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

Sponsored by Taiwan Liposome Company

About this trial

Last updated 4 years ago

Study ID

TLC399A2002

Status

Completed

Type

Interventional

Phase

Phase 2

Placebo

No

Accepting

18+ Years
All Sexes

Trial Timing

Ended 7 years ago

What is this trial about?

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

What are the participation requirements?

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