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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02980874




Registration number
NCT02980874
Ethics application status
Date submitted
30/11/2016
Date registered
2/12/2016

Titles & IDs
Public title
Suprachoroidal Injection of Triamcinolone Acetonide With IVT Aflibercept in Subjects With Macular Edema Following RVO
Scientific title
SAPPHIRE: A Randomized, Masked, Controlled Trial To Study The Safety And Efficacy Of Suprachoroidal CLS-TA In Conjunction With Intravitreal Aflibercept In Subjects With Retinal Vein Occlusion
Secondary ID [1] 0 0
CLS1003-301
Universal Trial Number (UTN)
Trial acronym
SAPPHIRE
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 - IVT aflibercept

Experimental: Active - IVT aflibercept (2 mg/0.05 mL) + CLS-TA (4 mg/100 µL) SC injections

Active comparator: Control - IVT aflibercept (2 mg/0.05 mL) + sham SC procedure


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

Treatment: Drugs: suprachoroidal sham
suprachoroidal sham procedure

Treatment: Drugs: IVT aflibercept
2 mg intravitreal injection of aflibercept
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
31/01/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/12/2018
Sample size
Target
Accrual to date
Final
460
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Strathfield Retina Clinic - Strathfield
Recruitment hospital [2] 0 0
Save Site Institute, University of Sydney, Sydney Eye Hospital - Sydney
Recruitment hospital [3] 0 0
Sydney Retina Clinic and Day Surgery - Sydney
Recruitment hospital [4] 0 0
Marsden Eye Specialists - Sydney
Recruitment hospital [5] 0 0
The Royal Victorian Eye and Ear Hospital - East Melbourne
Recruitment hospital [6] 0 0
Specialist Eye Group - Melbourne
Recruitment postcode(s) [1] 0 0
2135 - Strathfield
Recruitment postcode(s) [2] 0 0
2000 - Sydney
Recruitment postcode(s) [3] 0 0
2150 - Sydney
Recruitment postcode(s) [4] 0 0
3002 - East Melbourne
Recruitment postcode(s) [5] 0 0
3150 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
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California
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United States of America
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Colorado
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United States of America
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Connecticut
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Florida
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Georgia
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Hawaii
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United States of America
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Illinois
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Indiana
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Kansas
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Kentucky
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Maryland
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Missouri
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New Jersey
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North Carolina
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Ohio
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Oregon
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Pennsylvania
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South Dakota
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Texas
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Utah
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Virginia
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Wisconsin
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Austria
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Graz
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Austria
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Linz
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Canada
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British Columbia
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Canada
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Ontario
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Canada
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Quebec
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Glostrup
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Denmark
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Roskilde
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Pecs
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India
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Gujarat
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India
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Maharashtra
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India
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New Delhi
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India
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Tamil Nadu
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India
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Telangana
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India
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West Bengal
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Israel
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Haifa
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Italy
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Milan
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Philippines
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Cebu City
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Philippines
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Makati City
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Philippines
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Pasig City
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Poland
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Bydgoszcz
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Poland
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Gdansk
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Poland
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Lublin
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Poland
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Olsztyn
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Portugal
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Braga
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Portugal
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Coimbra
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Portugal
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Porto
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Slovakia
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Žilina
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Spain
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Vizcaya
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Oviedo
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Spain
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Pamplona
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Spain
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Zaragoza
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Taiwan
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Kaohsiung
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Taiwan
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Taipei
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United Kingdom
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Belfast
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United Kingdom
State/province [62] 0 0
Sunderland

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 MBA
Address 0 0
Clearside Biomedical, Inc.
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/NCT02980874