Visual ImpairmentPhase 3COMRADE-CNCT01396083

Efficacy and Safety of Ranibizumab Intravitreal Injections Versus Dexamethasone Intravitreal Implant in Patients With Central Retinal Vein Occlusion (CRVO)

A Phase 3 study testing Ranibizumab in people with Visual Impairment and Macular Edema, run by Novartis Pharmaceuticals at 64 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This clinical trial is designed to compare ranibizumab in comparison with Dexamethasone implant® after 6 months of treatment. In the study arm Lucentis will be given monthly in a pro re nata scheme whereas the comparator Dexamethasone implant is given once at Month 0 with sham injections PRN afterwards. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Visual Impairment, Macular Edema, Central Retinal Vein Occlusion
What is being tested?: Ranibizumab
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 243 participants
Where: 64 sitesin 4 countries
Study dates: Aug 2011to Jan 2014
Phase: Phase 3
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

Patients diagnosed with visual impairment due to macular edema following CRVO
Diagnosis of CRVO at maximum 6 months prior to Screening
BCVA using ETDRS charts of 20/40 to 20/400 in the study eye

Who cannot join

Media clarity, pupillary dilation and patient cooperation not sufficient for adequate fundus photographs
Central retinal thickness (CRT) < 250 µm in the study eye
Prior episode of RVO in the study eye
Active formation of new vessels in the study eye
Anti-VEGF-treatment in the study or the fellow eye 3 months prior to Baseline
IOP ≥ 30mmHg or uncontrolled glaucoma; patients may be re-screened after 1 month if they have undergone glaucoma treatment
Improvement of > 10 letters on BCVA between Screening and Baseline
Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

64 sites in 4 countries.

Country

City, postcode or hospital

64 sites in 4 countries

Germany41 sites

Novartis Investigative Site
Augsburg, 85155
Novartis Investigative Site
Bad Rothenfelde, 49215
Novartis Investigative Site
Berlin, 10713
Novartis Investigative Site
Berlin, 13353
Novartis Investigative Site
Bonn, 53127
Novartis Investigative Site
Bremen, 28209
Novartis Investigative Site
Chemnitz, 09116
Novartis Investigative Site
Cologne, 50935
Novartis Investigative Site
Darmstadt, 64298
Novartis Investigative Site
Dortmund, 44137
Novartis Investigative Site
Dresden, 01307
Novartis Investigative Site
Düsseldorf, 40225
Novartis Investigative Site
Frankfurt, 60318
Novartis Investigative Site
Freiburg I. Br, 79106
Novartis Investigative Site
Glauchau, 08371
Novartis Investigative Site
Göttingen, 37075
Novartis Investigative Site
Hagen, 58097
Novartis Investigative Site
Hamburg, 20246
Novartis Investigative Site
Hamburg, 22417
Novartis Investigative Site
Homburg, 66421
Novartis Investigative Site
Ingolstadt, 85049
Novartis Investigative Site
Karlsruhe, 76133
Novartis Investigative Site
Karlsruhe, 76199
Novartis Investigative Site
Kiel, 24105
Novartis Investigative Site
Lauterbach, 36341
Novartis Investigative Site
Leipzig, Germany, 04103
Novartis Investigative Site
Ludwigshafen, 67063
Novartis Investigative Site
Minden, 32427
Novartis Investigative Site
Mülheim, 45468
Novartis Investigative Site
München, 80336
Novartis Investigative Site
München, 81675
Novartis Investigative Site
Münster, 48145
Novartis Investigative Site
Münster, 48149
Novartis Investigative Site
Nuremberg, 90491
Novartis Investigative Site
Recklinghausen, 45657
Novartis Investigative Site
Regensburg, Germany, 93042
Novartis Investigative Site
Sulzbach, 66280
Novartis Investigative Site
Tübingen, 72076
Novartis Investigative Site
Ulm, 89075
Novartis Investigative Site
Wolfsburg, 38442
Novartis Investigative Site
Würzburg, 97080

Other trials in Germany

United Kingdom18 sites

Novartis Investigative Site
Birmingham, B152WB
Novartis Investigative Site
Birmingham, B18 7QU
Novartis Investigative Site
Bradford, BD9 6RJ
Novartis Investigative Site
Cheshire, CW1 4QJ
Novartis Investigative Site
Colchester, CO3 3NB
Novartis Investigative Site
Derby, DE22 3NE
Novartis Investigative Site
Gloucester, GL1 3NN
Novartis Investigative Site
Guildford, Surrey, GU2 5XX
Novartis Investigative Site
Kent, CT1 3NG
Novartis Investigative Site
Leeds, LS9 7TF
Novartis Investigative Site
London, SE1 7EH
Novartis Investigative Site
Manchester, M13 9WH
Novartis Investigative Site
Middlesbrough, TS4 3BW
Novartis Investigative Site
Nottingham, NG7 2UH
Novartis Investigative Site
Portsmouth, PO6 3LY
Novartis Investigative Site
Rugby, CV22 5PX
Novartis Investigative Site
Westcliff-on-Sea, SS0 0RY
Novartis Investigative Site
York, YO31 8HE

