Trial Outcomes & Findings for Phase 1 Open-label Study to Evaluate Efficacy and Tolerability of TLC399 in Patients With Macular Edema Due to RVO (NCT NCT02006147)
NCT ID: NCT02006147
Last Updated: 2021-12-23
Results Overview
Ocular AEs
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
14 participants
Primary outcome timeframe
4 weeks
Results posted on
2021-12-23
Participant Flow
Participant milestones
| Measure |
TLC399 (Group 1)
0.36 mg Dexamethasone Sodium Phosphate with 100 mM Phospholipid
|
TLC399 (Group R1)
0.24 mg Dexamethasone Sodium Phosphate with 100 mM Phospholipid
|
TLC399 (Group 2)
0.6 mg Dexamethasone Sodium Phosphate with 100 mM Phospholipid
|
TLC399 (Group 3)
0.6 mg Dexamethasone Sodium Phosphate with 50 mM Phospholipid
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
9
|
0
|
0
|
|
Overall Study
COMPLETED
|
3
|
7
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
0
|
0
|
Reasons for withdrawal
| Measure |
TLC399 (Group 1)
0.36 mg Dexamethasone Sodium Phosphate with 100 mM Phospholipid
|
TLC399 (Group R1)
0.24 mg Dexamethasone Sodium Phosphate with 100 mM Phospholipid
|
TLC399 (Group 2)
0.6 mg Dexamethasone Sodium Phosphate with 100 mM Phospholipid
|
TLC399 (Group 3)
0.6 mg Dexamethasone Sodium Phosphate with 50 mM Phospholipid
|
|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Sponsor
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Phase 1 Open-label Study to Evaluate Efficacy and Tolerability of TLC399 in Patients With Macular Edema Due to RVO
Baseline characteristics by cohort
| Measure |
TLC399 (Group 1)
n=4 Participants
0.36 mg Dexamethasone Sodium Phosphate with 100 mM Phospholipid
|
TLC399 (Group R1)
n=9 Participants
0.24 mg Dexamethasone Sodium Phosphate with 100 mM Phospholipid
|
TLC399 (Group 2)
0.6 mg Dexamethasone Sodium Phosphate with 100 mM Phospholipid
|
TLC399 (Group 3)
0.6 mg Dexamethasone Sodium Phosphate with 50 mM Phospholipid
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
61.8 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
65.8 years
STANDARD_DEVIATION 16.2 • n=7 Participants
|
—
|
—
|
64.5 years
STANDARD_DEVIATION 14.4 • n=21 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
—
|
—
|
8 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
—
|
—
|
5 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
—
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
—
|
—
|
13 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
—
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
—
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
—
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
—
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
—
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
Taiwan
|
4 participants
n=5 Participants
|
9 participants
n=7 Participants
|
—
|
—
|
13 participants
n=21 Participants
|
|
Macular edema by retinal vein occlusion
Branch retinal vein occlusion
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
—
|
—
|
10 Participants
n=21 Participants
|
|
Macular edema by retinal vein occlusion
Central retinal vein occlusion
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
—
|
—
|
3 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 4 weeksOcular AEs
Outcome measures
| Measure |
TLC399 (Group 1)
n=4 Participants
0.36 mg Dexamethasone Sodium Phosphate with 100 mM Phospholipid
|
TLC399 (Group R1)
n=9 Participants
0.24 mg Dexamethasone Sodium Phosphate with 100 mM Phospholipid
|
|---|---|---|
|
Part 1: Dose-limiting Toxicity (DLT)
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 1 yearNumber of SAEs and treatment-related severe AEs
Outcome measures
| Measure |
TLC399 (Group 1)
n=4 Participants
0.36 mg Dexamethasone Sodium Phosphate with 100 mM Phospholipid
|
TLC399 (Group R1)
n=9 Participants
0.24 mg Dexamethasone Sodium Phosphate with 100 mM Phospholipid
|
