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

This study is currently recruiting participants.

Verified March 2013 by Novartis

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

ClinicalTrials.gov Identifier:

NCT01396083

First received: July 14, 2011

Last updated: March 28, 2013

Last verified: March 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

July 14, 2011

Last Updated Date

March 28, 2013

Start Date ^ICMJE

August 2011

Estimated Primary Completion Date

October 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Measure: mean average BCVA change from Month 1 through Month 6 to Baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01396083 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Measure: mean BCVA change at Month 6 [ Time Frame: 6 month ] [ Designated as safety issue: No ]
Measure: percentage of patients gaining / losing ≥ 15 / 10 / 5 letters [ Time Frame: 6 month ] [ Designated as safety issue: No ]
Measure: time to achieve a significant improvement ≥ 15 letters [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Measure: change over time of the central retinal thickness [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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)

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Visual Impairment
Macular Edema
Central Retinal Vein Occlusion

Intervention ^ICMJE

Drug: Ranibizumab
Drug: Dexamethasone implant and sham injections

Study Arm (s)

Experimental: Ranibizumab
Intervention: Drug: Ranibizumab
Active Comparator: Standard of Care
Intervention: Drug: Dexamethasone implant and sham injections

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

240

Estimated Completion Date

October 2013

Estimated Primary Completion Date

October 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Novartis Pharmaceuticals	+41613241111
Contact: Novartis Pharmaceuticals

Location Countries ^ICMJE

Czech Republic, Germany, Hungary, Poland, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT01396083

Other Study ID Numbers ^ICMJE

CRFB002EDE18, 2011-001020-38

Has Data Monitoring Committee

Not Provided

Responsible Party

Novartis ( Novartis Pharmaceuticals )

Study Sponsor ^ICMJE

Novartis Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

March 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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