20089 TA+Lucentis Combo Intravitreal Injections for Treatment of Neovascular Age-related Macular Degeneration (AMD) (20089/Combo)
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.
Age-Related Macular Degeneration
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-Label Study of the Safety and Tolerability of Combining 20089 (Triamcinolone Acetonide Intravitreal Injection) When Used Adjunctively With Lucentis® 0.5 mg Intravitreal Injection in Subjects With Subfoveal Neovascular AMD|
- 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 [ Time Frame: 360 Days ] [ Designated as safety issue: Yes ]
The primary objective is to assess the ocular safety of 20089 TA (6.9 mg or 13.8 mg)treatment in combination with Lucentis.
The ocular safety endpoints to be assessed include the number of participants with ocular Adverse Events such as: evidence of endophthalmitis, uveitis, ocular hemorrhage, retinal tear or detachment to be assessed during ophthalmic examinations. Elevated IOP as measured by an applanation tonometer at every visit.
- To Determine the Number of Retreatments With Lucentis in Eyes Initially Treated With 20089 TA and Lucentis [ Time Frame: 30 to 360 days ] [ Designated as safety issue: No ]Because of the combination - 20089/Lucentis - treatment, patients may not require monthly Lucentis injections as is the current standard of care practice for AMD.
|Study Start Date:||September 2010|
|Study Completion Date:||January 2013|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
Alternate treatment of either 6.9 mg IBI-20089/Lucentis or 13.8 mg IBI-20089/Lucentis
Combining a single dose of IBI-20089 (6.9 mg or 13.8 mg) intravitreal injection adjunctively with Lucentis 0.5 mg intravitreal injection at baseline and monthly intravitreal Lucentis injection PRN based on clinical and OCT results.
Other Name: IBI-20089 (Triamcinolone Acetonide)
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 vessels grow through the retinal layers in the eye. These vessels are very fragile and can leak or bleed. The severity of the symptoms depends on the size of the CNVM and its proximity to the macula (the center of visual field). Symptoms may be mild such as a blurry or distorted area of vision, or more severe, like a central blind spot. Although Lucentis has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of CNVM, the study drug 20089 TA has not yet been approved, and therefore is considered an investigational drug.
Triamcinolone Acetonide (TA) is a corticosteroid (an anti-inflammatory drug) that is used to treat many eye diseases, such as: macular edema (where inflammation causes thickening of the macula), diabetic eye disease, and age-related macular degeneration. TA has also been shown to be effective in treating neovascular AMD (also known as "wet AMD") where there is an abnormal growth of blood vessels in the macula.
Study drug 20089 is an experimental form of the corticosteroid, Triamcinolone Acetonide(TA). 20089 is a new slow-release formula (longer lasting) for intravitreal (into the eye) delivery of TA. This drug releases the active agent TA over a period of approximately 6 months thereby allowing for the improvement of inflammation and/or complications following neovascular AMD.
Although intravitreal Lucentis has been shown to prevent the loss of vision in most neovascular AMD patients and help gain visual acuity (how well we can see), results can only be assured if monthly injections are given. Since monthly injections are a burden on the patient and caregiver, attempts are being made to reduce the burden by combining available treatment options. We hope that by combining 20089 TA with Lucentis a decrease in retinal inflammation, closure of the leaky vessels with a decrease in the number of monthly injections could be achieved.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01175395
|United States, Illinois|
|UIC Eye and Ear Infirmary|
|Chicago, Illinois, United States, 60612|
|Principal Investigator:||Jennifer I Lim, MD||University of Illinois at Chicago|