Phase 2 Completed N=31 Randomized Quadruple-blind Treatment

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

Source: ClinicalTrials.gov NCT03093701 ↗

Enrolled (actual)

Serious AEs

9.7%

Results posted

Dec 2021

Primary outcomePrimary: Proportion of Subjects With BCVA Gain of 15 or More Letters From Baseline in the Study Eye — 1; 1; 1 Participants

Summary

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

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	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.