TLC399 (ProDex) in Subjects With Macular Edema Due to Retinal Vein Occlusion (RVO)
Study Details
Study Description
Brief Summary
Randomized, double-masked trial designed to investigate the use of TLC399 (ProDex) in subjects with macular edema due to CRVO or BRVO.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
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
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Group 1 TLC399 (ProDex) 0.36mg DSP with 100 mM PL |
Drug: TLC399 (ProDex)
2-vial system: TLC399-DSP and TLC399-Lipid
Other Names:
|
Experimental: Group 2 TLC399 (ProDex) 0.6 mg DSP with 100 mM PL |
Drug: TLC399 (ProDex)
2-vial system: TLC399-DSP and TLC399-Lipid
Other Names:
|
Experimental: Group 3 TLC399 (ProDex) 0.6 mg DSP with 50 mM PL |
Drug: TLC399 (ProDex)
2-vial system: TLC399-DSP and TLC399-Lipid
Other Names:
|
Experimental: Group 4 TLC399 (ProDex) 0.84 mg DSP with 50 mM PL |
Drug: TLC399 (ProDex)
2-vial system: TLC399-DSP and TLC399-Lipid
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Proportion of Subjects With BCVA Gain of 15 or More Letters From Baseline in the Study Eye [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.
Eligibility Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Retinal Research Institute | Phoenix | Arizona | United States | 85014 |
2 | Retina Institute of California | Arcadia | California | United States | 91007 |
3 | Retina-Vitreous Associates Medical Group | Beverly Hills | California | United States | 90211 |
4 | Retina Institute of California | Palm Desert | California | United States | 92260 |
5 | Colorado Retina Associates | Golden | Colorado | United States | 80401 |
6 | Retina Group of New England | New London | Connecticut | United States | 09320 |
7 | Retina Macula Specialists of Miami | Miami | Florida | United States | 33126 |
8 | Georgia Retina, P.C | Marietta | Georgia | United States | 30060 |
9 | Ophthalmic Consultants of Boston | Boston | Massachusetts | United States | 02114 |
10 | Retina Consultants of Nevada | Las Vegas | Nevada | United States | 89149 |
11 | Retina Associates of Western New York, PC | Rochester | New York | United States | 14620 |
12 | Charlotte Eye Ear Nose & Throat Assoc, PA | Charlotte | North Carolina | United States | 28210 |
13 | The Cleveland Clinic | Cleveland | Ohio | United States | 44915 |
14 | Retina Research Institute of Texas | Abilene | Texas | United States | 79606 |
15 | Retina Research Center | Austin | Texas | United States | 78705 |
16 | Retina Consultants of Houston | Houston | Texas | United States | 77030 |
17 | Medical Center Ophthalmology Associates | San Antonio | Texas | United States | 78240 |
18 | Retinal Consultants of San Antonio | San Antonio | Texas | United States | 78240 |
19 | Retina Consultants of Houston,The Woodlands | The Woodlands | Texas | United States | 77384 |
20 | University of Virginia | Charlottesville | Virginia | United States | 22903 |
Sponsors and Collaborators
- Taiwan Liposome Company
Investigators
- Study Director: Yvonne Shih, Taiwan Liposome Company, Ltd.
