Central Retinal Vein Occlusion With Macular EdemaPhase 1/2NCT02006147
Phase 1 Open-label Study to Evaluate Efficacy and Tolerability of TLC399 in Patients With Macular Edema Due to RVO
A Phase 1/2 study testing TLC399 in people with Central Retinal Vein Occlusion With Macular Edema and Branch Retinal Vein Occlusion With Macular Edema, run by Taiwan Liposome Company at 6 sites in Taiwan.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Central Retinal Vein Occlusion With Macular Edema, Branch Retinal Vein Occlusion With Macular Edema
- What is being tested?
- TLC399
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 6 sitesTaiwan
- Study dates
- Nov 2014to 15 Jul 2020
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 central serous chorioretinopathy in either eye.
- Presence of rubeosis iridis in the study eye.
- Any active ocular infection in either eye.
- History of herpetic ocular infection in the study eye or adnexa.
- Presence of active or inactive toxoplasmosis in either eye.
- Presence of visible scleral thinning or ectasia in the study eye.
- Media opacity in the study eye that precludes clinical and photographic evaluation.
- Intraocular surgery in the stydy eye within 6 months.
- History of pars plana vitrectomy, radial optic neurotomy, or sheathotomy in the study eye.
- Anticipated need for ocular surgery in the study eye during the 12-months study period.
- Use of hemodilution for the treatment of RVO within 3 months.
- Use of any intraocular anti-VEGF therapy in the study eye.
- Use of laser of any type in the study eye within 3 months.
- Previous use of intravitreal steroids in the study eye within 6 months.
- Periocular depot of steroids to the study eye within 1 month.
- Use of systemic sterois, or warfarin/heparin within 1 month.
- Use of immunosuppressants, immunomodulators, antimetabolites, and/or alkylating agents within 6 months.
- BCVA score <34 letters in the non-study eye.
- Known allergy or hypersensitivity to the study medication or its components.
- Known allergy or contraindication to the use of fluorescein or povidone iodine or contraindication to pupil dilation in either eye.
- Female patients who are pregnant, nursing, or planning a pregnancy, or who are of childbearing potential and not using a reliable means of contraception.
- Current enrollment in an investigational drug or device study or participation in such a study within 90 days.
- Patient has a condition or is in a situation which will interfere with the patient's ability to comply with the dosig and visit schedules and the protocol evaluations or may not suitable for this study.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Taiwan6 sites
Changhua Christian Medical Foundation Changhua Christian Hospital
Chang-hua
Kaohsiung Veterans General Hospital
Kaohsiung City
National Taiwan University Hospital
Taipei
Shin Kong Wu Ho-Su Memorial Hospital
Taipei
Taipei Veterans General Hospital
Taipei
Chang Gung Memorial Hospital, Linkou Branch
Taoyuan
About this study
Official title: Phase I/II Trial of TLC399 (ProDex) in Patients With Macular Edema Due to Retinal Vein Occlusion (RVO)
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).
Read the detailed description
<Part 1> An open-label, sequential dose escalation part to determine the DLT of TLC399 (ProDex) in patients with macular edema due to central retinal vein occlusion (CRVO) or branch retinal vein occlusion (BRVO). The safety results should be evaluated by Safety Monitor Committee regularly every 6 months and after last patient of each cohort completes DLT observation period. The SMC would advise or give permission for further dose escalation, de-escalation, or any study design adjustment. After the study drug administration, these patients will continue to be evaluated for efficacy and safety outcomes up to a period of 12 months unless the patient is withdrawn or discontinues the study.
- Group R1: 0.24 mg DSP with 100 mM PL (20 µL)
- Group 1: 0.36 mg DSP with 100 mM PL (30 µL)
- Group 2: 0.6 mg DSP with 100 mM PL (50 µL)
- Group 3: 0.6 mg DSP with 50 mM PL (50 µL)
<Part 2> An open-label, single-arm design to investigate the use of TLC399 (ProDex) in patients with macular edema due to CRVO or BRVO in one dose level selected from Part 1. The enrollment of subjects for analysis will include approximately 20 patients in total, inclusive of Part 1 and Part 2 for the selected dose group. The safety and efficacy outcomes will be assessed for up to 12 months.
- Conditions
- Central Retinal Vein Occlusion With Macular Edema, Branch Retinal Vein Occlusion With Macular Edema
- Being tested
- TLC399
- Keywords
- Macular Edema, RVO
- Medical subject headings
- Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TLC399Drug
Also called TLC399 (BioSeizer)
Dose-escalation Study from 100 mM PL (20 µL) with 0.24 mg DSP to 100 mM PL (20 µL) with0.36 mg DSP to 100 mM PL (20 µL) with 0.6 mg DSP to 50 mM PL (10 µL) with 0.6 mg DSP.
