TLC399 (ProDex) in Subjects With Macular Edema Due to Retinal Vein Occlusion (RVO)
NCT ID: NCT03093701
Last Updated: 2021-12-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
31 participants
INTERVENTIONAL
2017-04-01
2019-02-04
Brief Summary
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Detailed Description
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Part 2 is a randomized, double-masked study designed to evaluate 2 doses of TLC399 in subjects with macular edema due to CRVO or BRVO. Subjects will be randomized 1:1 to receive two different dose strenghs of investigational product.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Group 1
TLC399 (ProDex) 0.36mg DSP with 100 mM PL
TLC399 (ProDex)
2-vial system: TLC399-DSP and TLC399-Lipid
Group 2
TLC399 (ProDex) 0.6 mg DSP with 100 mM PL
TLC399 (ProDex)
2-vial system: TLC399-DSP and TLC399-Lipid
Group 3
TLC399 (ProDex) 0.6 mg DSP with 50 mM PL
TLC399 (ProDex)
2-vial system: TLC399-DSP and TLC399-Lipid
Group 4
TLC399 (ProDex) 0.84 mg DSP with 50 mM PL
TLC399 (ProDex)
2-vial system: TLC399-DSP and TLC399-Lipid
Interventions
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TLC399 (ProDex)
2-vial system: TLC399-DSP and TLC399-Lipid
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. macular edema due to CRVO or BRVO
3. best-corrected visual acuity (BCVA) score of 20/40 to 20/400
4. mean central subfield thickness (CST) ≥350 um
5. willing and able to comply with the study procedure and sign a written informed consent
6. agree to use a medically acceptable form of birth control
Exclusion Criteria
2. history of significant intraocular pressure (IOP) elevation to steroid treatment
3. history of ocular hypertension and glaucoma
4. cataract surgery in the study eye within 3 months, or intraocular surgery within 6 months prior to screening
5. use of hemodilution for the treatment of RVO
6. 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
7. IVT Ozurdex to the study eye within 6 months prior to screening
8. prior use of Retisert or Iluvien
9. use of systemic steroids or heparin within 1 month prior to screening
18 Years
ALL
No
Sponsors
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Taiwan Liposome Company
INDUSTRY
Responsible Party
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Principal Investigators
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Yvonne Shih
Role: STUDY_DIRECTOR
Taiwan Liposome Company, Ltd.
Locations
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Retinal Research Institute
Phoenix, Arizona, United States
Retina Institute of California
Arcadia, California, United States
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States
Retina Institute of California
Palm Desert, California, United States
Colorado Retina Associates
Golden, Colorado, United States
Retina Group of New England
New London, Connecticut, United States
Retina Macula Specialists of Miami
Miami, Florida, United States
Georgia Retina, P.C
Marietta, Georgia, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States
Retina Consultants of Nevada
Las Vegas, Nevada, United States
Retina Associates of Western New York, PC
Rochester, New York, United States
Charlotte Eye Ear Nose & Throat Assoc, PA
Charlotte, North Carolina, United States
The Cleveland Clinic
Cleveland, Ohio, United States
Retina Research Institute of Texas
Abilene, Texas, United States
Retina Research Center
Austin, Texas, United States
Retina Consultants of Houston
Houston, Texas, United States
Medical Center Ophthalmology Associates
San Antonio, Texas, United States
Retinal Consultants of San Antonio
San Antonio, Texas, United States
Retina Consultants of Houston,The Woodlands
The Woodlands, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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TLC399A2002
Identifier Type: -
Identifier Source: org_study_id