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

Randomized, double-masked trial designed to investigate the use of TLC399 (ProDex) in subjects with macular edema due to CRVO or BRVO.

Study Overview

• Status: Completed
• Conditions: Retinal Vein Occlusion; Macula Edema
• Intervention / Treatment: Drug: TLC399 (ProDex)

Detailed Description

Part 1 is a randomized, double-maskedtrial trial designed to investigate the use of TLC399 in subjects with macular edema due to CRVO or BRVO. Three different dose strengths will be evaluated.

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.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. male or female, at least 18 years of age
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:

1. poorly controlled diabetes
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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; TLC399 (ProDex) 0.36mg DSP with 100 mM PL	Drug: TLC399 (ProDex); 2-vial system: TLC399-DSP and TLC399-Lipid; Other Names: TLC399
Experimental: Group 2; TLC399 (ProDex) 0.6 mg DSP with 100 mM PL	Drug: TLC399 (ProDex); 2-vial system: TLC399-DSP and TLC399-Lipid; Other Names: TLC399
Experimental: Group 3; TLC399 (ProDex) 0.6 mg DSP with 50 mM PL	Drug: TLC399 (ProDex); 2-vial system: TLC399-DSP and TLC399-Lipid; Other Names: TLC399
Experimental: Group 4; TLC399 (ProDex) 0.84 mg DSP with 50 mM PL	Drug: TLC399 (ProDex); 2-vial system: TLC399-DSP and TLC399-Lipid; Other Names: TLC399

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Taiwan Liposome Company
• Investigators: Study Director: Yvonne Shih, Taiwan Liposome Company, Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Actual): February 4, 2019
• Study Completion (Actual): February 4, 2019

Study Registration Dates

• First Submitted: March 22, 2017
• First Submitted That Met QC Criteria: March 22, 2017
• First Posted (Actual): March 28, 2017

Study Record Updates

• Last Update Posted (Actual): December 23, 2021
• Last Update Submitted That Met QC Criteria: November 24, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Retinal Degeneration; Retinal Diseases; Embolism and Thrombosis; Venous Thrombosis; Thrombosis; Macular Degeneration; Macular Edema; Retinal Vein Occlusion; Edema
• Other Study ID Numbers: TLC399A2002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No