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Completed

NCT Number: NCT03093701

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.

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Key information

Conditions

Retinal Vein Occlusion Cardiovascular Diseases Embolism and Thrombosis Eye Diseases Macula Edema Retinal Diseases Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Retinal Research Institute, Phoenix, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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 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

Treatment and study plan

TLC399 (ProDex)

Drug

2-vial system: TLC399-DSP and TLC399-Lipid

Other names: TLC399

Primary outcomes

  1. Proportion of Subjects With BCVA Gain of 15 or More Letters From Baseline in the Study Eye

    Time frame: 6 months after dosing

    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.

Sponsors and collaborators

Lead sponsor

Taiwan Liposome Company

Industry

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 28, 2017
Registry last updated
Dec 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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