Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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/NCT02462928




Registration number
NCT02462928
Ethics application status
Date submitted
2/06/2015
Date registered
4/06/2015
Date last updated
28/07/2020

Titles & IDs
Public title
A Safety and Efficacy Study of Abicipar Pegol in Participants With Neovascular Age-related Macular Degeneration
Scientific title
Safety and Efficacy of Abicipar Pegol (AGN-150998) in Patients With Neovascular Age-related Macular Degeneration (CEDAR Study)
Secondary ID [1] 0 0
2014-004579-22
Secondary ID [2] 0 0
150998-005
Universal Trial Number (UTN)
Trial acronym
CEDAR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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 - Abicipar Pegol
Treatment: Drugs - Ranibizumab
Other interventions - Sham Procedure

Experimental: Abicipar Pegol 2 mg (2Q8) - Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 8 and every 8 weeks (2Q8) thereafter through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.

Experimental: Abicipar Pegol 2 mg (2Q12) - Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 12, and every 12 weeks (2Q12) thereafter through week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.

Active comparator: Ranibizumab 0.5 mg (rQ4) - Ranibizumab (Lucentis®) 0.5 mg was administered to the study eye by intravitreal injection every 4 weeks (rQ4) from Day 1 through Week 96.


Treatment: Drugs: Abicipar Pegol
Abicipar pegol intravitreal injection.

Treatment: Drugs: Ranibizumab
Ranibizumab intravitreal injection.

Other interventions: Sham Procedure
Sham injection.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Stable Vision at Week 52
Timepoint [1] 0 0
Baseline to Week 52
Secondary outcome [1] 0 0
Mean Change From Baseline in BCVA in the Study Eye at Week 52
Timepoint [1] 0 0
Baseline to Week 52
Secondary outcome [2] 0 0
Mean Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye at Week 52
Timepoint [2] 0 0
Baseline to Week 52
Secondary outcome [3] 0 0
Percentage of Participants With a Gain of 15 or More ETDRS Letters in BCVA From Baseline in Study Eye at Week 52
Timepoint [3] 0 0
Baseline to Week 52
Secondary outcome [4] 0 0
Mean Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) Composite Score in Study Eye at Week 52
Timepoint [4] 0 0
Baseline to Week 52

Eligibility
Key inclusion criteria
* Diagnosis of age-related macular degeneration in at least 1 eye
* Best corrected visual acuity of 20/40 to 20/320 in the study eye
* Best corrected visual acuity of 20/200 or better in the non-study eye
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* History of vitrectomy, macular surgery, or glaucoma surgery in the study eye
* Cataract or refractive surgery in the study eye within the last 3 months