Study Documents (Full-Text)
More Information
Publications
None provided.- TLC399A2002
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Group 1 | Group 2 | Group 3 | Group 4 |
---|---|---|---|---|
Arm/Group Description | TLC399 (ProDex) 0.36mg DSP with 100 mM PL TLC399 (ProDex): 2-vial system: TLC399-DSP and TLC399-Lipid | TLC399 (ProDex) 0.6 mg DSP with 100 mM PL TLC399 (ProDex): 2-vial system: TLC399-DSP and TLC399-Lipid | TLC399 (ProDex) 0.6 mg DSP with 50 mM PL TLC399 (ProDex): 2-vial system: TLC399-DSP and TLC399-Lipid | TLC399 (ProDex) 0.84 mg DSP with 50 mM PL TLC399 (ProDex): 2-vial system: TLC399-DSP and TLC399-Lipid |
Period Title: Overall Study | ||||
STARTED | 10 | 10 | 11 | 0 |
COMPLETED | 10 | 7 | 11 | 0 |
NOT COMPLETED | 0 | 3 | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Group 1 | Group 2 | Group 3 | Total |
---|---|---|---|---|
Arm/Group Description | TLC399 (ProDex) 0.36mg DSP with 100 mM PL TLC399 (ProDex): 2-vial system: TLC399-DSP and TLC399-Lipid | TLC399 (ProDex) 0.6 mg DSP with 100 mM PL TLC399 (ProDex): 2-vial system: TLC399-DSP and TLC399-Lipid | TLC399 (ProDex) 0.6 mg DSP with 50 mM PL TLC399 (ProDex): 2-vial system: TLC399-DSP and TLC399-Lipid | Total of all reporting groups |
Overall Participants | 10 | 10 | 11 | 31 |
Age (years) [Mean (Standard Deviation) ] | ||||
Mean (Standard Deviation) [years] |
72.1
(10.40)
|
63.5
(12.55)
|
68.5
(8.20)
|
68.1
(10.70)
|
Sex: Female, Male (Count of Participants) | ||||
Female |
3
30%
|
4
40%
|
1
9.1%
|
8
25.8%
|
Male |
7
70%
|
6
60%
|
10
90.9%
|
23
74.2%
|
Ethnicity (NIH/OMB) (Count of Participants) | ||||
Hispanic or Latino |
2
20%
|
3
30%
|
2
18.2%
|
7
22.6%
|
Not Hispanic or Latino |
8
80%
|
7
70%
|
8
72.7%
|
23
74.2%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
1
9.1%
|
1
3.2%
|
Race (NIH/OMB) (Count of Participants) | ||||
American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
1
9.1%
|
1
3.2%
|
Black or African American |
1
10%
|
1
10%
|
1
9.1%
|
3
9.7%
|
White |
9
90%
|
9
90%
|
9
81.8%
|
27
87.1%
|
More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Region of Enrollment (participants) [Number] | ||||
United States |
10
100%
|
10
100%
|
11
100%
|
31
100%
|
RVO Type (Count of Participants) | ||||
BRVO |
7
70%
|
6
60%
|
7
63.6%
|
20
64.5%
|
CRVO |
3
30%
|
4
40%
|
4
36.4%
|
11
35.5%
|
CST (study eye) (µm) [Mean (Standard Deviation) ] | ||||
Mean (Standard Deviation) [µm] |
530.6
(133.56)
|
776.9
(288.67)
|
702.1
(195.15)
|
670.9
(231.75)
|
BCVA (study eye) (letters) [Mean (Standard Deviation) ] | ||||
Mean (Standard Deviation) [letters] |
61.5
(7.40)
|
48.2
(16.94)
|
51.1
(16.66)
|
53.5
(15.10)
|
IOP (study eye) (mmHg) [Mean (Standard Deviation) ] | ||||
Mean (Standard Deviation) [mmHg] |
12.4
(2.63)
|
