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

Taiwan Liposome Company (TLC)

Status and phase: Completed; Phase 2

Conditions: Macula Edema; Retinal Vein Occlusion

Treatments: Drug: TLC399 (ProDex)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03093701

TLC399A2002

Details and patient eligibility

About

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

Full 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.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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31 participants in 4 patient groups

Group 1

Experimental group

Description:

TLC399 (ProDex) 0.36mg DSP with 100 mM PL

Treatment:

Drug: TLC399 (ProDex)

Group 2

Experimental group

Description:

TLC399 (ProDex) 0.6 mg DSP with 100 mM PL

Treatment:

Drug: TLC399 (ProDex)

Group 3

Experimental group

Description:

TLC399 (ProDex) 0.6 mg DSP with 50 mM PL

Treatment:

Drug: TLC399 (ProDex)

Group 4

Experimental group

Description:

TLC399 (ProDex) 0.84 mg DSP with 50 mM PL

Treatment:

Drug: TLC399 (ProDex)