Register a trial

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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/NCT01940887




Registration number
NCT01940887
Ethics application status
Date submitted
9/09/2013
Date registered
12/09/2013

Titles & IDs
Public title
A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Either Avastin® or Eylea® Compared to Avastin® or Eylea® Monotherapy
Scientific title
A Phase 3 Randomized, Double-masked, Controlled Trial to Establish the Safety and Efficacy of Intravitreous Administration of Fovista® (Anti PDGF-B Pegylated Aptamer) Administered in Combination With Either Avastin® or Eylea® Compared to Avastin® or Eylea® Monotherapy in Subjects With Subfoveal Neovascular Age-related Macular Degeneration.
Secondary ID [1] 0 0
OPH1004
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Age-Related Macular Degeneration 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - bevacizumab or aflibercept
Treatment: Drugs - E10030 sham injection

Experimental: E10030 + bevacizumab or aflibercept - E10030 1.5 mg intravitreal injection + bevacizumab 1.25 mg intravitreal injection or aflibercept 2 mg intravitreal injection

Active comparator: Sham + bevacizumab or aflibercept - E10030 sham injection + bevacizumab 1.25 mg intravitreal injection or aflibercept 2 mg intravitreal injection


Treatment: Drugs: bevacizumab or aflibercept
Patients are randomized to receive either bevacizumab or aflibercept

Treatment: Drugs: E10030 sham injection
Pressure on the eye with a syringe with no needle
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean Change in Visual Acuity (Measured at Baseline and at the Month 12 Visit)
Timepoint [1] 0 0
12 months

Eligibility
Key inclusion criteria
* Subjects of either gender aged = 50 years
* Active subfoveal choroidal neovascularization (CNV) secondary to AMD
* Presence of sub-retinal hyper-reflective material (SD-OCT)
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Any prior treatment for AMD in the study eye prior to the Day 1 visit, except oral supplements of vitamins and minerals
* Any prior intravitreal treatment in the study eye prior to the Day 1 visit, regardless of indication (including intravitreal corticosteroids)
* Any intraocular surgery or thermal laser within three (3) months of trial entry. Any prior thermal laser in the macular region, regardless of indication
* Subjects with subfoveal scar or subfoveal atrophy are excluded
* Diabetes mellitus