| Study group | Role | What they receive |
|---|---|---|
| TLC399 (Group 1) | Experimental | TLC399 is manufactured with the proprietary lipid formulation in lyophilized form (BioSeizer) for the reconstitution with the aqueous DSP. Receives: Drug: TLC399 |
| TLC399 (Group R1) | Experimental | TLC399 is manufactured with the proprietary lipid formulation in lyophilized form (BioSeizer) for the reconstitution with the aqueous DSP. Receives: Drug: TLC399 |
| TLC399 (Group 2) | Experimental | TLC399 is manufactured with the proprietary lipid formulation in lyophilized form (BioSeizer) for the reconstitution with the aqueous DSP. Receives: Drug: TLC399 |
| TLC399 (Group 3) | Experimental | TLC399 is manufactured with the proprietary lipid formulation in lyophilized form (BioSeizer) for the reconstitution with the aqueous DSP. Receives: Drug: TLC399 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Dose-limiting Toxicity (DLT)
Ocular AEs
Measured: 4 weeks
Part 2: Safety Assessment: Number of SAEs and Treatment-related Severe AEs
Number of SAEs and treatment-related severe AEs
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2013 (estimated)
- Study startNov 2014
- Primary completion15 Jul 2020
- Study completion15 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Central Retinal Vein Occlusion With Macular EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taiwan Liposome Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carl Brown, PhD, Study director, Taiwan Liposome Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02006147
- Sponsor's protocol ID
- TLC399.1
- Status last verified
- Nov 2021
- First submitted
- 13 Nov 2013
- Last updated
- 23 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Trial of TLC399 (ProDex) in Patients With Macular Edema Due to Retinal Vein Occlusion (RVO)
- ClinicalTrials.gov ID
- NCT02006147
- Acronym / sponsor ID
- TLC399.1
- Conditions
- Central Retinal Vein Occlusion With Macular Edema, Branch Retinal Vein Occlusion With Macular Edema
- Keywords
- Macular Edema, RVO
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Taiwan Liposome CompanyIndustry (pharma, biotech, devices)
- Study start
- Nov 2014 (actual)
- Primary completion
- 15 Jul 2020 (actual)
- Study completion
- 15 Jul 2020 (actual)
- First posted
- 10 Dec 2013 (estimated)
- Results
- Posted 23 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
<Part 1> An open-label, sequential dose escalation part to determine the DLT of TLC399 (ProDex) in patients with macular edema due to central retinal vein occlusion (CRVO) or branch retinal vein occlusion (BRVO). The safety results should be evaluated by Safety Monitor Committee regularly every 6 months and after last patient of each cohort completes DLT observation period. The SMC would advise or give permission for further dose escalation, de-escalation, or any study design adjustment. After the study drug administration, these patients will continue to be evaluated for efficacy and safety outcomes up to a period of 12 months unless the patient is withdrawn or discontinues the study.
- Group R1: 0.24 mg DSP with 100 mM PL (20 µL)
- Group 1: 0.36 mg DSP with 100 mM PL (30 µL)
- Group 2: 0.6 mg DSP with 100 mM PL (50 µL)
- Group 3: 0.6 mg DSP with 50 mM PL (50 µL)
<Part 2> An open-label, single-arm design to investigate the use of TLC399 (ProDex) in patients with macular edema due to CRVO or BRVO in one dose level selected from Part 1. The enrollment of subjects for analysis will include approximately 20 patients in total, inclusive of Part 1 and Part 2 for the selected dose group. The safety and efficacy outcomes will be assessed for up to 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TLC399 (Group 1) | Experimental | Drug: TLC399TLC399 is manufactured with the proprietary lipid formulation in lyophilized form (BioSeizer) for the reconstitution with the aqueous DSP. |
| TLC399 (Group R1) | Experimental | Drug: TLC399TLC399 is manufactured with the proprietary lipid formulation in lyophilized form (BioSeizer) for the reconstitution with the aqueous DSP. |
| TLC399 (Group 2) | Experimental | Drug: TLC399TLC399 is manufactured with the proprietary lipid formulation in lyophilized form (BioSeizer) for the reconstitution with the aqueous DSP. |
| TLC399 (Group 3) | Experimental | Drug: TLC399TLC399 is manufactured with the proprietary lipid formulation in lyophilized form (BioSeizer) for the reconstitution with the aqueous DSP. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (35 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TLC399Also: TLC399 (BioSeizer)Dose-escalation Study from 100 mM PL (20 µL) with 0.24 mg DSP to 100 mM PL (20 µL) with0.36 mg DSP to 100 mM PL (20 µL) with 0.6 mg DSP to 50 mM PL (10 µL) with 0.6 mg DSP. | Drug | TLC399 (Group 1), TLC399 (Group 2), TLC399 (Group 3), TLC399 (Group R1) |
Primary outcome
Part 1: Dose-limiting Toxicity (DLT)
Time frame: 4 weeks
Ocular AEs
Part 2: Safety Assessment: Number of SAEs and Treatment-related Severe AEs
Time frame: Up to 1 year
Number of SAEs and treatment-related severe AEs
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carl Brown, PhD study director
Taiwan Liposome Company
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TLC399 in people with Central Retinal Vein Occlusion With Macular Edema and Branch Retinal Vein Occlusion With Macular Edema, run by Taiwan Liposome Company at 6 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: Dose-limiting Toxicity (DLT) (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2021.