20089 TA+Lucentis Combo Intravitreal Injections for Treatment of Neovascular Age-related Macular Degeneration (AMD)

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

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-foveal neovascular AMD.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Illinois at Chicago
• Collaborator: ICON Bioscience Inc
• Treatments: Ranibizumab; Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

Criteria

Inclusion Criteria:

1. Male or Female subjects, 55 years of age and older.

2. Diagnosis of active, subfoveal choroidal neovascular membranes (CNVM) due to age related macular degeneration (AMD)

3. Visual acuity from 20/25 to 20/400 in the study eye.

Exclusion Criteria:

1. Subjects who have received corticosteroids via any route in the past 30 days.

2. In the opinion of the investigator, patient is known to be a steroid-responder.

3. Subjects with a history of uncontrolled glaucoma (Primary or Secondary)

4. History of ocular surgery (invasive or non-invasive) in the past 90 days

5. Intravitreal treatment with an anti-VEGF agent e.g. bevacizumab, ranibizumab, or pegaptanib within 30 days of the enrollment (Day 0) examination.

6. Patients requiring systemic steroids (greater than 15 mg daily by mouth) or systemic immunomodulatory agents.

7. 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.

8. Media opacity in the study eye precluding observation or photography of the fundus.

9. 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.

10. Participation in a clinical trial of an investigational drug or device within 30 days of the screening visit.

11. Known history of allergy to corticosteroids.

12. Pregnant or lactating women