Phase 1 Open-label Study to Evaluate Efficacy and Tolerability of TLC399 in Patients With Macular… (NCT02006147) | Clinical Trial Compass
CompletedPhase 1/2
Phase 1 Open-label Study to Evaluate Efficacy and Tolerability of TLC399 in Patients With Macular Edema Due to RVO
Taiwan14 participantsStarted 2014-11
Plain-language summary
To determine whether TLC399 (ProDex) provides an ideal, safe, long-acting, dexamethasone sodium phosphate (DSP) delivery system for the treatment of macular edema due to retinal vein occlusion (RVO).
Who can participate
Age range20 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female, \> 20 years of age.
* Patients with macular edema due to CRVO or BRVO diagnosed within 36 months.
* BCVA score of 20/40 to 20/400 by chart ETDRS in the study eye.
* Mean central subfield thickness ≥350uM on Spectral/Fourier domain by OCT measurements in the study eye.
* Willing and able to comply with the study procedure and sign a written informed consent.
Exclusion Criteria:
* Macular edema due to diabetic retinopathy or other etiologies.
* Brisk afferent pupillary defect.
* Stroke or myocardial infarction within 3 months.
* Uncontrolled systemic disease, or poorly controlled hypertension, or poorly controlled diabetes.
* Any ocular condition that in the opinion of the Investigator would prevent a 15-letter gain in visual acuity.
* Presence of an epiretinal membrane in the study eye which is the primary cause of macular edema, or is severe enough to prevent gain in visual acuity despite reduction in macular edema.
* History of clinically significant IOP elevation in response to steroid treatment.
* History of glaucoma or optic nerve head change consistent with glaucoma damage, and/or glaucomatous visual field loss in both eyes.
* Active ocular hypertension ≥21mmHg or history of treated ocular hypertension in the study eye.
* Aphakia or presence of anterior chamber intraocular lens in the study eye.
* Active retinal neovascularization in the study eye.
* Active or history of choroidal neovascularization in the study eye.
* History of …
What they're measuring
1
Part 1: Dose-limiting Toxicity (DLT)
Timeframe: 4 weeks
2
Part 2: Safety Assessment: Number of SAEs and Treatment-related Severe AEs