13.5
(3.41)
|
13.6
(2.69)
|
13.2
(2.88)
|
Outcome Measures
Title | Proportion of Subjects With BCVA Gain of 15 or More Letters From Baseline in the Study Eye |
---|---|
Description | 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. |
Time Frame | 6 months after dosing |
Outcome Measure Data
Analysis Population Description |
---|
The analysis population was based on subject's randomized treatment group. |
Arm/Group Title | Group 1 | Group 2 | Group 3 |
---|---|---|---|
Arm/Group Description | TLC399 (ProDex) 0.36mg DSP with 100 mM PL TLC399 (ProDex): 2-vial system: TLC399-DSP and TLC399-Lipid | TLC399 (ProDex) 0.6 mg DSP with 100 mM PL TLC399 (ProDex): 2-vial system: TLC399-DSP and TLC399-Lipid | TLC399 (ProDex) 0.6 mg DSP with 50 mM PL TLC399 (ProDex): 2-vial system: TLC399-DSP and TLC399-Lipid |
Measure Participants | 10 | 10 | 11 |
Count of Participants [Participants] |
1
10%
|
1
10%
|
1
9.1%
|
Adverse Events
Time Frame | 14 days (screening) + 1 year | |||||
---|---|---|---|---|---|---|
Adverse Event Reporting Description | Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects. | |||||
Arm/Group Title | Group 1 | Group 2 | Group 3 | |||
Arm/Group Description | TLC399 (ProDex) 0.36mg DSP with 100 mM PL TLC399 (ProDex): 2-vial system: TLC399-DSP and TLC399-Lipid | TLC399 (ProDex) 0.6 mg DSP with 100 mM PL TLC399 (ProDex): 2-vial system: TLC399-DSP and TLC399-Lipid | TLC399 (ProDex) 0.6 mg DSP with 50 mM PL TLC399 (ProDex): 2-vial system: TLC399-DSP and TLC399-Lipid | |||
All Cause Mortality |
||||||
Group 1 | Group 2 | Group 3 | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/10 (0%) | 0/8 (0%) | 0/13 (0%) | |||
Serious Adverse Events |
||||||
Group 1 | Group 2 | Group 3 | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/10 (0%) | 2/8 (25%) | 1/13 (7.7%) | |||
Cardiac disorders | ||||||
Pericardial effusion | 0/10 (0%) | 0/8 (0%) | 1/13 (7.7%) | |||
Eye disorders | ||||||
Vitreous haze | 0/10 (0%) | 1/8 (12.5%) | 0/13 (0%) | |||
Vitreous haze leading to significant vision loss | 0/10 (0%) | 1/8 (12.5%) | 0/13 (0%) | |||
Gastrointestinal disorders | ||||||
Acute coliti | 0/10 (0%) | 0/8 (0%) | 1/13 (7.7%) | |||
Infections and infestations | ||||||
Pneumonia | 0/10 (0%) | 0/8 (0%) | 1/13 (7.7%) | |||
Nervous system disorders | ||||||
Transient ischaemic attack | 0/10 (0%) | 0/8 (0%) | 1/13 (7.7%) | |||
Other (Not Including Serious) Adverse Events |
||||||
Group 1 | Group 2 | Group 3 | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 10/10 (100%) | 8/8 (100%) | 13/13 (100%) | |||
Blood and lymphatic system disorders | ||||||
Coagulopathy | 0/10 (0%) | 0/8 (0%) | 1/13 (7.7%) | |||
Anaemia | 0/10 (0%) | 0/8 (0%) | 1/13 (7.7%) | |||
Cardiac disorders | ||||||
