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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03203447




Registration number
NCT03203447
Ethics application status
Date submitted
28/06/2017
Date registered
29/06/2017

Titles & IDs
Public title
Suprachoroidal Injection of Triamcinolone Acetonide With IVT Anti-VEGF in Subjects With Macular Edema Following RVO
Scientific title
A Randomized, Masked, Controlled Trial To Study The Safety And Efficacy Of Suprachoroidal CLS-TA In Combination With An Intravitreal Anti-VEGF Agent In Subjects With Retinal Vein Occlusion
Secondary ID [1] 0 0
CLS1003-302
Universal Trial Number (UTN)
Trial acronym
TOPAZ
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Macular Edema 0 0
Retinal Vein Occlusion 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - suprachoroidal CLS-TA
Treatment: Drugs - suprachoroidal sham
Treatment: Drugs - Lucentis or Avastin

Active comparator: Active - Lucentis (0.5 mg/0.05 mL), IVT injection + CLS-TA (4 mg/0.10 mL), SC injection or Avastin (1.25 mg/0.05 mL), IVT injection + CLS-TA (4 mg/0.10 mL), SC injection

Sham comparator: Control - Lucentis (0.5 mg/0.05 mL), IVT injection + sham SC procedure or Avastin (1.25 mg/0.05 mL), IVT injection + sham SC procedure


Treatment: Drugs: suprachoroidal CLS-TA
suprachoroidal injection of CLS-TA

Treatment: Drugs: suprachoroidal sham
sham suprachoroidal procedure

Treatment: Drugs: Lucentis or Avastin
IVT anti-VEGF agent. Either a 0.5 mg intravitreal injection of Lucentis or 1.25 mg intravitreal injection of Avastin
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of Subjects Demonstrating = 15 Letter Improvement From Baseline in Early Treatment of Diabetic Retinopathy Study (ETDRS)
Timepoint [1] 0 0
2 months
Secondary outcome [1] 0 0
Mean Change From Baseline in Best Corrected Visual Acuity
Timepoint [1] 0 0
6 months
Secondary outcome [2] 0 0
Mean Change From Baseline in Central Subfield Thickness
Timepoint [2] 0 0
6 months

Eligibility
Key inclusion criteria
* Has a clinical diagnosis of RVO in the study eye
* Has a CST of = 300 µm in the study eye
* Has an ETDRS BCVA score of = 20 letters read and = 70 letters read in the study eye
* Is naïve to local pharmacologic treatment for RVO in the study eye
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Any active ocular disease or infection in the study eye other than RVO
* History of glaucoma, intraocular pressure > 21 mmHg or ocular hypertension requiring more than one medication
* Any uncontrolled systemic disease that, in the opinion of the Investigator, would preclude participation in the study
* Any evidence of neovascularization in the study eye

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/03/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/12/2018
Sample size
Target
Accrual to date
Final
325
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Eye Clinic Albury Wodonga - Albury
Recruitment hospital [2] 0 0
Strathfield Retina Clinic - Strathfield
Recruitment hospital [3] 0 0
Save Sight Institute, University of Sydney (Sydney Eye Hospital) - Sydney
Recruitment postcode(s) [1] 0 0
2640 - Albury
Recruitment postcode(s) [2] 0 0
2135 - Strathfield
Recruitment postcode(s) [3] 0 0
2000 - Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Hawaii
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
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United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Missouri
Country [13] 0 0
United States of America
State/province [13] 0 0
Nevada
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
Ohio
Country [16] 0 0
United States of America
State/province [16] 0 0
Oklahoma
Country [17] 0 0
United States of America
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Pennsylvania
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United States of America
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South Dakota
Country [19] 0 0
United States of America
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Texas
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United States of America
State/province [20] 0 0
Utah
Country [21] 0 0
United States of America
State/province [21] 0 0
Virginia
Country [22] 0 0
United States of America
State/province [22] 0 0
West Virginia
Country [23] 0 0
Hungary
State/province [23] 0 0
Budapest
Country [24] 0 0
India
State/province [24] 0 0
Ahmedabad
Country [25] 0 0
India
State/province [25] 0 0
Andhra Pradesh
Country [26] 0 0
India
State/province [26] 0 0
Ansari Nagar
Country [27] 0 0
India
State/province [27] 0 0
Bangalaore
Country [28] 0 0
India
State/province [28] 0 0
Bhubaneswar
Country [29] 0 0
India
State/province [29] 0 0
Gujarat
Country [30] 0 0
India
State/province [30] 0 0
Maharashtra
Country [31] 0 0
India
State/province [31] 0 0
New Delhi
Country [32] 0 0
India
State/province [32] 0 0
Patna
Country [33] 0 0
India
State/province [33] 0 0
Raghunathpur
Country [34] 0 0
India
State/province [34] 0 0
Rajasthan
Country [35] 0 0
India
State/province [35] 0 0
Tamil Nadu
Country [36] 0 0
India
State/province [36] 0 0
Uttar Pradesh
Country [37] 0 0
India
State/province [37] 0 0
West Bengal
Country [38] 0 0
New Zealand
State/province [38] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Clearside Biomedical, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Thomas Ciulla, MD
Address 0 0
Chief Medical Officer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03203447