Other trials in United Kingdom

Hungary3 sites

Novartis Investigative Site
Budapest, 1083
Novartis Investigative Site
Budapest, 1133
Novartis Investigative Site
Szeged, H-6720

Other trials in Hungary

Poland2 sites

Novartis Investigative Site
Bydgoszcz
Novartis Investigative Site
Bytom, 41-902

Other trials in Poland

About this study

Official title: A 6-month Multicenter, Randomized, Double-masked Phase IIIb-study Comparing the Efficacy and Safety of Ranibizumab Intravitreal Injections Versus Dexamethasone Intravitreal Implant in Patients With Visual Impairment Due to Macular Edema Following Central Retinal Vein Occlusion (CRVO)

Conditions: Visual Impairment, Macular Edema, Central Retinal Vein Occlusion
Being tested: Ranibizumab, Dexamethasone implant and sham injections
Keywords: Visual impairment, macular edema, Central retinal vein occlusion, Dexamethasone implant, Ranibizumab
Medical subject headings: Vision Disorders, Macular Edema, Retinal Vein Occlusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RanibizumabDrug
Dexamethasone implant and sham injectionsDrug

Study groups in NCT01396083
Study group	Role	What they receive
Ranibizumab	Experimental	Not described Receives: Drug: Ranibizumab
Standard of Care	Active comparator	Not described Receives: Drug: Dexamethasone implant and sham injections

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Average BCVA Change From Month 1 Through Month 6 to Baseline
the average of the changes in BCVA (letters) from baseline to any post-baseline visit, i.e. the mean of six differences to baseline for the six post-baseline visits at month 1 to 6. BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is pproximately 20/20. An increased score indicates improvement in acuity
Measured: Baseline, month 6

Secondary outcomes (9)

Mean BCVA Change at Month 6
The analysis was performed by an analysis of covariance (ANCOVA) model with average change in BCVA (letters) from Visit 1 through Visit 6 as dependent variable, and with the factors center, treatment and covariate baseline BCVA as predictors
Measured: Baseline, month 6
Number of Patients Gaining / Losing ≥ 15 / 10 / 5 Letters
BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the number of participants who gained 15, 10 or 5 more letters of visual acuity at month 6 as compared with baseline
Measured: Baseline, 6 month
Time to Achieve a Significant Improvement ≥ 15 Letters
The time was analyzed by the Kaplan-Maier-Method, adjusting the calculation for dropouts
Measured: Baseline, month 6
Change Over Time in BCVA
The analysis was performed by an analysis of covariance (ANCOVA) model with average change in BCVA (letters) from Visit 1 through Visit 6 as dependent variable, and with the factors center, treatment and covariate baseline BCVA as predictors
Measured: Baseline, month 6
Change Over Time of the Central Retinal Thickness (CRT)
Retinal thickness was measured using Optical Coherence Tomography (OCT). The images were reviewed by a central reading center to ensure a standardized evaluation
Measured: Baseline, month 6
Changes in the Quality of Life According to the National Eye Institute Visual Function Questionnaire (NEI-VFQ 25) Questionnaires
The VFQ-25 composite and subscale scores range from 0 to 100, a higher score indicating better functioning. The 12 subscales in the VFQ-25 are general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. The scores on the subscales were added together for a total score, which ranged from 0 to 100. A higher score indicated improvement in quality of life due to vision function
Measured: Baseline, month 6
Changes in the Quality of Life According to the Short Form (36) Health Survey (SF-36)Questionnaires
SF-36 summary measures are norm-based scores with mean = 50 and SD = 10. Higher scores indicate better health
Measured: Baseline, month 6
Changes in the Quality of Life According to Euro Quality of Life (EQ-5D) Questionnaires
The EQ-5D visual analog scale ranges from 0 to 100, 0 representing the worst and 100 the best imaginable health state.
Measured: Baseline, month 6
Increase Rate of the Internal Ocular Pressure (IOP ) : Patients With ≥10% Increase in IOP Compared to Baseline
The proportion of patients with ≥ 10% increase in Internal Ocular Pressure (IOP) compared to baseline at any post-baseline visit.
Measured: Baseline, month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2011Jan 2014