Cardiomyopathy | 0/10 (0%) | 0/8 (0%) | 1/13 (7.7%) | |||
Pericardial effusion | 0/10 (0%) | 0/8 (0%) | 1/13 (7.7%) | |||
Ear and labyrinth disorders | ||||||
Tinnitus | 0/10 (0%) | 0/8 (0%) | 1/13 (7.7%) | |||
Eye disorders | ||||||
Vitreous haze | 10/10 (100%) | 8/8 (100%) | 13/13 (100%) | |||
Macular oedema | 4/10 (40%) | 2/8 (25%) | 5/13 (38.5%) | |||
Visual acuity reduced | 4/10 (40%) | 4/8 (50%) | 1/13 (7.7%) | |||
Conjunctival haemorrhage | 4/10 (40%) | 2/8 (25%) | 1/13 (7.7%) | |||
Vitreous floaters | 2/10 (20%) | 2/8 (25%) | 2/13 (15.4%) | |||
Vision blurred | 3/10 (30%) | 1/8 (12.5%) | 1/13 (7.7%) | |||
Corneal oedema | 1/10 (10%) | 1/8 (12.5%) | 1/13 (7.7%) | |||
Retinal vein occlusion | 0/10 (0%) | 0/8 (0%) | 2/13 (15.4%) | |||
Optic disc hyperaemia | 0/10 (0%) | 0/8 (0%) | 1/13 (7.7%) | |||
Retinal aneurysm | 1/10 (10%) | 0/8 (0%) | 1/13 (7.7%) | |||
Retinal vascular disorder | 0/10 (0%) | 1/8 (12.5%) | 1/13 (7.7%) | |||
Visual imparment | 1/10 (10%) | 0/8 (0%) | 1/13 (7.7%) | |||
Vitrous detachment | 0/10 (0%) | 2/8 (25%) | 0/13 (0%) | |||
Anterior chamber flare | 1/10 (10%) | 0/8 (0%) | 0/13 (0%) | |||
Cataract | 0/10 (0%) | 1/8 (12.5%) | 0/13 (0%) | |||
Cataract nulcear | 1/10 (10%) | 0/8 (0%) | 0/13 (0%) | |||
Conjunctival cyst | 0/10 (0%) | 0/8 (0%) | 1/13 (7.7%) | |||
Dry eye | 1/10 (10%) | 0/8 (0%) | 0/13 (0%) | |||
Eye pain | 0/10 (0%) | 1/8 (12.5%) | 0/13 (0%) | |||
Iris neovascularisation | 0/10 (0%) | 1/8 (12.5%) | 0/13 (0%) | |||
Macular fibrosis | 1/10 (10%) | 0/8 (0%) | 0/13 (0%) | |||
Macular pigmentation | 0/10 (0%) | 1/8 (12.5%) | 0/13 (0%) | |||
Maculopathy | 0/10 (0%) | 0/8 (0%) | 1/13 (7.7%) | |||
Retinal disorder | 1/10 (10%) | 0/8 (0%) | 0/13 (0%) | |||
Retinal exudates | 1/10 (10%) | 0/8 (0%) | 0/13 (0%) | |||
Retinal haemorrhage | 0/10 (0%) | 0/8 (0%) | 1/13 (7.7%) | |||
Retinal neovascularisation | 0/10 (0%) | 1/8 (12.5%) | 0/13 (0%) | |||
Retinal scar | 0/10 (0%) | 1/8 (12.5%) | 0/13 (0%) | |||
Vitreous disorder | 0/10 (0%) | 0/8 (0%) | 1/13 (7.7%) | |||
Vitreous haemorrhage | 0/10 (0%) | 0/8 (0%) | 1/13 (7.7%) | |||
Vitreous opacities | 1/10 (10%) | 0/8 (0%) | 0/13 (0%) | |||
Retinal thickening | 1/10 (10%) | 1/8 (12.5%) | 0/13 (0%) | |||
Gastrointestinal disorders | ||||||
Nausea | 0/10 (0%) | 0/8 (0%) | 2/13 (15.4%) | |||
Vomiting | 0/10 (0%) | 0/8 (0%) | 2/13 (15.4%) | |||
Colitis | 0/10 (0%) | 0/8 (0%) | 1/13 (7.7%) | |||
Hiatus hernia | 0/10 (0%) | 0/8 (0%) | 1/13 (7.7%) | |||
General disorders | ||||||
Oedema peripheral | 0/10 (0%) | 0/8 (0%) | 1/13 (7.7%) | |||
Infections and infestations | ||||||
Nasopharyngitis | 2/10 (20%) | 0/8 (0%) | 1/13 (7.7%) | |||
Upper respiratory tract infection | 1/10 (10%) | 0/8 (0%) | 1/13 (7.7%) | |||
Urinary tract infection | 1/10 (10%) | 0/8 (0%) | 1/13 (7.7%) | |||
