Macula Edema, Retinal Vein Occlusion
Conditions
Brief summary
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.
Interventions
DRUGTLC399 (ProDex)
2-vial system: TLC399-DSP and TLC399-Lipid
Sponsors
Taiwan Liposome Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. male or female, at least 18 years of age 2. macular edema due to CRVO or BRVO 3. best-corrected visual acuity (BCVA) score of 20/40 to 20/400 4. mean central subfield thickness (CST) ≥350 um 5. willing and able to comply with the study procedure and sign a written informed consent 6. agree to use a medically acceptable form of birth control
Exclusion criteria
1. poorly controlled diabetes 2. history of significant intraocular pressure (IOP) elevation to steroid treatment 3. history of ocular hypertension and glaucoma 4. cataract surgery in the study eye within 3 months, or intraocular surgery within 6 months prior to screening 5. use of hemodilution for the treatment of RVO 6. 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 7. IVT Ozurdex to the study eye within 6 months prior to screening 8. prior use of Retisert or Iluvien 9. use of systemic steroids or heparin within 1 month prior to screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1 TLC399 (ProDex) 0.36mg DSP with 100 mM PL
TLC399 (ProDex): 2-vial system: TLC399-DSP and TLC399-Lipid | 10 |
| Group 2 TLC399 (ProDex) 0.6 mg DSP with 100 mM PL
TLC399 (ProDex): 2-vial system: TLC399-DSP and TLC399-Lipid | 10 |
| Group 3 TLC399 (ProDex) 0.6 mg DSP with 50 mM PL
TLC399 (ProDex): 2-vial system: TLC399-DSP and TLC399-Lipid | 11 |
| Total | 31 |
Baseline characteristics
| Characteristic | Group 1 | Group 2 | Group 3 | Total |
|---|---|---|---|---|
| Age, Continuous | 72.1 years STANDARD_DEVIATION 10.4 | 63.5 years STANDARD_DEVIATION 12.55 | 68.5 years STANDARD_DEVIATION 8.2 | 68.1 years STANDARD_DEVIATION 10.7 |
| BCVA (study eye) | 61.5 letters STANDARD_DEVIATION 7.4 | 48.2 letters STANDARD_DEVIATION 16.94 | 51.1 letters STANDARD_DEVIATION 16.66 | 53.5 letters STANDARD_DEVIATION 15.1 |
| CST (study eye) | 530.6 µm STANDARD_DEVIATION 133.56 | 776.9 µm STANDARD_DEVIATION 288.67 | 702.1 µm STANDARD_DEVIATION 195.15 | 670.9 µm STANDARD_DEVIATION 231.75 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 3 Participants | 2 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants | 7 Participants | 8 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| IOP (study eye) | 12.4 mmHg STANDARD_DEVIATION 2.63 | 13.5 mmHg STANDARD_DEVIATION 3.41 | 13.6 mmHg STANDARD_DEVIATION 2.69 | 13.2 mmHg STANDARD_DEVIATION 2.88 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 9 Participants | 9 Participants | 27 Participants |
| Region of Enrollment United States | 10 participants | 10 participants | 11 participants | 31 participants |
| RVO Type BRVO | 7 Participants | 6 Participants | 7 Participants | 20 Participants |
| RVO Type CRVO | 3 Participants | 4 Participants | 4 Participants | 11 Participants |
| Sex: Female, Male Female | 3 Participants | 4 Participants | 1 Participants | 8 Participants |
| Sex: Female, Male Male | 7 Participants | 6 Participants | 10 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 8 | 0 / 13 |
| other Total, other adverse events | 10 / 10 | 8 / 8 | 13 / 13 |
| serious Total, serious adverse events | 0 / 10 | 2 / 8 | 1 / 13 |
Outcome results
Primary
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.
Time frame: 6 months after dosing
Population: The analysis population was based on subject's randomized treatment group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 | Proportion of Subjects With BCVA Gain of 15 or More Letters From Baseline in the Study Eye | 1 Participants |
| Group 2 | Proportion of Subjects With BCVA Gain of 15 or More Letters From Baseline in the Study Eye | 1 Participants |
| Group 3 | Proportion of Subjects With BCVA Gain of 15 or More Letters From Baseline in the Study Eye | 1 Participants |