Phase 2
N=31
TLC399 (ProDex) in Subjects With Macular Edema Due to Retinal Vein Occlusion (RVO)
Retinal Vein Occlusion · Macula Edema
Bottom Line
View on ClinicalTrials.gov: NCT03093701 ↗Enrolled (actual)
31
Serious AEs
9.7%
Results posted
Dec 2021
Primary outcome: Primary: Proportion of Subjects With BCVA Gain of 15 or More Letters From Baseline in the Study Eye — 1; 1; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- TLC399 (ProDex) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Taiwan Liposome Company
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Subjects With BCVA Gain of 15 or More Letters From Baseline in the Study Eye |
1; 1; 1 | — |
Summary
Randomized, double-masked trial designed to investigate the use of TLC399 (ProDex) in subjects with macular edema due to CRVO or BRVO.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
- use of systemic steroids or heparin within 1 month prior to screening
Data sourced from ClinicalTrials.gov (NCT03093701). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.