TLC399 (ProDex) in Subjects With Macular Edema Due to Retinal Vein Occlusion (RVO)
1 other identifier
interventional
31
1 country
20
Brief Summary
Randomized, double-masked trial designed to investigate the use of TLC399 (ProDex) in subjects with macular edema due to CRVO or BRVO.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Apr 2017
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 22, 2017
CompletedFirst Posted
Study publicly available on registry
March 28, 2017
CompletedStudy Start
First participant enrolled
April 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 4, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 4, 2019
CompletedResults Posted
Study results publicly available
December 23, 2021
CompletedDecember 23, 2021
November 1, 2021
1.8 years
March 22, 2017
November 24, 2021
November 24, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of Subjects With BCVA Gain of 15 or More Letters From Baseline in the Study Eye
Proportion of subjects with BCVA gain of 15 or more letters from baseline in the study eye. Patients who received rescue medication/procedures within 6 months after the study treatment was initiated were considered failure to achieve a gain of at least 15 BCVA letters.
6 months after dosing
Study Arms (4)
Group 1
EXPERIMENTALTLC399 (ProDex) 0.36mg DSP with 100 mM PL
Group 2
EXPERIMENTALTLC399 (ProDex) 0.6 mg DSP with 100 mM PL
Group 3
EXPERIMENTALTLC399 (ProDex) 0.6 mg DSP with 50 mM PL
Group 4
EXPERIMENTALTLC399 (ProDex) 0.84 mg DSP with 50 mM PL
Interventions
2-vial system: TLC399-DSP and TLC399-Lipid
Eligibility Criteria
You may qualify if:
- male or female, at least 18 years of age
- macular edema due to CRVO or BRVO
- best-corrected visual acuity (BCVA) score of 20/40 to 20/400
- mean central subfield thickness (CST) ≥350 um
- willing and able to comply with the study procedure and sign a written informed consent
- agree to use a medically acceptable form of birth control
You may not qualify if:
- poorly controlled diabetes
- history of significant intraocular pressure (IOP) elevation to steroid treatment
- history of ocular hypertension and glaucoma
- cataract surgery in the study eye within 3 months, or intraocular surgery within 6 months prior to screening
- use of hemodilution for the treatment of RVO
- use of IVT ranibizumab or bevacizumab in the study eye within 6 weeks prior to screening; or IVT aflibercept within 8 weeks prior to screening
- IVT Ozurdex to the study eye within 6 months prior to screening
- prior use of Retisert or Iluvien
- use of systemic steroids or heparin within 1 month prior to screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Retinal Research Institute
Phoenix, Arizona, 85014, United States
Retina Institute of California
Arcadia, California, 91007, United States
Retina-Vitreous Associates Medical Group
Beverly Hills, California, 90211, United States
Retina Institute of California
Palm Desert, California, 92260, United States
Colorado Retina Associates
Golden, Colorado, 80401, United States
Retina Group of New England
New London, Connecticut, 09320, United States
Retina Macula Specialists of Miami
Miami, Florida, 33126, United States
Georgia Retina, P.C
Marietta, Georgia, 30060, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114, United States
Retina Consultants of Nevada
Las Vegas, Nevada, 89149, United States
Retina Associates of Western New York, PC
Rochester, New York, 14620, United States
Charlotte Eye Ear Nose & Throat Assoc, PA
Charlotte, North Carolina, 28210, United States
The Cleveland Clinic
Cleveland, Ohio, 44915, United States
Retina Research Institute of Texas
Abilene, Texas, 79606, United States
Retina Research Center
Austin, Texas, 78705, United States
Retina Consultants of Houston
Houston, Texas, 77030, United States
Medical Center Ophthalmology Associates
San Antonio, Texas, 78240, United States
Retinal Consultants of San Antonio
San Antonio, Texas, 78240, United States
Retina Consultants of Houston,The Woodlands
The Woodlands, Texas, 77384, United States
University of Virginia
Charlottesville, Virginia, 22903, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Carl Brown
- Organization
- Taiwan Liposome Company
Study Officials
- STUDY DIRECTOR
Yvonne Shih
Taiwan Liposome Company, Ltd.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2017
First Posted
March 28, 2017
Study Start
April 1, 2017
Primary Completion
February 4, 2019
Study Completion
February 4, 2019
Last Updated
December 23, 2021
Results First Posted
December 23, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will not share