago
- People needed
- 10
- Starts
- 2010-09-01
- Expected to finish
- 2013-01-01
- Last updated by the study team
- 2014-10-20
Who can join
Age: 55 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- UIC Eye and Ear Infirmary — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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