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Trial record 1 of 1 for:    IBI-20089
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20089 TA+Lucentis Combo Intravitreal Injections for Treatment of Neovascular Age-related Macular Degeneration (AMD) (20089/Combo)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01175395
Recruitment Status : Completed
First Posted : August 4, 2010
Results First Posted : October 20, 2014
Last Update Posted : October 20, 2014
ICON Bioscience Inc
Information provided by (Responsible Party):
Jennifer I. Lim, University of Illinois at Chicago

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-foveal neovascular AMD.

Condition or disease Intervention/treatment Phase
Age-Related Macular Degeneration Choroidal Neovascularization Drug: IBI-20089/Lucentis Phase 1 Phase 2

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 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2010
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Arm Intervention/treatment
Experimental: IBI-20089/Lucentis
Alternate treatment of either 6.9 mg IBI-20089/Lucentis or 13.8 mg IBI-20089/Lucentis
Drug: 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)

Primary Outcome Measures :
  1. 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 ]

    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.

Secondary Outcome Measures :
  1. To Determine the Number of Retreatments With Lucentis in Eyes Initially Treated With 20089 TA and Lucentis [ Time Frame: 30 to 360 days ]
    Because of the combination - 20089/Lucentis - treatment, patients may not require monthly Lucentis injections as is the current standard of care practice for AMD.

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01175395

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United States, Illinois
UIC Eye and Ear Infirmary
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
University of Illinois at Chicago
ICON Bioscience Inc
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Principal Investigator: Jennifer I Lim, MD University of Illinois at Chicago
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Jennifer I. Lim, Professor of Ophthalmology, Director of Retina Services, Department of Ophthalmology and Visual Sciences, University of Illinois at Chicago Identifier: NCT01175395    
Other Study ID Numbers: 2009-1067
First Posted: August 4, 2010    Key Record Dates
Results First Posted: October 20, 2014
Last Update Posted: October 20, 2014
Last Verified: October 2014
Keywords provided by Jennifer I. Lim, University of Illinois at Chicago:
Choroidal neovascular membranes
Age-relate Macular Degeneration
Additional relevant MeSH terms:
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Macular Degeneration
Choroidal Neovascularization
Neovascularization, Pathologic
Retinal Degeneration
Retinal Diseases
Eye Diseases
Pathologic Processes
Choroid Diseases
Uveal Diseases
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents