Register a trial

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
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
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Hawaii
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Kansas
Country [11] 0 0
United States of America
State/province [11] 0 0
Kentucky
Country [12] 0 0
United States of America
State/province [12] 0 0
Maryland
Country [13] 0 0
United States of America
State/province [13] 0 0
Missouri
Country [14] 0 0
United States of America
State/province [14] 0 0
New Jersey
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Oregon
Country [18] 0 0
United States of America
State/province [18] 0 0
Pennsylvania
Country [19] 0 0
United States of America
State/province [19] 0 0
South Dakota
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
United States of America
State/province [21] 0 0
Utah
Country [22] 0 0
United States of America
State/province [22] 0 0
Virginia
Country [23] 0 0
United States of America
State/province [23] 0 0
Wisconsin
Country [24] 0 0
Austria
State/province [24] 0 0
Graz
Country [25] 0 0
Austria
State/province [25] 0 0
Linz
Country [26] 0 0
Canada
State/province [26] 0 0
British Columbia
Country [27] 0 0
Canada
State/province [27] 0 0
Ontario
Country [28] 0 0
Canada
State/province [28] 0 0
Quebec
Country [29] 0 0
Denmark
State/province [29] 0 0
Glostrup
Country [30] 0 0
Denmark
State/province [30] 0 0
Roskilde
Country [31] 0 0
Hungary
State/province [31] 0 0
Budapest
Country [32] 0 0
Hungary
State/province [32] 0 0
Debrecen
Country [33] 0 0
Hungary
State/province [33] 0 0
Pecs
Country [34] 0 0
India
State/province [34] 0 0
Gujarat
Country [35] 0 0
India
State/province [35] 0 0
Maharashtra
Country [36] 0 0
India
State/province [36] 0 0
New Delhi
Country [37] 0 0
India
State/province [37] 0 0
Tamil Nadu
Country [38] 0 0
India
State/province [38] 0 0
Telangana
Country [39] 0 0
India
State/province [39] 0 0
West Bengal
Country [40] 0 0
Israel
State/province [40] 0 0
Haifa
Country [41] 0 0
Italy
State/province [41] 0 0
Milan
Country [42] 0 0
Philippines
State/province [42] 0 0
Cebu City
Country [43] 0 0
Philippines
State/province [43] 0 0
Makati City
Country [44] 0 0
Philippines
State/province [44] 0 0
Pasig City
Country [45] 0 0
Poland
State/province [45] 0 0
Bydgoszcz
Country [46] 0 0
Poland
State/province [46] 0 0
Gdansk
Country [47] 0 0
Poland
State/province [47] 0 0
Lublin
Country [48] 0 0
Poland
State/province [48] 0 0
Olsztyn
Country [49] 0 0
Portugal
State/province [49] 0 0
Braga
Country [50] 0 0
Portugal
State/province [50] 0 0
Coimbra
Country [51] 0 0
Portugal
State/province [51] 0 0
Porto
Country [52] 0 0
Slovakia
State/province [52] 0 0
Žilina
Country [53] 0 0
Spain
State/province [53] 0 0
Vizcaya
Country [54] 0 0
Spain
State/province [54] 0 0
Barcelona
Country [55] 0 0
Spain
State/province [55] 0 0
Madrid
Country [56] 0 0
Spain
State/province [56] 0 0
Oviedo
Country [57] 0 0
Spain
State/province [57] 0 0
Pamplona
Country [58] 0 0
Spain
State/province [58] 0 0
Zaragoza
Country [59] 0 0
Taiwan
State/province [59] 0 0
Kaohsiung
Country [60] 0 0
Taiwan
State/province [60] 0 0
Taipei
Country [61] 0 0
United Kingdom
State/province [61] 0 0
Belfast
Country [62] 0 0
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