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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02800642




Registration number
NCT02800642
Ethics application status
Date submitted
10/06/2016
Date registered
15/06/2016
Date last updated
8/07/2020

Titles & IDs
Public title
Evaluation of a Treat and Extend Regimen of Intravitreal Aflibercept for Macular Edema Secondary to CRVO
Scientific title
A Multi-center, Single-arm, Interventional Phase 4 Study to Evaluate a Treat and Extend Regimen of Intravitreal Aflibercept for Treatment of Macular Edema Secondary to Central Retinal Vein Occlusion
Secondary ID [1] 0 0
2014-003193-17
Secondary ID [2] 0 0
17514
Universal Trial Number (UTN)
Trial acronym
CENTERA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Central 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 - Aflibercept (Eylea, BAY86-5321)

Experimental: Intravitreal (IVT) aflibercept - Participants with macular edema secondary to CRVO were treated with the study drug intravitreal aflibercept


Treatment: Drugs: Aflibercept (Eylea, BAY86-5321)
The recommended dose for intravitreal aflibercept was 2 mg equivalent to 50 µL. Study treatment was administered at baseline and at monthly intervals until stabilization of disease. When stability was achieved, the treatment interval could be extended based on visual and anatomic outcomes as judged by the treating investigator.

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

Outcomes
Primary outcome [1] 0 0
The Proportion of Participants Who Gained = 15 Letters in Best Corrected Visual Acuity (BCVA) on the Early Treatment Diabetic Retinopathy Score (ETDRS) Chart Compared to Baseline - Participants who completed the study with a gain of = 15 letters or dropped the study after Week 24 and having a permanent resolution of macular edema and a gain of = 15 letters from baseline with regard to the latest BCVA assessment. The ETDRS chart includes 70 letters in total, more letters read correctly represents a better visual acuity.
Timepoint [1] 0 0
Baseline, Week 24 and Week 76
Primary outcome [2] 0 0
The Proportion of Participants With a Mean Treatment Interval Between Injections of = 8 Weeks - Participants who completed the study with a mean treatment interval between injections of = 8 weeks or dropped out of the study after Week 24 and having a permanent resolution of macular edema
Timepoint [2] 0 0
From the last actual visit of the initiation phase to Week 76
Secondary outcome [1] 0 0
The Mean Treatment Interval Between Injections
Timepoint [1] 0 0
From baseline to Week 76
Secondary outcome [2] 0 0
The Change in Best Corrected Visual Acuity (BCVA) as Measured by the Early Treatment Diabetic Retinopathy Letter Score (ETDRS) From Baseline - The ETDRS chart includes 70 letters in total and the letter score ranges from 0 to 100. More letters read correctly results in a higher letter score, which represents better visual acuity
Timepoint [2] 0 0
Baseline and Week 24, 52, and 76
Secondary outcome [3] 0 0
The Change in Central Retinal Thickness (CRT) From Baseline - CRT was measured in the study eye by spectral domain optical coherence tomography (SD-OCT).
Timepoint [3] 0 0
Baseline and Week 24, 52 and 76
Secondary outcome [4] 0 0
The Number of Injections Per Participant
Timepoint [4] 0 0
From baseline to Week 76
Secondary outcome [5] 0 0
The Proportion of Participants Who Gain = 15 Letters in Best Corrected Visual Acuity (BCVA) on the Early Treatment Diabetic Retinopathy Score (ETDRS) Chart Compared to Baseline - The ETDRS chart includes 70 letters in total. More letters read correctly represents a better visual acuity
Timepoint [5] 0 0
Baseline and Week 24, Week 52
Secondary outcome [6] 0 0
The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline - The change in retinal non-perfusion status by fundus angiography (FA)/fundus photography (FP)-confirmed ischemic disc area. The status was categorized into: no non-perfusion, <10 ischemic disc area, >=10 ischemic disc area and missing status
Timepoint [6] 0 0
Baseline and Week 24, 52 and 76
Secondary outcome [7] 0 0
The Proportion of Participants With Absence of Subretinal Fluid
Timepoint [7] 0 0
Baseline, week 24, week 52 and week 76
Secondary outcome [8] 0 0
Incidence and Severity of Ocular Treatment-emergent Adverse Events
Timepoint [8] 0 0
Up to 30 days after week 76

Eligibility
Key inclusion criteria
- Center-involved macular edema secondary to CRVO for no longer than 3 months (at the
screening visit it should be ensured that the subjects will comply with the criterion
of = 3 months since onset of macular edema at their scheduled baseline visit).

- Adult subjects diagnosed with macular edema secondary to CRVO who are scheduled to be
treated with IVT aflibercept as per investigator's routine treatment practice with the
intent to use a T&E regimen after initial dosing.

- Treatment-naïve subjects for macular edema secondary to CRVO.

- Men and women = 18 years of age.

