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

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

Detailed Description
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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.

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

Conditions
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Retinal Vein Occlusion, Macula Edema

Intervention / Treatment
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* Drug: TLC399 (ProDex)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 |