20089 TA+Lucentis Combo Intravitreal Injections for Treatment of Neovascular Age-related Macular Degeneration (AMD)
20089/Combo
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
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Sep 2010
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 2, 2010
CompletedFirst Posted
Study publicly available on registry
August 4, 2010
CompletedStudy Start
First participant enrolled
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedResults Posted
Study results publicly available
October 20, 2014
CompletedOctober 20, 2014
October 1, 2014
2.3 years
August 2, 2010
May 23, 2013
October 13, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
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.
360 Days
Secondary Outcomes (1)
To Determine the Number of Retreatments With Lucentis in Eyes Initially Treated With 20089 TA and Lucentis
30 to 360 days
Study Arms (1)
IBI-20089/Lucentis
EXPERIMENTALAlternate treatment of either 6.9 mg IBI-20089/Lucentis or 13.8 mg IBI-20089/Lucentis
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Illinois at Chicagolead
- ICON Bioscience Inccollaborator
Study Sites (1)
UIC Eye and Ear Infirmary
Chicago, Illinois, 60612, United States
Related Publications (1)
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.
PMID: 25376617DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jennifer I Lim MD
- Organization
- University of Illinois at Chicago
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer I Lim, MD
University of Illinois at Chicago
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Ophthalmology, Director of Retina Services, Department of Ophthalmology and Visual Sciences
Study Record Dates
First Submitted
August 2, 2010
First Posted
August 4, 2010
Study Start
September 1, 2010
Primary Completion
January 1, 2013
Study Completion
January 1, 2013
Last Updated
October 20, 2014
Results First Posted
October 20, 2014
Record last verified: 2014-10