CompletedPhase 2

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

United States31 participantsStarted 2017-04-01

Plain-language summary

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

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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

Proportion of Subjects With BCVA Gain of 15 or More Letters From Baseline in the Study Eye

Timeframe: 6 months after dosing

NCT IDNCT03093701

SponsorTaiwan Liposome Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-02-04

Results submitted2021-11-24