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Suprachoroidal Injection of Triamcinolone Acetonide in Subjects With Macular Edema Following Non-Infectious Uveitis (DOGWOOD)

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ClinicalTrials.gov Identifier: NCT02255032
Recruitment Status : Completed
First Posted : October 2, 2014
Results First Posted : February 8, 2021
Last Update Posted : February 8, 2021
Sponsor:
Information provided by (Responsible Party):
Clearside Biomedical, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Uveitis
Macular Edema
Uveitis, Posterior
Uveitis, Anterior
Panuveitis
Uveitis, Intermediate
Interventions Drug: 4 mg CLS-TA
Drug: 0.8 mg CLS-TA
Enrollment 22
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 4 mg CLS-TA 0.8 mg CLS-TA
Hide Arm/Group Description

Single unilateral, suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA

4 mg CLS-TA: 4 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension)

Single unilateral, suprachoroidal injection of 8 mg/mL (0.8 mg in 100 µL) of CLS-TA

0.8 mg CLS-TA: 0.8 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension)

Period Title: Overall Study
Started 17 5
Completed 17 5
Not Completed 0 0
Arm/Group Title 4 mg CLS-TA 0.8 mg CLS-TA Total
Hide Arm/Group Description

Single unilateral, suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA

4 mg CLS-TA: 4 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension)

Single unilateral, suprachoroidal injection of 8 mg/mL (0.8 mg in 100 µL) of CLS-TA

0.8 mg CLS-TA: 0.8 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension)

Total of all reporting groups
Overall Number of Baseline Participants 17 5 22
Hide Baseline Analysis Population Description
Intent-to-Treat set includes all randomly assigned subjects who received at least one dose of study drug.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 5 participants 22 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
13
  76.5%
4
  80.0%
17
  77.3%
>=65 years
4
  23.5%
1
  20.0%
5
  22.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 5 participants 22 participants
52.2  (19.65) 51.8  (16.87) 52.1  (18.67)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 5 participants 22 participants
Female
8
  47.1%
4
  80.0%
12
  54.5%
Male
9
  52.9%
1
  20.0%
10
  45.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 17 participants 5 participants 22 participants
17 5 22
1.Primary Outcome
Title Change From Baseline in Central Subfield Thickness, Measured Using Optical Coherence Tomography, After Treatment With CLS-TA in Subjects With Macular Edema Following Uveitis
Hide Description [Not Specified]
Time Frame 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat set includes all randomly assigned subjects who received at least one dose of study drug.
Arm/Group Title 4 mg CLS-TA 0.8 mg CLS-TA
Hide Arm/Group Description:

Single unilateral, suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA

4 mg CLS-TA: 4 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension)

Single unilateral, suprachoroidal injection of 8 mg/mL (0.8 mg in 100 µL) of CLS-TA

0.8 mg CLS-TA: 0.8 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension)

Overall Number of Participants Analyzed 16 5
Mean (Standard Deviation)
Unit of Measure: Microns
-164.44  (173.148) -78.20  (121.890)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 4 mg CLS-TA
Comments

A paired t-test was used to assess the statistical significance of the change between Baseline and Month 2.

A sample size of 16 subjects would have 80% power to detect a difference of 75, assuming a standard deviation of 100, using a paired t-test with a 0.050 two-sided significance level.

Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0017
Comments The primary analysis of the primary efficacy endpoint was the comparison between the Baseline and Month 2 values for the 4 mg treatment group. No adjustments for multiplicity were necessary.
Method Paired t-test, two-sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -164.44
Confidence Interval (2-Sided) 95%
-256.7 to -72.2
Parameter Dispersion
Type: Standard Deviation
Value: 173.148
Estimation Comments [Not Specified]
Time Frame 8 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 4 mg CLS-TA 0.8 mg CLS-TA
Hide Arm/Group Description

Single unilateral, suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA

4 mg CLS-TA: 4 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension)

Single unilateral, suprachoroidal injection of 8 mg/mL (0.8 mg in 100 µL) of CLS-TA

0.8 mg CLS-TA: 0.8 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension)