Bronchitis | 1/10 (10%) | 0/8 (0%) | 0/13 (0%) | |||
Pneumonia | 0/10 (0%) | 0/8 (0%) | 1/13 (7.7%) | |||
Sepsis | 0/10 (0%) | 0/8 (0%) | 1/13 (7.7%) | |||
Injury, poisoning and procedural complications | ||||||
Contusion | 1/10 (10%) | 0/8 (0%) | 0/13 (0%) | |||
Fall | 1/10 (10%) | 0/8 (0%) | 0/13 (0%) | |||
Foot fracture | 0/10 (0%) | 1/8 (12.5%) | 0/13 (0%) | |||
Investigations | ||||||
Intraocular pressure increased | 2/10 (20%) | 3/8 (37.5%) | 4/13 (30.8%) | |||
Medication residue present | 0/10 (0%) | 1/8 (12.5%) | 0/13 (0%) | |||
Blood creatinine increased | 0/10 (0%) | 0/8 (0%) | 2/13 (15.4%) | |||
Alanine aminotransferase increased | 1/10 (10%) | 0/8 (0%) | 0/13 (0%) | |||
Aspartate aminotransferase increased | 1/10 (10%) | 0/8 (0%) | 0/13 (0%) | |||
Blood potassium increased | 0/10 (0%) | 0/8 (0%) | 2/13 (15.4%) | |||
Gamma-glutamyltransferase increased | 1/10 (10%) | 0/8 (0%) | 0/13 (0%) | |||
Blood alkaline phosphatase increased | 1/10 (10%) | 0/8 (0%) | 0/13 (0%) | |||
Blood cholesterol increased | 0/10 (0%) | 0/8 (0%) | 1/13 (7.7%) | |||
Blood urea increased | 0/10 (0%) | 0/8 (0%) | 1/13 (7.7%) | |||
Cardiac murmur | 1/10 (10%) | 0/8 (0%) | 0/13 (0%) | |||
Haemoglobin decreased | 0/10 (0%) | 0/8 (0%) | 1/13 (7.7%) | |||
Heart rate irregular | 1/10 (10%) | 0/8 (0%) | 0/13 (0%) | |||
Metabolism and nutrition disorders | ||||||
Dehydration | 1/10 (10%) | 0/8 (0%) | 0/13 (0%) | |||
Diabetes mellitus inadequate control | 0/10 (0%) | 0/8 (0%) | 1/13 (7.7%) | |||
Hypokalaemia | 0/10 (0%) | 0/8 (0%) | 1/13 (7.7%) | |||
Musculoskeletal and connective tissue disorders | ||||||
Arthralgia | 0/10 (0%) | 1/8 (12.5%) | 1/13 (7.7%) | |||
Back pain | 0/10 (0%) | 0/8 (0%) | 2/13 (15.4%) | |||
Nervous system disorders | ||||||
Carotid artery stenosis | 0/10 (0%) | 0/8 (0%) | 1/13 (7.7%) | |||
Dementia | 0/10 (0%) | 0/8 (0%) | 1/13 (7.7%) | |||
Transient ischaemic attack | 0/10 (0%) | 0/8 (0%) | 1/13 (7.7%) | |||
Renal and urinary disorders | ||||||
Glycosuria | 0/10 (0%) | 0/8 (0%) | 1/13 (7.7%) | |||
Nephropathy | 0/10 (0%) | 0/8 (0%) | 1/13 (7.7%) | |||
Renal artery occlusion | 0/10 (0%) | 0/8 (0%) | 1/13 (7.7%) | |||
Urine abnormality | 0/10 (0%) | 1/8 (12.5%) | 0/13 (0%) | |||
Respiratory, thoracic and mediastinal disorders | ||||||
Sinus pain | 0/10 (0%) | 0/8 (0%) | 1/13 (7.7%) | |||
Vascular disorders | ||||||
Hypertension | 1/10 (10%) | 1/8 (12.5%) | 3/13 (23.1%) | |||
Hypotension | 0/10 (0%) | 0/8 (0%) | 1/13 (7.7%) | |||
Peripheral arterial occlusive disease | 0/10 (0%) | 0/8 (0%) | 1/13 (7.7%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Dr. Carl Brown |
---|---|
Organization | Taiwan Liposome Company |
Phone | 886-2-2655-7377 |
tlc_clinicaltrials@tlcbio.com |
- TLC399A2002