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
Status
Type
Phase
Placebo
Accepting
Trial Timing
Ended 7 years ago
What is this trial about?
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