All-Cause Mortality
4 mg CLS-TA 0.8 mg CLS-TA
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)      0/5 (0.00%)    
Hide Serious Adverse Events
4 mg CLS-TA 0.8 mg CLS-TA
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/17 (5.88%)      0/5 (0.00%)    
Cardiac disorders     
Atrial fibrillation * 1  1/17 (5.88%)  1 0/5 (0.00%)  0
1
Term from vocabulary, MedDRA (17.0)
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
4 mg CLS-TA 0.8 mg CLS-TA
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/17 (82.35%)      5/5 (100.00%)    
Cardiac disorders     
Palpitations * 1  1/17 (5.88%)  1 0/5 (0.00%)  0
Eye disorders     
Anterior chamber cell * 1 [1]  1/17 (5.88%)  1 0/5 (0.00%)  0
Anterior chamber inflammation * 1 [2]  0/17 (0.00%)  0 1/5 (20.00%)  1
Blindness transient * 1 [2]  0/17 (0.00%)  0 1/5 (20.00%)  1
Conjunctival haemorrhage * 1 [2]  1/17 (5.88%)  1 2/5 (40.00%)  2
Conjunctival haemorrhage * 1 [1]  1/17 (5.88%)  1 0/5 (0.00%)  0
Conjunctival oedema * 1 [2]  1/17 (5.88%)  1 0/5 (0.00%)  0
Dry eye * 1 [2]  1/17 (5.88%)  1 0/5 (0.00%)  0
Dry eye * 1 [1]  1/17 (5.88%)  1 0/5 (0.00%)  0
Eye pain * 1 [2]  3/17 (17.65%)  3 0/5 (0.00%)  0
Foreign body sensation in eyes * 1 [1]  1/17 (5.88%)  1 0/5 (0.00%)  0
Keratitis * 1 [1]  1/17 (5.88%)  1 0/5 (0.00%)  0
Macular oedema * 1 [2]  0/17 (0.00%)  0 3/5 (60.00%)  3
Macular oedema * 1 [1]  2/17 (11.76%)  2 1/5 (20.00%)  1
Ocular discomfort * 1 [2]  1/17 (5.88%)  1 0/5 (0.00%)  0
Punctate keratitis * 1 [2]  1/17 (5.88%)  1 0/5 (0.00%)  0
Retinal artery occlusion * 1 [2]  0/17 (0.00%)  0 1/5 (20.00%)  1
Uveitis * 1 [2]  1/17 (5.88%)  1 1/5 (20.00%)  1
Uveitis * 1 [1]  3/17 (17.65%)  3 0/5 (0.00%)  0
Visual acuity reduced * 1 [1]  1/17 (5.88%)  1 0/5 (0.00%)  0
General disorders     
Injection site pain * 1 [2]  1/17 (5.88%)  1 1/5 (20.00%)  1
Papillitis * 1 [2]  1/17 (5.88%)  1 0/5 (0.00%)  0
Papillitis * 1 [1]  1/17 (5.88%)  1 0/5 (0.00%)  0
Infections and infestations     
Bronchitis * 1  1/17 (5.88%)  1 0/5 (0.00%)  0
Gastrointestinal infection * 1  1/17 (5.88%)  1 0/5 (0.00%)  0
Sinusitis * 1  1/17 (5.88%)  1 0/5 (0.00%)  0
Tooth infection * 1  0/17 (0.00%)  0 1/5 (20.00%)  1
Upper respiratory tract infection * 1  0/17 (0.00%)  0 1/5 (20.00%)  1
Injury, poisoning and procedural complications     
Contusion * 1  0/17 (0.00%)  0 1/5 (20.00%)  1
Fall * 1  0/17 (0.00%)  0 1/5 (20.00%)  1
Investigations     
Blood pressure diastolic increased * 1  1/17 (5.88%)  1 0/5 (0.00%)  0
Blood pressure systolic increased * 1  1/17 (5.88%)  1 0/5 (0.00%)  0
Heart rate decreased * 1  1/17 (5.88%)  1 0/5 (0.00%)  0
Intraocular pressure increased * 1 [2]  1/17 (5.88%)  1 0/5 (0.00%)  0
Intraocular pressure increased * 1 [1]  1/17 (5.88%)  1 0/5 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  0/17 (0.00%)  0 1/5 (20.00%)  1
Psychiatric disorders     
Substance-induced psychotic disorder * 1  1/17 (5.88%)  2 0/5 (0.00%)  0
Vascular disorders     
Hypertension * 1  2/17 (11.76%)  2 0/5 (0.00%)  0
1
Term from vocabulary, MedDRA (17.0)
*
Indicates events were collected by non-systematic assessment
[1]
#Fellow eye
[2]
#Study eye
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The institution and investigators participating in this trial shall have no right to publish or present the results of this study without the prior written consent of Clearside.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Thomas Ciulla, MD
Organization: Clearside Biomedical, Inc.
Phone: (678) 392-2318
EMail: thomas.ciulla@clearsidebio.com
Layout table for additonal information
Responsible Party: Clearside Biomedical, Inc.
ClinicalTrials.gov Identifier: NCT02255032    
Other Study ID Numbers: CLS1001-201
First Submitted: September 30, 2014
First Posted: October 2, 2014
Results First Submitted: January 18, 2021
Results First Posted: February 8, 2021
Last Update Posted: February 8, 2021