|---|---|---|
|
Part 2: Safety Assessment: Number of SAEs and Treatment-related Severe AEs
Number of SAE
|
2 Number of events
|
5 Number of events
|
|
Part 2: Safety Assessment: Number of SAEs and Treatment-related Severe AEs
Number of Treatment-related severe AE
|
0 Number of events
|
5 Number of events
|
Adverse Events
TLC399 (Group 1)
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
TLC399 (Group R1)
Serious events: 4 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TLC399 (Group 1)
n=4 participants at risk
0.36 mg Dexamethasone Sodium Phosphate with 100 mM Phospholipid
|
TLC399 (Group R1)
n=9 participants at risk
0.24 mg Dexamethasone Sodium Phosphate with 100 mM Phospholipid
|
|---|---|---|
|
Injury, poisoning and procedural complications
Head Injury With Contusion
|
25.0%
1/4 • 14 days (screeing) + 1 year
|
0.00%
0/9 • 14 days (screeing) + 1 year
|
|
Eye disorders
Ocular Hypertension
|
25.0%
1/4 • 14 days (screeing) + 1 year
|
0.00%
0/9 • 14 days (screeing) + 1 year
|
|
Investigations
Intraocular Pressure Increased
|
0.00%
0/4 • 14 days (screeing) + 1 year
|
11.1%
1/9 • 14 days (screeing) + 1 year
|
|
Eye disorders
Prolong Vitreous Opacity
|
0.00%
0/4 • 14 days (screeing) + 1 year
|
11.1%
1/9 • 14 days (screeing) + 1 year
|
|
Investigations
IOP Elevation
|
0.00%
0/4 • 14 days (screeing) + 1 year
|
11.1%
1/9 • 14 days (screeing) + 1 year
|
|
Eye disorders
More than 30 Letters Visual Acuity Reduction from Baseline of BCVA
|
0.00%
0/4 • 14 days (screeing) + 1 year
|
11.1%
1/9 • 14 days (screeing) + 1 year
|
|
Investigations
Increased Intraocular Pressure
|
0.00%
0/4 • 14 days (screeing) + 1 year
|
11.1%
1/9 • 14 days (screeing) + 1 year
|
Other adverse events
| Measure |
TLC399 (Group 1)
n=4 participants at risk
0.36 mg Dexamethasone Sodium Phosphate with 100 mM Phospholipid
|
TLC399 (Group R1)
n=9 participants at risk
0.24 mg Dexamethasone Sodium Phosphate with 100 mM Phospholipid
|
|---|---|---|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4 • 14 days (screeing) + 1 year
|
11.1%
1/9 • 14 days (screeing) + 1 year
|
|
Investigations
Blood pressure increased
|
0.00%
0/4 • 14 days (screeing) + 1 year
|
11.1%
1/9 • 14 days (screeing) + 1 year
|
|
Investigations
Intraocular pressure decreased
|
0.00%
0/4 • 14 days (screeing) + 1 year
|
11.1%
1/9 • 14 days (screeing) + 1 year
|
|
Investigations
Optic nerve cup/disc ratio increased
|
0.00%
0/4 • 14 days (screeing) + 1 year
|
11.1%
1/9 • 14 days (screeing) + 1 year
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/4 • 14 days (screeing) + 1 year
|
11.1%
1/9 • 14 days (screeing) + 1 year
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
25.0%
1/4 • 14 days (screeing) + 1 year
|
0.00%
0/9 • 14 days (screeing) + 1 year
|
|
Investigations
Intraocular pressure increased
|
0.00%
0/4 • 14 days (screeing) + 1 year
|
55.6%
5/9 • 14 days (screeing) + 1 year
|
|
Investigations
Alanine aminotransferase increase
|
0.00%
0/4 • 14 days (screeing) + 1 year
|
11.1%
1/9 • 14 days (screeing) + 1 year
|
|
Eye disorders
Vitreous opacities
|
100.0%
4/4 • 14 days (screeing) + 1 year
|
66.7%
6/9 • 14 days (screeing) + 1 year
|
|
Eye disorders
Visual acuity reduced
|
50.0%
2/4 • 14 days (screeing) + 1 year
|
55.6%
5/9 • 14 days (screeing) + 1 year
|
|
Eye disorders
Conjunctival haemorrhage
|
50.0%
2/4 • 14 days (screeing) + 1 year
|
22.2%
2/9 • 14 days (screeing) + 1 year
|
|
Eye disorders
Corneal oedema
|
25.0%
1/4 • 14 days (screeing) + 1 year
|
11.1%
1/9 • 14 days (screeing) + 1 year
|
|
Eye disorders
Dry eye
|
0.00%
0/4 • 14 days (screeing) + 1 year
|
22.2%
2/9 • 14 days (screeing) + 1 year
|
|
Eye disorders
Macular oedea
|
0.00%
0/4 • 14 days (screeing) + 1 year
|
22.2%
2/9 • 14 days (screeing) + 1 year
|
|
Eye disorders
Ocular hypertension
|
50.0%
2/4 • 14 days (screeing) + 1 year
|
0.00%
0/9 • 14 days (screeing) + 1 year
|
|
