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 range
20 Years
Sex
ALL
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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