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

Taiwan Liposome Company31 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Retinal Vein Occlusion Macula Edema

Interventions

TLC399 (ProDex)DRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (20)

Retinal Research Institute

Phoenix, Arizona, United States

Outcomes

Primary Outcomes

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.

Time frame: 6 months after dosing

Data from ClinicalTrials.gov

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