Eye disorders
Retinal thickening
|
25.0%
1/4 • 14 days (screeing) + 1 year
|
11.1%
1/9 • 14 days (screeing) + 1 year
|
|
Eye disorders
Abnormal sensation in eye
|
25.0%
1/4 • 14 days (screeing) + 1 year
|
0.00%
0/9 • 14 days (screeing) + 1 year
|
|
Eye disorders
Cataract
|
0.00%
0/4 • 14 days (screeing) + 1 year
|
11.1%
1/9 • 14 days (screeing) + 1 year
|
|
Eye disorders
Cataract nuclear
|
25.0%
1/4 • 14 days (screeing) + 1 year
|
0.00%
0/9 • 14 days (screeing) + 1 year
|
|
Eye disorders
Conjunctival follicles
|
0.00%
0/4 • 14 days (screeing) + 1 year
|
11.1%
1/9 • 14 days (screeing) + 1 year
|
|
Eye disorders
Conjunctival hyperaemia
|
25.0%
1/4 • 14 days (screeing) + 1 year
|
0.00%
0/9 • 14 days (screeing) + 1 year
|
|
Eye disorders
Eye opacity
|
0.00%
0/4 • 14 days (screeing) + 1 year
|
11.1%
1/9 • 14 days (screeing) + 1 year
|
|
Eye disorders
Foreign body sensation in eyes
|
25.0%
1/4 • 14 days (screeing) + 1 year
|
0.00%
0/9 • 14 days (screeing) + 1 year
|
|
Eye disorders
Hyalosis asteroid
|
0.00%
0/4 • 14 days (screeing) + 1 year
|
11.1%
1/9 • 14 days (screeing) + 1 year
|
|
Eye disorders
Pupillary reflex impaired
|
0.00%
0/4 • 14 days (screeing) + 1 year
|
11.1%
1/9 • 14 days (screeing) + 1 year
|
|
Eye disorders
Retinal disorder
|
0.00%
0/4 • 14 days (screeing) + 1 year
|
11.1%
1/9 • 14 days (screeing) + 1 year
|
|
Eye disorders
Vitreous floaters
|
25.0%
1/4 • 14 days (screeing) + 1 year
|
0.00%
0/9 • 14 days (screeing) + 1 year
|
|
Eye disorders
Vitreous haze
|
0.00%
0/4 • 14 days (screeing) + 1 year
|
11.1%
1/9 • 14 days (screeing) + 1 year
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
1/4 • 14 days (screeing) + 1 year
|
0.00%
0/9 • 14 days (screeing) + 1 year
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • 14 days (screeing) + 1 year
|
0.00%
0/9 • 14 days (screeing) + 1 year
|
|
General disorders
Sensation of foreign body
|
0.00%
0/4 • 14 days (screeing) + 1 year
|
11.1%
1/9 • 14 days (screeing) + 1 year
|
|
Infections and infestations
Nasopharyngitis
|
25.0%
1/4 • 14 days (screeing) + 1 year
|
11.1%
1/9 • 14 days (screeing) + 1 year
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/4 • 14 days (screeing) + 1 year
|
11.1%
1/9 • 14 days (screeing) + 1 year
|
|
Infections and infestations
Vestibular neuronitis
|
0.00%
0/4 • 14 days (screeing) + 1 year
|
11.1%
1/9 • 14 days (screeing) + 1 year
|
|
Injury, poisoning and procedural complications
Contusion
|
25.0%
1/4 • 14 days (screeing) + 1 year
|
11.1%
1/9 • 14 days (screeing) + 1 year
|
|
Injury, poisoning and procedural complications
Head injury
|
25.0%
1/4 • 14 days (screeing) + 1 year
|
0.00%
0/9 • 14 days (screeing) + 1 year
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/4 • 14 days (screeing) + 1 year
|
22.2%
2/9 • 14 days (screeing) + 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • 14 days (screeing) + 1 year
|
22.2%
2/9 • 14 days (screeing) + 1 year
|
|
Nervous system disorders
Visual field defect
|
25.0%
1/4 • 14 days (screeing) + 1 year
|
33.3%
3/9 • 14 days (screeing) + 1 year
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • 14 days (screeing) + 1 year
|
11.1%
1/9 • 14 days (screeing) + 1 year
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • 14 days (screeing) + 1 year
|
11.1%
1/9 • 14 days (screeing) + 1 year
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/4 • 14 days (screeing) + 1 year
|
11.1%
1/9 • 14 days (screeing) + 1 year
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/4 • 14 days (screeing) + 1 year
|
11.1%
1/9 • 14 days (screeing) + 1 year
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.0%
1/4 • 14 days (screeing) + 1 year
|
0.00%
0/9 • 14 days (screeing) + 1 year
|
|
Vascular disorders
Hypertension
|
25.0%
1/4 • 14 days (screeing) + 1 year
|
0.00%
0/9 • 14 days (screeing) + 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place