- Documented BCVA of ETDRS letter score of 73 to 24 letters (Snellen equivalent of 20/40
to 20/320) 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
- Previous PRP or macular laser photocoagulation in the study eye.

- Any prior or concomitant ocular treatment (e.g. anti-VEGF therapy, corticosteroids) in
the study eye for macular edema secondary to RVO, except dietary supplements or
vitamins prior to inclusion in the study. Intraocular anti-VEGF treatment is permitted
for the treatment of diseases of fellow eye except for those that are specifically
excluded.

- Prior systemic anti-VEGF or corticosteroid therapy, investigational or approved,
within the last 3 months before the first dose in the study.

- Previous use of intraocular corticosteroids in the study eye at any time or use of
periocular corticosteroids in the study eye within 12 months prior to Day 1.

- Any active intraocular, extraocular, and periocular inflammation or infection in
either eye within 4 weeks of screening.

- Any history of allergy to povidone iodine.

- Known serious allergy to the fluorescein sodium for injection in angiography.

- Presence of any contraindications indicated in the EU commission/locally approved
label for IVT aflibercept: hypersensitivity to the active substance IVT aflibercept or
to any of the excipients; active or suspected ocular or periocular infection; active
severe intraocular inflammation.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Single group
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
Recruitment hospital [1] 0 0
- Albury
Recruitment hospital [2] 0 0
- Sydney
Recruitment hospital [3] 0 0
- Parramatta
Recruitment postcode(s) [1] 0 0
2640 - Albury
Recruitment postcode(s) [2] 0 0
2000 - Sydney
Recruitment postcode(s) [3] 0 0
2150 - Parramatta
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Alberta
Country [2] 0 0
Canada
State/province [2] 0 0
Ontario
Country [3] 0 0
Canada
State/province [3] 0 0
Quebec
Country [4] 0 0
Denmark
State/province [4] 0 0
Aalborg
Country [5] 0 0
Denmark
State/province [5] 0 0
Glostrup
Country [6] 0 0
France
State/province [6] 0 0
Bordeaux
Country [7] 0 0
France
State/province [7] 0 0
Dijon Cedex
Country [8] 0 0
France
State/province [8] 0 0
Lyon
Country [9] 0 0
Germany
State/province [9] 0 0
Baden-Württemberg
Country [10] 0 0
Germany
State/province [10] 0 0
Bayern
Country [11] 0 0
Germany
State/province [11] 0 0
Niedersachsen
Country [12] 0 0
Germany
State/province [12] 0 0
Nordrhein-Westfalen
Country [13] 0 0
Germany
State/province [13] 0 0
Sachsen
Country [14] 0 0
Italy
State/province [14] 0 0
Lazio
Country [15] 0 0
Italy
State/province [15] 0 0
Lombardia
Country [16] 0 0
Italy
State/province [16] 0 0
Marche
Country [17] 0 0
Italy
State/province [17] 0 0
Toscana
Country [18] 0 0
Italy
State/province [18] 0 0
Veneto
Country [19] 0 0
Spain
State/province [19] 0 0
Asturias
Country [20] 0 0
Spain
State/province [20] 0 0
Barcelona
Country [21] 0 0
United Kingdom
State/province [21] 0 0
Tyne And Wear
Country [22] 0 0
United Kingdom
State/province [22] 0 0
West Yorkshire
Country [23] 0 0
United Kingdom
State/province [23] 0 0
Bristol
Country [24] 0 0
United Kingdom
State/province [24] 0 0
Colchester
Country [25] 0 0
United Kingdom
State/province [25] 0 0
Liverpool
Country [26] 0 0
United Kingdom
State/province [26] 0 0
Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bayer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Central retinal vein occlusion (CRVO) occurs when the main blood vessel that transports blood
away from the retina (the very back portion of the eye) becomes blocked, causing the leakage
of fluid into the retina and thereby causing a swelling of the macula (the portion of the
retina responsible for fine vision). This swelling is called macular edema. When the macula
swells with fluid, central vision becomes blurry. The study drug aflibercept has been shown
to reduce the amount of fluid and blood leaked into the retina. It can help to stabilize, and
in many cases, improve the vision loss related to CRVO. Aflibercept has been approved for the
treatment of macular edema secondary to CRVO in the United States (US), European Union (EU),
Japan, and other countries.

The study was considered research because, although the study drug was already on the market
for macular edema secondary to CRVO, there were no studies available that addressed the
questions of what were useful intervals for treating and assessing patients, how did they
differ among patients, and how were criteria applied for retreatment. The purpose of this
study was to evaluate the effectiveness, treatment interval, and safety of the treatment
regimen (pattern for administering treatment) in subjects with macular edema secondary to
CRVO. In addition, this study explored new imaging methods for assessing the affected eye.
Trial website
https://clinicaltrials.gov/show/NCT02800642
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