Retinal Vein OcclusionPhase 2NCT03093701
TLC399 (ProDex) in Subjects With Macular Edema Due to Retinal Vein Occlusion (RVO)
A Phase 2 study testing TLC399 (ProDex) in people with Retinal Vein Occlusion and Macula Edema, run by Taiwan Liposome Company at 20 sites in United States.
Trial summary
Randomized, double-masked trial designed to investigate the use of TLC399 (ProDex) in subjects with macular edema due to CRVO or BRVO. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Vein Occlusion, Macula Edema
- What is being tested?
- TLC399 (ProDex)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 20 sitesUnited States
- Study dates
- 1 Apr 2017to 4 Feb 2019
- Phase
- Phase 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Retina Research Institute of Texas
Abilene, Texas, 79606
Retina Institute of California
Arcadia, California, 91007
Retina Research Center
Austin, Texas, 78705
Retina-Vitreous Associates Medical Group
Beverly Hills, California, 90211
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114
Charlotte Eye Ear Nose & Throat Assoc, PA
Charlotte, North Carolina, 28210
University of Virginia
Charlottesville, Virginia, 22903
The Cleveland Clinic
Cleveland, Ohio, 44915
Colorado Retina Associates
Golden, Colorado, 80401
Retina Consultants of Houston
Houston, Texas, 77030
Retina Consultants of Nevada
Las Vegas, Nevada, 89149
Georgia Retina, P.C
Marietta, Georgia, 30060
Retina Macula Specialists of Miami
Miami, Florida, 33126
Retina Group of New England
New London, Connecticut, 09320
Retina Institute of California
Palm Desert, California, 92260
Retinal Research Institute
Phoenix, Arizona, 85014
Retina Associates of Western New York, PC
Rochester, New York, 14620
Medical Center Ophthalmology Associates
San Antonio, Texas, 78240
Retinal Consultants of San Antonio
San Antonio, Texas, 78240
Retina Consultants of Houston,The Woodlands
The Woodlands, Texas, 77384
About this study
Randomized, double-masked trial designed to investigate the use of TLC399 (ProDex) in subjects with macular edema due to CRVO or BRVO.
Read the detailed description
Part 1 is a randomized, double-maskedtrial trial designed to investigate the use of TLC399 in subjects with macular edema due to CRVO or BRVO. Three different dose strengths will be evaluated.
Part 2 is a randomized, double-masked study designed to evaluate 2 doses of TLC399 in subjects with macular edema due to CRVO or BRVO. Subjects will be randomized 1:1 to receive two different dose strenghs of investigational product.
- Conditions
- Retinal Vein Occlusion, Macula Edema
- Being tested
- TLC399 (ProDex)
- Medical subject headings
- Retinal Vein Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TLC399 (ProDex)Drug
Also called TLC399
2-vial system: TLC399-DSP and TLC399-Lipid
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | TLC399 (ProDex) 0.36mg DSP with 100 mM PL Receives: Drug: TLC399 (ProDex) |
| Group 2 | Experimental | TLC399 (ProDex) 0.6 mg DSP with 100 mM PL Receives: Drug: TLC399 (ProDex) |
| Group 3 | Experimental | TLC399 (ProDex) 0.6 mg DSP with 50 mM PL Receives: Drug: TLC399 (ProDex) |
| Group 4 | Experimental | TLC399 (ProDex) 0.84 mg DSP with 50 mM PL Receives: Drug: TLC399 (ProDex) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Subjects With BCVA Gain of 15 or More Letters From Baseline in the Study Eye
Proportion of subjects with BCVA gain of 15 or more letters from baseline in the study eye.
Patients who received rescue medication/procedures within 6 months after the study treatment was initiated were considered failure to achieve a gain of at least 15 BCVA letters.
Measured: 6 months after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2017
- Study start1 Apr 2017
- Primary completion4 Feb 2019
- Study completion4 Feb 2019
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 Retinal Vein OcclusionStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taiwan Liposome Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yvonne Shih, Study director, Taiwan Liposome Company, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03093701
- Sponsor's protocol ID
- TLC399A2002
- Status last verified
- Nov 2021
- First submitted
- 22 Mar 2017
- Last updated
- 23 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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
- TLC399 (ProDex) in Subjects With Macular Edema Due to Retinal Vein Occlusion (RVO)
- ClinicalTrials.gov ID
- NCT03093701
- Acronym / sponsor ID
- TLC399A2002
- Conditions
- Retinal Vein Occlusion, Macula Edema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Taiwan Liposome CompanyIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 4 Feb 2019 (actual)
- Study completion
- 4 Feb 2019 (actual)
- First posted
- 28 Mar 2017 (actual)
- 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.
Randomized, double-masked trial designed to investigate the use of TLC399 (ProDex) in subjects with macular edema due to CRVO or BRVO.
Detailed description
Part 1 is a randomized, double-maskedtrial trial designed to investigate the use of TLC399 in subjects with macular edema due to CRVO or BRVO. Three different dose strengths will be evaluated.
Part 2 is a randomized, double-masked study designed to evaluate 2 doses of TLC399 in subjects with macular edema due to CRVO or BRVO. Subjects will be randomized 1:1 to receive two different dose strenghs of investigational product.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: TLC399 (ProDex)TLC399 (ProDex) 0.36mg DSP with 100 mM PL |
| Group 2 | Experimental | Drug: TLC399 (ProDex)TLC399 (ProDex) 0.6 mg DSP with 100 mM PL |
| Group 3 | Experimental | Drug: TLC399 (ProDex)TLC399 (ProDex) 0.6 mg DSP with 50 mM PL |
| Group 4 | Experimental | Drug: TLC399 (ProDex)TLC399 (ProDex) 0.84 mg DSP with 50 mM PL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| TLC399 (ProDex)Also: TLC3992-vial system: TLC399-DSP and TLC399-Lipid | Drug | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
Proportion of Subjects With BCVA Gain of 15 or More Letters From Baseline in the Study Eye
Time frame: 6 months after dosing
Proportion of subjects with BCVA gain of 15 or more letters from baseline in the study eye. Patients who received rescue medication/procedures within 6 months after the study treatment was initiated were considered failure to achieve a gain of at least 15 BCVA letters.
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.
- Individual participant dataSharing planned: No
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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.
Yvonne Shih study director
Taiwan Liposome Company, Ltd.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TLC399 (ProDex) in people with Retinal Vein Occlusion and Macula Edema, run by Taiwan Liposome Company at 20 sites in United States.
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 6 inclusion and 9 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 20 sites in United States. 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 phase mean?
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?
Proportion of Subjects With BCVA Gain of 15 or More Letters From Baseline in the Study Eye (time frame: 6 months after dosing). 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.