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

This study has been completed.
Sponsor:
Collaborator:
ICON Bioscience Inc
Information provided by (Responsible Party):
Jennifer I. Lim, University of Illinois at Chicago
ClinicalTrials.gov Identifier:
NCT01175395
First received: August 2, 2010
Last updated: October 13, 2014
Last verified: October 2014
  Purpose

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

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Illinois at Chicago:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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.


Enrollment: 10
Study Start Date: September 2010
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01175395

Locations
United States, Illinois
UIC Eye and Ear Infirmary
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
University of Illinois at Chicago
ICON Bioscience Inc
Investigators
Principal Investigator: Jennifer I Lim, MD University of Illinois at Chicago
  More Information

Additional Information:
No publications provided

Responsible Party: Jennifer I. Lim, Professor of Ophthalmology, Director of Retina Services, Department of Ophthalmology and Visual Sciences, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT01175395     History of Changes
Other Study ID Numbers: 2009-1067
Study First Received: August 2, 2010
Results First Received: May 23, 2013
Last Updated: October 13, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Illinois at Chicago:
Choroidal neovascular membranes
CNV
AMD
Age-relate Macular Degeneration
CNVM
subfoveal

Additional relevant MeSH terms:
Choroidal Neovascularization
Macular Degeneration
Neovascularization, Pathologic
Choroid Diseases
Eye Diseases
Metaplasia
Pathologic Processes
Retinal Degeneration
Retinal Diseases
Uveal Diseases
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Triamcinolone hexacetonide
Anti-Inflammatory Agents
Enzyme Inhibitors
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014