Central Retinal Vein OcclusionPhase 4CENTERANCT02800642
Evaluation of a Treat and Extend Regimen of Intravitreal Aflibercept for Macular Edema Secondary to CRVO
A Phase 4 study testing Aflibercept (Eylea, BAY86-5321) in people with Central Retinal Vein Occlusion, run by Bayer at 42 sites in 8 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Retinal Vein Occlusion
- What is being tested?
- Aflibercept (Eylea, BAY86-5321)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 42 sitesin 8 countries
- Study dates
- 10 Jun 2016to 31 Jul 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
42 sites in 8 countries.
42 sites in 8 countries
Germany10 sites
Study site
Augsburg, Bavaria, 86156
Study site
Cologne, North Rhine-Westphalia, 50935
Study site
Düsseldorf, North Rhine-Westphalia, 40225
Study site
Freiburg im Breisgau, Baden-Wurttemberg, 79106
Study site
Göttingen, Lower Saxony, 37075
Study site
Hannover, North Rhine-Westphalia, 30625
Study site
Heidelberg, Baden-Wurttemberg, 69120
Study site
Karlsruhe, Baden-Wurttemberg, 76133
Study site
Leipzig, Saxony, 04103
Study site
Münster, North Rhine-Westphalia, 48149
Italy7 sites
Study site
Ancona, The Marches, 60126
Study site
Milan, Lombardy, 20132
Study site
Milan, Lombardy, 20157
Study site
Padova, Veneto, 35128
Study site
Pisa, Tuscany, 56124
Study site
Rome, Lazio, 00133
Study site
Rome, Lazio, 00198
Canada6 sites
Study site
Boisbriand, Quebec, J7H 1S6
Study site
Calgary, Alberta, T2H 0C8
Study site
Hamilton, Ontario, L8G 5E4
Study site
London, Ontario, N6A 4V2
Study site
Québec, G1V 1T6
Study site
Sherbrooke, Quebec, J1G 2V4
United Kingdom6 sites
Study site
Bradford, West Yorkshire, BD9 6RJ
Study site
Bristol, BS1 2LX
Study site
Colchester, CO3 3NB
Study site
Liverpool, L9 7AL
Study site
Oxford, OX3 9DU
Study site
Sunderland, Tyne and Wear, SR2 9HP
Spain5 sites
Study site
Barcelona, 08024
Study site
Barcelona, 08025
Study site
Oviedo, Principality of Asturias, 33012
Study site
Sant Cugat Del Vallés, Barcelona, 08195
Study site
Viladecans, Barcelona, 08840
Australia3 sites
Study site
Albury, New South Wales, 2640
Study site
Parramatta, 2150
Study site
Sydney, New South Wales, 2000
France3 sites
Study site
Bordeaux, 33076
Study site
Dijon, BP 1542-21
Study site
Lyon, 69004
About this study
Official 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
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.
- Conditions
- Central Retinal Vein Occlusion
- Being tested
- Aflibercept (Eylea, BAY86-5321)
- Keywords
- Bayer, Aflibercept, Eylea, Intravitreal
- Medical subject headings
- Retinal Vein Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aflibercept (Eylea, BAY86-5321)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Intravitreal (IVT) aflibercept | Experimental | Participants with macular edema secondary to CRVO were treated with the study drug intravitreal aflibercept Receives: Drug: Aflibercept (Eylea, BAY86-5321) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 24 and Week 76
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
Measured: From the last actual visit of the initiation phase to Week 76
Secondary outcomes (8)
The Mean Treatment Interval Between Injections
Measured: From baseline to Week 76
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
Measured: Baseline and Week 24, 52, and 76
The Change in Central Retinal Thickness (CRT) From Baseline
CRT was measured in the study eye by spectral domain optical coherence tomography (SD-OCT).
Measured: Baseline and Week 24, 52 and 76
The Number of Injections Per Participant
Measured: From baseline to Week 76
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
Measured: Baseline and Week 24, Week 52
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
Measured: Baseline and Week 24, 52 and 76
The Proportion of Participants With Absence of Subretinal Fluid
Measured: Baseline, week 24, week 52 and week 76
Incidence and Severity of Ocular Treatment-emergent Adverse Events
Measured: Up to 30 days after week 76
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study start10 Jun 2016
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Central Retinal Vein OcclusionStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02800642
- Sponsor's protocol ID
- 17514
- Other IDs
- 2014-003193-17, 2014
- Acronym
- CENTERA
- Status last verified
- Jun 2020
- First submitted
- 10 Jun 2016
- Last updated
- 8 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Korobelnik JF, Larsen M, Eter N, Bailey C, Wolf S, Schmelter T, Allmeier H, Chaudhary V. Efficacy and Safety of Intravitreal Aflibercept Treat-and-Extend for Macular Edema in Central Retinal Vein Occlusion: the CENTERA Study. Am J Ophthalmol. 2021 Jul;227:106-115. doi: 10.1016/j.ajo.2021.01.027. Epub 2021 Feb 6.
PubMed 33556381
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02800642
- Acronym / sponsor ID
- CENTERA / 17514
- Conditions
- Central Retinal Vein Occlusion
- Keywords
- Bayer, Aflibercept, Eylea, Intravitreal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 10 Jun 2016 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 15 Jun 2016 (estimated)
- Results
- Posted 8 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intravitreal (IVT) aflibercept | Experimental | Drug: Aflibercept (Eylea, BAY86-5321)Participants with macular edema secondary to CRVO were treated with the study drug intravitreal aflibercept |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Intravitreal (IVT) aflibercept |
Primary outcome
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
Time frame: Baseline, Week 24 and Week 76
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.
The Proportion of Participants With a Mean Treatment Interval Between Injections of ≥ 8 Weeks
Time frame: From the last actual visit of the initiation phase to Week 76
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
8 secondary outcomes
The Mean Treatment Interval Between Injections
Time frame: From baseline to Week 76
The Change in Best Corrected Visual Acuity (BCVA) as Measured by the Early Treatment Diabetic Retinopathy Letter Score (ETDRS) From Baseline
Time frame: Baseline and Week 24, 52, and 76
The Change in Central Retinal Thickness (CRT) From Baseline
Time frame: Baseline and Week 24, 52 and 76
The Number of Injections Per Participant
Time frame: From baseline to Week 76
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
Time frame: Baseline and Week 24, Week 52
The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline
Time frame: Baseline and Week 24, 52 and 76
The Proportion of Participants With Absence of Subretinal Fluid
Time frame: Baseline, week 24, week 52 and week 76
Incidence and Severity of Ocular Treatment-emergent Adverse Events
Time frame: Up to 30 days after week 76
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33556381Korobelnik JF, Larsen M, Eter N, Bailey C, Wolf S, Schmelter T, Allmeier H, Chaudhary V. Efficacy and Safety of Intravitreal Aflibercept Treat-and-Extend for Macular Edema in Central Retinal Vein Occlusion: the CENTERA Study. Am J Ophthalmol. 2021 Jul;227:106-115. doi: 10.1016/j.ajo.2021.01.027. Epub 2021 Feb 6.
- Click here to find information about studies related to Bayer Healthcare products conducted in EuropeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
42 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aflibercept (Eylea, BAY86-5321) in people with Central Retinal Vein Occlusion, run by Bayer at 42 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in Germany, Italy, Canada, United Kingdom, Spain and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Baseline, Week 24 and Week 76). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02800642, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2020.