Phase 2
Completed N=10
20089 TA+Lucentis Combo Intravitreal Injections for Treatment of Neovascular Age-related Macular Degeneration (AMD)
Age-Related Macular Degeneration · Choroidal Neovascularization
Source: ClinicalTrials.gov NCT01175395 ↗
Enrolled (actual)
10
Serious AEs
10.0%
Results posted
Oct 2014
Primary outcomePrimary: To Assess the Safety & Tolerability of 20089 TA (6.9 mg or 13.8 mg) When Used Adjunctively With Lucentis 0.5 mg in Subjects With Sub-foveal Neovascular AMD — 0 Number-participants with adverse events
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY To Assess the Safety & Tolerability of 20089 TA (6.9 mg or 13.8 mg) When Used Adjunctively With Lucentis 0.5 mg in Subjects With Sub-foveal Neovascular AMD |
— | — |
| SECONDARY To Determine the Number of Retreatments With Lucentis in Eyes Initially Treated With 20089 TA and Lucentis |
2 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01175395). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.