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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02980874
Ethics application status
Date submitted
30/11/2016
Date registered
2/12/2016
Date last updated
20/12/2019

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) - Based on best corrected visual acuity
Timepoint [1] 0 0
2 months
Secondary outcome [1] 0 0
Mean change from baseline in best corrected visual acuity - Based on ETDRS
Timepoint [1] 0 0
6 months
Secondary outcome [2] 0 0
Mean change from baseline in central subfield thickness - Based on spectral domain optical coherence tomography
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
Gender
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
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
State/province [2] 0 0
California
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United States of America
State/province [3] 0 0
Colorado
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United States of America
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Connecticut
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United States of America
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Florida
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Georgia
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United States of America
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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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United States of America
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Kentucky
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Maryland
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United States of America
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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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United States of America
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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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Denmark
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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
This is a Phase 3, multicenter, randomized, masked, controlled, parallel group study of 12
months duration in treatment naïve subjects with RVO.
Trial website
https://clinicaltrials.gov/show/NCT02980874
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Thomas Ciulla, MD
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

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02980874