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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/06/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/06/2019
Sample size
Target
Accrual to date
Final
939
Recruitment in Australia
Recruitment state(s)
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
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Hawaii
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
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Louisiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Massachusetts
Country [12] 0 0
United States of America
State/province [12] 0 0
Michigan
Country [13] 0 0
United States of America
State/province [13] 0 0
Minnesota
Country [14] 0 0
United States of America
State/province [14] 0 0
Nevada
Country [15] 0 0
United States of America
State/province [15] 0 0
New Jersey
Country [16] 0 0
United States of America
State/province [16] 0 0
New York
Country [17] 0 0
United States of America
State/province [17] 0 0
North Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Ohio
Country [19] 0 0
United States of America
State/province [19] 0 0
Pennsylvania
Country [20] 0 0
United States of America
State/province [20] 0 0
South Carolina
Country [21] 0 0
United States of America
State/province [21] 0 0
Texas
Country [22] 0 0
United States of America
State/province [22] 0 0
Utah
Country [23] 0 0
United States of America
State/province [23] 0 0
Virginia
Country [24] 0 0
Argentina
State/province [24] 0 0
Buenos Aires
Country [25] 0 0
Argentina
State/province [25] 0 0
Santa Fe
Country [26] 0 0
Argentina
State/province [26] 0 0
Cordoba
Country [27] 0 0
Argentina
State/province [27] 0 0
Mendoza
Country [28] 0 0
Austria
State/province [28] 0 0
Graz
Country [29] 0 0
Austria
State/province [29] 0 0
Innsbruck
Country [30] 0 0
Austria
State/province [30] 0 0
Linz
Country [31] 0 0
Chile
State/province [31] 0 0
Las Condes
Country [32] 0 0
Chile
State/province [32] 0 0
Región Metropolitana
Country [33] 0 0
Colombia
State/province [33] 0 0
Valle Del Cauca
Country [34] 0 0
Colombia
State/province [34] 0 0
Bogota
Country [35] 0 0
Czechia
State/province [35] 0 0
Brno
Country [36] 0 0
Czechia
State/province [36] 0 0
Olomouc
Country [37] 0 0
Czechia
State/province [37] 0 0
Praha
Country [38] 0 0
France
State/province [38] 0 0
Bordeaux
Country [39] 0 0
France
State/province [39] 0 0
Creteil
Country [40] 0 0
France
State/province [40] 0 0
Lyon cedex 04
Country [41] 0 0
France
State/province [41] 0 0
Nantes Cedex 1
Country [42] 0 0
France
State/province [42] 0 0
Paris
Country [43] 0 0
France
State/province [43] 0 0
Saint Cyr sur Loire
Country [44] 0 0
Germany
State/province [44] 0 0
Bad Godesberg
Country [45] 0 0
Germany
State/province [45] 0 0
Dresden
Country [46] 0 0
Germany
State/province [46] 0 0
Dusseldorf
Country [47] 0 0
Germany
State/province [47] 0 0
Freiburg
Country [48] 0 0
Germany
State/province [48] 0 0
Gottingen
Country [49] 0 0
Germany
State/province [49] 0 0
Karlsruhe
Country [50] 0 0
Germany
State/province [50] 0 0
Leipzig
Country [51] 0 0
Germany
State/province [51] 0 0
Marburg
Country [52] 0 0
Germany
State/province [52] 0 0
Neubrandenburg
Country [53] 0 0
Germany
State/province [53] 0 0
Regensburg
Country [54] 0 0
Hong Kong
State/province [54] 0 0
Aberdeen
Country [55] 0 0
Hong Kong
State/province [55] 0 0
Kowloon
Country [56] 0 0
Israel
State/province [56] 0 0
Haifa
Country [57] 0 0
Israel
State/province [57] 0 0
Holon
Country [58] 0 0
Israel
State/province [58] 0 0
Kfar-Saba
Country [59] 0 0
Israel
State/province [59] 0 0
Petach Tikva
Country [60] 0 0
Israel
State/province [60] 0 0
Rehovot
Country [61] 0 0
Israel
State/province [61] 0 0
Tel Aviv
Country [62] 0 0
Israel
State/province [62] 0 0
Tel Hashomer
Country [63] 0 0
Israel
State/province [63] 0 0
Zerifin
Country [64] 0 0
Korea, Republic of
State/province [64] 0 0
Gyeonggi-do
Country [65] 0 0
Korea, Republic of
State/province [65] 0 0
Seoul
Country [66] 0 0
Latvia
State/province [66] 0 0
LV
Country [67] 0 0
New Zealand
State/province [67] 0 0
Auckland
Country [68] 0 0
Philippines
State/province [68] 0 0
Metro Manila
Country [69] 0 0
Singapore
State/province [69] 0 0
Singapore
Country [70] 0 0
Spain
State/province [70] 0 0
Barcelona
Country [71] 0 0
Spain
State/province [71] 0 0
Bilbao
Country [72] 0 0
Spain
State/province [72] 0 0
Madrid
Country [73] 0 0
Spain
State/province [73] 0 0
Pamplona
Country [74] 0 0
Spain
State/province [74] 0 0
Valencia
Country [75] 0 0
Spain
State/province [75] 0 0
Valladolid
Country [76] 0 0
Spain
State/province [76] 0 0
Zaragoza
Country [77] 0 0
Switzerland
State/province [77] 0 0
Bern
Country [78] 0 0
Switzerland
State/province [78] 0 0
Binningen
Country [79] 0 0
Switzerland
State/province [79] 0 0
Zurich

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

Ethics approval
Ethics application status

Summary
Brief summary
This is a safety and efficacy study of abicipar pegol in participants with neovascular age-related macular degeneration.
Trial website
https://clinicaltrials.gov/study/NCT02462928
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Joanne Li
Address 0 0
Allergan
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/study/NCT02462928