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
The people analysing the results/data
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
1/05/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2017
Sample size
Target
Accrual to date
Final
645
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
- Albury
Recruitment hospital [2] 0 0
- Parramatta
Recruitment hospital [3] 0 0
- Sydney
Recruitment hospital [4] 0 0
- Westmead
Recruitment hospital [5] 0 0
- East Melbourne
Recruitment postcode(s) [1] 0 0
2640 - Albury
Recruitment postcode(s) [2] 0 0
2150 - Parramatta
Recruitment postcode(s) [3] 0 0
2000 - Sydney
Recruitment postcode(s) [4] 0 0
2145 - Westmead
Recruitment postcode(s) [5] 0 0
3002 - East 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
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Iowa
Country [9] 0 0
United States of America
State/province [9] 0 0
Kansas
Country [10] 0 0
United States of America
State/province [10] 0 0
Kentucky
Country [11] 0 0
United States of America
State/province [11] 0 0
Maryland
Country [12] 0 0
United States of America
State/province [12] 0 0
Massachusetts
Country [13] 0 0
United States of America
State/province [13] 0 0
Michigan
Country [14] 0 0
United States of America
State/province [14] 0 0
Minnesota
Country [15] 0 0
United States of America
State/province [15] 0 0
Missouri
Country [16] 0 0
United States of America
State/province [16] 0 0
Nebraska
Country [17] 0 0
United States of America
State/province [17] 0 0
Nevada
Country [18] 0 0
United States of America
State/province [18] 0 0
New Jersey
Country [19] 0 0
United States of America
State/province [19] 0 0
New Mexico
Country [20] 0 0
United States of America
State/province [20] 0 0
New York
Country [21] 0 0
United States of America
State/province [21] 0 0
North Carolina
Country [22] 0 0
United States of America
State/province [22] 0 0
Ohio
Country [23] 0 0
United States of America
State/province [23] 0 0
Oklahoma
Country [24] 0 0
United States of America
State/province [24] 0 0
Oregon
Country [25] 0 0
United States of America
State/province [25] 0 0
Pennsylvania
Country [26] 0 0
United States of America
State/province [26] 0 0
South Carolina
Country [27] 0 0
United States of America
State/province [27] 0 0
South Dakota
Country [28] 0 0
United States of America
State/province [28] 0 0
Texas
Country [29] 0 0
United States of America
State/province [29] 0 0
Utah
Country [30] 0 0
United States of America
State/province [30] 0 0
Virginia
Country [31] 0 0
United States of America
State/province [31] 0 0
Washington
Country [32] 0 0
United States of America
State/province [32] 0 0
West Virginia
Country [33] 0 0
Argentina
State/province [33] 0 0
Buenos Aires
Country [34] 0 0
Argentina
State/province [34] 0 0
Cordoba
Country [35] 0 0
Argentina
State/province [35] 0 0
Santa Fe
Country [36] 0 0
Austria
State/province [36] 0 0
Graz
Country [37] 0 0
Brazil
State/province [37] 0 0
Goiânia
Country [38] 0 0
Brazil
State/province [38] 0 0
São Paulo
Country [39] 0 0
Canada
State/province [39] 0 0
British Columbia
Country [40] 0 0
Canada
State/province [40] 0 0
Manitoba
Country [41] 0 0
Canada
State/province [41] 0 0
Ontario
Country [42] 0 0
Canada
State/province [42] 0 0
Quebec
Country [43] 0 0
Colombia
State/province [43] 0 0
Bogota
Country [44] 0 0
Colombia
State/province [44] 0 0
Medellin
Country [45] 0 0
Croatia
State/province [45] 0 0
Osijek
Country [46] 0 0
Croatia
State/province [46] 0 0
Rijeka
Country [47] 0 0
Croatia
State/province [47] 0 0
Zagreb
Country [48] 0 0
Czechia
State/province [48] 0 0
Brno
Country [49] 0 0
Czechia
State/province [49] 0 0
Hradec Kralove
Country [50] 0 0
Czechia
State/province [50] 0 0
Olomouc
Country [51] 0 0
Czechia
State/province [51] 0 0
Prague
Country [52] 0 0
Czechia
State/province [52] 0 0
Praha
Country [53] 0 0
Estonia
State/province [53] 0 0
Tallinn
Country [54] 0 0
Finland
State/province [54] 0 0
Helsinki
Country [55] 0 0
Finland
State/province [55] 0 0
Kuopio
Country [56] 0 0
France
State/province [56] 0 0
Creteil
Country [57] 0 0
France
State/province [57] 0 0
Lyon
Country [58] 0 0
France
State/province [58] 0 0
Marseille
Country [59] 0 0
France
State/province [59] 0 0
Paris
Country [60] 0 0
France
State/province [60] 0 0
Rouen
Country [61] 0 0
France
State/province [61] 0 0
Strasbourg
Country [62] 0 0
France
State/province [62] 0 0
Tours
Country [63] 0 0
Germany
State/province [63] 0 0
Nordrhein-Westfalen
Country [64] 0 0
Germany
State/province [64] 0 0
Norhdhein-Westfalen
Country [65] 0 0
Germany
State/province [65] 0 0
Sachsen
Country [66] 0 0
Germany
State/province [66] 0 0
Schleswig-Holstein
Country [67] 0 0
Germany
State/province [67] 0 0
Göttingen
Country [68] 0 0
Germany
State/province [68] 0 0
Hamburg
Country [69] 0 0
Germany
State/province [69] 0 0
Karlsruhe
Country [70] 0 0
Germany
State/province [70] 0 0
Lübeck
Country [71] 0 0
Germany
State/province [71] 0 0
Mainz
Country [72] 0 0
Germany
State/province [72] 0 0
Tübingen
Country [73] 0 0
Hungary
State/province [73] 0 0
Budapest
Country [74] 0 0
Hungary
State/province [74] 0 0
Debrecen
Country [75] 0 0
Hungary
State/province [75] 0 0
Pecs
Country [76] 0 0
Hungary
State/province [76] 0 0
Szeged
Country [77] 0 0
Hungary
State/province [77] 0 0
Veszprem
Country [78] 0 0
Israel
State/province [78] 0 0
Haifa
Country [79] 0 0
Israel
State/province [79] 0 0
Jerusalem
Country [80] 0 0
Israel
State/province [80] 0 0
Kfar Saba
Country [81] 0 0
Israel
State/province [81] 0 0
Pita Tikva
Country [82] 0 0
Israel
State/province [82] 0 0
Rehovot
Country [83] 0 0
Israel
State/province [83] 0 0
Tel Aviv
Country [84] 0 0
Italy
State/province [84] 0 0
Ancona
Country [85] 0 0
Italy
State/province [85] 0 0
Bologna
Country [86] 0 0
Italy
State/province [86] 0 0
Ferrara
Country [87] 0 0
Italy
State/province [87] 0 0
Milano
Country [88] 0 0
Italy
State/province [88] 0 0
Padova
Country [89] 0 0
Italy
State/province [89] 0 0
Roma
Country [90] 0 0
Italy
State/province [90] 0 0
Torino
Country [91] 0 0
Italy
State/province [91] 0 0
Udine
Country [92] 0 0
Latvia
State/province [92] 0 0
Riga
Country [93] 0 0
Norway
State/province [93] 0 0
Stavanger
Country [94] 0 0
Poland
State/province [94] 0 0
Bydgoszcz
Country [95] 0 0
Poland
State/province [95] 0 0
Katowice
Country [96] 0 0
Poland
State/province [96] 0 0
Lodz
Country [97] 0 0
Poland
State/province [97] 0 0
Wroclaw
Country [98] 0 0
Portugal
State/province [98] 0 0
Coimbra
Country [99] 0 0
Portugal
State/province [99] 0 0
Lisboa
Country [100] 0 0
Portugal
State/province [100] 0 0
Porto
Country [101] 0 0
Portugal
State/province [101] 0 0
Vila Franca de Xira
Country [102] 0 0
Slovakia
State/province [102] 0 0
Banska Bystrica
Country [103] 0 0
Slovakia
State/province [103] 0 0
Trencin
Country [104] 0 0
Spain
State/province [104] 0 0
Islas Canarias
Country [105] 0 0
Spain
State/province [105] 0 0
Navarra
Country [106] 0 0
Spain
State/province [106] 0 0
Vizcaya
Country [107] 0 0
Spain
State/province [107] 0 0
A Coruña
Country [108] 0 0
Spain
State/province [108] 0 0
Albacete
Country [109] 0 0
Spain
State/province [109] 0 0
Barcelona
Country [110] 0 0
Spain
State/province [110] 0 0
Oviedo
Country [111] 0 0
Spain
State/province [111] 0 0
Valencia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Ophthotech Corporation
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
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
Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.


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/NCT01940887