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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02581891




Registration number
NCT02581891
Ethics application status
Date submitted
20/10/2015
Date registered
21/10/2015
Date last updated
1/05/2019

Titles & IDs
Public title
Managing Neovascular (Known as "Wet") Age-related Macular Degeneration Over 2 Years Using Different Treatment Schedules of 2 mg Intravitreal Aflibercept Injected in the Eye
Scientific title
Managing Neovascular Age-related Macular Degeneration (nAMD) Over 2 Years With a Treat and Extend (T&E) Regimen of 2 mg Intravitreal Aflibercept - a Randomized, Open-label, Active-controlled, Parallel-group Phase IV/IIIb Study (ARIES)
Secondary ID [1] 0 0
2014-003132-39
Secondary ID [2] 0 0
17508
Universal Trial Number (UTN)
Trial acronym
ARIES
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 - Eylea (Intravitreal Aflibercept, VEGF Trap-Eye, BAY86-5321)
Treatment: Drugs - Eylea (Intravitreal Aflibercept, VEGF Trap-Eye, BAY86-5321)

Experimental: Early-start T&E / Arm 1 - Early-start T&E arm: test group, early treatment individualization

Active Comparator: Late-start T&E / Arm 2 - Late-start T&E arm; per label, control group, treatment individualization after Year 1


Treatment: Drugs: Eylea (Intravitreal Aflibercept, VEGF Trap-Eye, BAY86-5321)
3 monthly doses followed by individualized treatment intervals of between 8 to16 weeks based on protocol-defined anatomical criteria

Treatment: Drugs: Eylea (Intravitreal Aflibercept, VEGF Trap-Eye, BAY86-5321)
3 monthly doses followed by five 8-weekly doses (5 x 2Q8), then by individualized treatment intervals of between 8 to 16 weeks based on protocol-defined anatomical criteria

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in best corrected visual acuity (BCVA) as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score
Timepoint [1] 0 0
Week 104
Secondary outcome [1] 0 0
Proportion of subjects maintaining vision (<3 lines loss)
Timepoint [1] 0 0
Weeks 52 and 104
Secondary outcome [2] 0 0
Change in BCVA as measured by the ETDRS letter score
Timepoint [2] 0 0
Weeks 52 and 104
Secondary outcome [3] 0 0
Change in central retinal thickness (CRT)
Timepoint [3] 0 0
Weeks 52 and 104
Secondary outcome [4] 0 0
Number of study drug injections
Timepoint [4] 0 0
Weeks 52 and 104
Secondary outcome [5] 0 0
Duration of last re-treatment interval
Timepoint [5] 0 0
Week 104
Secondary outcome [6] 0 0
Proportion of subjects requiring retreatment at 8, 10, 12, 14, and 16 weeks as the last treatment interval
Timepoint [6] 0 0
Week 104
Secondary outcome [7] 0 0
Proportion of 3-line vision gainers
Timepoint [7] 0 0
Weeks 52 and 104

Eligibility
Key inclusion criteria
- Men and women = 50 years of age.

- Active primary subfoveal CNV lesions secondary to nAMD, including juxtafoveal lesions
that affect the fovea as evidenced by FA in the study eye. Patients with polypoidal
choroidal vasculopathy or retinal angiomatous proliferation are eligible to
participate in the study, and their condition should be captured in the eCRF.

- ETDRS BCVA of 73 to 25 letters (20/40 to 20/320 Snellen equivalent) in the study eye.

- The area of CNV must occupy at least 50% of the total lesion.
Minimum age
50 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Any prior ocular (in the study eye) or systemic treatment or surgery for nAMD, except
dietary supplements or vitamins.

- Any prior or concomitant therapy with another investigational agent to treat nAMD in
the study eye.

- Prior treatment with anti-VEGF agents as follows:

- Prior treatment with anti-VEGF therapy in the study eye is not allowed

- Prior treatment with anti-VEGF therapy in the fellow eye with an investigational agent
(not approved, e.g. bevacizumab) within the last 3 months before the first dose in the
study. Such treatment will also not be allowed during the study. Prior treatment with
an approved anti-VEGF therapy in the fellow eye is allowed.

- Prior systemic anti-VEGF therapy, investigational or approved, within the last 3
months before the first dose in the study, and such treatment will not be allowed
during the study.

- Total lesion size >12 disc areas (30.5 mm2, including blood, scars and
neovascularization) as assessed by FA in the study eye.

- Subretinal hemorrhages that are either 50% or more of the total lesion area, or if the
blood is under the fovea and is 1 or more disc areas in size in the study eye. (If the
blood is under the fovea, then the fovea must be surrounded by 270 degrees by visible
CNV).

- Scar or fibrosis making up >50% of the total lesion in the study eye.

- Scar, fibrosis, or atrophy involving the center of the fovea in the study eye.

- Presence of retinal pigment epithelial tears or rips involving the macula 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
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
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
Recruitment hospital [2] 0 0
- Sydney
Recruitment hospital [3] 0 0
- Westmead
Recruitment hospital [4] 0 0
- East Melbourne
Recruitment hospital [5] 0 0
- Launceston
Recruitment postcode(s) [1] 0 0
2135 - Strathfield
Recruitment postcode(s) [2] 0 0
2000 - Sydney
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
3002 - East Melbourne
Recruitment postcode(s) [5] 0 0
7249 - Launceston
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Ontario
Country [2] 0 0
Canada
State/province [2] 0 0
Quebec
Country [3] 0 0
France
State/province [3] 0 0
Creteil Cedex
Country [4] 0 0
France
State/province [4] 0 0
Nice cedex 1
Country [5] 0 0
Germany
State/province [5] 0 0
Baden-Württemberg
Country [6] 0 0
Germany
State/province [6] 0 0
Niedersachsen
Country [7] 0 0
Germany
State/province [7] 0 0
Nordrhein-Westfalen
Country [8] 0 0
Germany
State/province [8] 0 0
Saarland
Country [9] 0 0
Germany
State/province [9] 0 0
Sachsen
Country [10] 0 0
Germany
State/province [10] 0 0
Berlin
Country [11] 0 0
Hungary
State/province [11] 0 0
Budapest
Country [12] 0 0
Hungary
State/province [12] 0 0
Debrecen
Country [13] 0 0
Hungary
State/province [13] 0 0
Pecs
Country [14] 0 0
Hungary
State/province [14] 0 0
Szombathely
Country [15] 0 0
Italy
State/province [15] 0 0
Lazio
Country [16] 0 0
Italy
State/province [16] 0 0
Lombardia
Country [17] 0 0
Italy
State/province [17] 0 0
Veneto
Country [18] 0 0
Spain
State/province [18] 0 0
Asturias
Country [19] 0 0
Spain
State/province [19] 0 0
Madrid
Country [20] 0 0
Spain
State/province [20] 0 0
Zaragoza
Country [21] 0 0
United Kingdom
State/province [21] 0 0
Kent
Country [22] 0 0
United Kingdom
State/province [22] 0 0
Bristol
Country [23] 0 0
United Kingdom
State/province [23] 0 0
Liverpool
Country [24] 0 0
United Kingdom
State/province [24] 0 0
London
Country [25] 0 0
United Kingdom
State/province [25] 0 0
Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bayer
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Regeneron Pharmaceuticals
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This study aims to evaluate the optimal use, efficacy, and safety of a Treat-and-Extend
regimen with aflibercept in subjects with nAMD.
Trial website
https://clinicaltrials.gov/show/NCT02581891
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bayer Study Director
Address 0 0
Bayer
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
Other publications