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

NCT ID: NCT01175395

Last Updated: 2014-10-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2013-01-31

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.

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.

Conditions

Age-Related Macular Degeneration; Choroidal Neovascularization

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IBI-20089/Lucentis

Alternate treatment of either 6.9 mg IBI-20089/Lucentis or 13.8 mg IBI-20089/Lucentis

Group Type: EXPERIMENTAL

IBI-20089/Lucentis

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

IBI-20089 (Triamcinolone Acetonide)

Eligibility 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

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ICON Bioscience Inc

INDUSTRY

Sponsor Role: collaborator

University of Illinois at Chicago

OTHER

Sponsor Role: lead

Responsible Party

Jennifer I. Lim

Professor of Ophthalmology, Director of Retina Services, Department of Ophthalmology and Visual Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer I Lim, MD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Locations

UIC Eye and Ear Infirmary

Chicago, Illinois, United States

Countries

United States

References

Lim JI, Niec M, Wong V. One year results of a phase 1 study of the safety and tolerability of combination therapy using sustained release intravitreal triamcinolone acetonide and ranibizumab for subfoveal neovascular AMD. Br J Ophthalmol. 2015 May;99(5):618-23. doi: 10.1136/bjophthalmol-2014-306002. Epub 2014 Nov 6.

Reference Type: DERIVED

PMID: 25376617 (View on PubMed)

Related Links

http://www.uic.edu/com/eye/

UIC-Ophthalmology Home Page

Other Identifiers

2009-1067

Identifier Type: -

Identifier Source: org_study_id