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

• Status: Completed
• Trial end date: 2019-02-04
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taiwan Liposome Company

Criteria

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