First posted18 Jul 2011 (estimated)
Study startAug 2011
Primary completionJan 2014
Study completionJan 2014

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.
Other trials for Visual ImpairmentStudies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 243 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01396083
Sponsor's protocol ID: CRFB002EDE18
Other IDs: 2011-001020-38
Acronym: COMRADE-C
Status last verified: Sep 2016
First submitted: 14 Jul 2011
Last updated: 27 Sep 2016
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 6-month Multicenter, Randomized, Double-masked Phase IIIb-study Comparing the Efficacy and Safety of Ranibizumab Intravitreal Injections Versus Dexamethasone Intravitreal Implant in Patients With Visual Impairment Due to Macular Edema Following Central Retinal Vein Occlusion (CRVO)
ClinicalTrials.gov ID: NCT01396083
Acronym / sponsor ID: COMRADE-C / CRFB002EDE18
Conditions: Visual Impairment, Macular Edema, Central Retinal Vein Occlusion
Keywords: Visual impairment, macular edema, Central retinal vein occlusion, Dexamethasone implant, Ranibizumab
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 243 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Aug 2011
Primary completion: Jan 2014 (actual)
Study completion: Jan 2014 (actual)
First posted: 18 Jul 2011 (estimated)
Results: Posted 18 Feb 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Ranibizumab	Experimental	Drug: Ranibizumab
Standard of Care	Active comparator	Drug: Dexamethasone implant and sham injections

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patients diagnosed with visual impairment due to macular edema following CRVO
Diagnosis of CRVO at maximum 6 months prior to Screening
BCVA using ETDRS charts of 20/40 to 20/400 in the study eye

Key exclusion criteria (8 listed)

Media clarity, pupillary dilation and patient cooperation not sufficient for adequate fundus photographs
Central retinal thickness (CRT) < 250 µm in the study eye
Prior episode of RVO in the study eye
Active formation of new vessels in the study eye
Anti-VEGF-treatment in the study or the fellow eye 3 months prior to Baseline

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
Ranibizumab	Drug	Ranibizumab
Dexamethasone implant and sham injections	Drug	Standard of Care

Primary outcome

Mean Average BCVA Change From Month 1 Through Month 6 to Baseline
Time frame: Baseline, month 6
the average of the changes in BCVA (letters) from baseline to any post-baseline visit, i.e. the mean of six differences to baseline for the six post-baseline visits at month 1 to 6. BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is pproximately 20/20. An increased score indicates improvement in acuity

9 secondary outcomes

Mean BCVA Change at Month 6
Time frame: Baseline, month 6
Number of Patients Gaining / Losing ≥ 15 / 10 / 5 Letters
Time frame: Baseline, 6 month
Time to Achieve a Significant Improvement ≥ 15 Letters
Time frame: Baseline, month 6
Change Over Time in BCVA
Time frame: Baseline, month 6
Change Over Time of the Central Retinal Thickness (CRT)
Time frame: Baseline, month 6
Changes in the Quality of Life According to the National Eye Institute Visual Function Questionnaire (NEI-VFQ 25) Questionnaires
Time frame: Baseline, month 6
Changes in the Quality of Life According to the Short Form (36) Health Survey (SF-36)Questionnaires
Time frame: Baseline, month 6
Changes in the Quality of Life According to Euro Quality of Life (EQ-5D) Questionnaires
Time frame: Baseline, month 6
Increase Rate of the Internal Ocular Pressure (IOP ) : Patients With ≥10% Increase in IOP Compared to Baseline
Time frame: Baseline, month 6

Results and safety

Results posted to the registry on 18 Feb 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ranibizumab	124	113
Dexamethasone	119	72

Primary outcome: Mean Average BCVA Change From Month 1 Through Month 6 to Baseline

Time frame: Baseline, month 6. Mean (Standard Deviation). Unit: Letters

Measure	Ranibizumab n = 124	Dexamethasone n = 119
Value	14.6 (11.8)	4.8 (16.2)

Population analysed: The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned

9 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2.5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ranibizumab	10 of 124 (8.1%)	77 of 124 (62.1%)	Not reported
Dexamethasone	16 of 119 (13.4%)	99 of 119 (83.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Novartis Pharmaceuticals study director

Novartis Pharmaceuticals

64 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ranibizumab in people with Visual Impairment and Macular Edema, run by Novartis Pharmaceuticals at 64 sites in 4 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 3 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 27 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 64 sites in Germany, United Kingdom, Hungary, Poland. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 18 Feb 2015). 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?

Mean Average BCVA Change From Month 1 Through Month 6 to Baseline (time frame: Baseline, month 6). 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 NCT01396083.

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 27 Sep 2016.