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TLC399 (ProDex) in Subjects With Macular Edema Due to Retinal Vein Occlusion (RVO)

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ClinicalTrials.gov Identifier: NCT03093701
Recruitment Status : Suspended (Strategic review of unblinded data to optimize doses)
First Posted : March 28, 2017
Last Update Posted : May 1, 2018
Sponsor:
Information provided by (Responsible Party):
Taiwan Liposome Company

Brief Summary:
Subjects with macular edema will be screened and eligible subject will be enrolled to receive a single dose of the study drug (TLC399) with either of the three dose strengths by intravitreal (IVT) route. Each of the three groups will include approximately 22 subjects. The subjects will be followed for visual acuity, safety, tolerability and retinal thickness assessment after the single IVT injection of the study drug on Day 1.

Condition or disease Intervention/treatment Phase
Retinal Vein Occlusion Macula Edema Drug: TLC399 (ProDex) Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase IIa Trial of TLC399 (ProDex) in Subjects With Macular Edema Due to Retinal Vein Occlusion (RVO): A Double-masked, Randomized Trial to Evaluate Efficacy and Tolerability
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Experimental: Group 1
TLC399 (ProDex)
Drug: TLC399 (ProDex)
TLC399-DSP with TLC399-Lipid

Experimental: Group 2
TLC399 (ProDex)
Drug: TLC399 (ProDex)
TLC399-DSP with TLC399-Lipid

Experimental: Group 3
TLC399 (ProDex)
Drug: TLC399 (ProDex)
TLC399-DSP with TLC399-Lipid




Primary Outcome Measures :
  1. BCVA score [ Time Frame: 6 months ]
    Proportion of subjects with BCVA gain of 15 or more letters from baseline in the study eye



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be male or female, at least 18 years of age.
  • Have macular edema due to CRVO or BRVO
  • Have a best-corrected visual acuity (BCVA) score of 20/40 to 20/400
  • Have a mean central subfield thickness (CST) ≥350 um
  • Be willing and able to comply with the study procedure and sign a written informed consent.
  • Must agree to use a medically acceptable form of birth control

Exclusion Criteria:

  • 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 the Screening Visit
  • Use of hemodilution for the treatment of RVO
  • Use of IVT ranibizumab or bevacizumab in the study eye within 6 weeks prior to the Screening Visit; or IVT aflibercept within 8 weeks prior to the Screening Visit.
  • IVT Ozurdex to the study eye within 6 months prior to the Screening Visit.
  • Prior use of Retisert or Iluvien
  • Use of systemic steroids or heparin within 1 month prior to the Screening Visit

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03093701


Locations
United States, Arizona
Retinal Research Institute
Phoenix, Arizona, United States, 85014
United States, California
Retina Institute of California
Arcadia, California, United States, 91007
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States, 90211
Retina Institute of California
Palm Desert, California, United States, 92260
United States, Colorado
Colorado Retina Associates
Golden, Colorado, United States, 80401
United States, Connecticut
Retina Group of New England
New London, Connecticut, United States, 09320
United States, Florida
Retina Macula Specialists of Miami
Miami, Florida, United States, 33126
United States, Georgia
Georgia Retina, P.C
Marietta, Georgia, United States, 30060
United States, Massachusetts
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States, 02114
United States, Nevada
Retina Consultants of Nevada
Las Vegas, Nevada, United States, 89149
United States, New York
Retina Associates of Western New York, PC
Rochester, New York, United States, 14620
United States, North Carolina
Charlotte Eye Ear Nose & Throat Assoc, PA
Charlotte, North Carolina, United States, 28210
United States, Ohio
The Cleveland Clinic
Cleveland, Ohio, United States, 44915
United States, Texas
Retina Research Institute of Texas
Abilene, Texas, United States, 79606
Retina Research Center
Austin, Texas, United States, 78705
Retina Consultants of Houston
Houston, Texas, United States, 77030
Medical Center Ophthalmology Associates
San Antonio, Texas, United States, 78240
Retinal Consultants of San Antonio
San Antonio, Texas, United States, 78240
Retina Consultants of Houston,The Woodlands
The Woodlands, Texas, United States, 77384
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22903
Sponsors and Collaborators
Taiwan Liposome Company
Investigators
Study Director: Yvonne Shih Taiwan Liposome Company, Ltd.

Responsible Party: Taiwan Liposome Company
ClinicalTrials.gov Identifier: NCT03093701     History of Changes
Other Study ID Numbers: TLC399A2002
First Posted: March 28, 2017    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Edema
Macular Edema
Retinal Vein Occlusion
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases