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

NCT01396083 | Completed Phase 3 Results

• 2 other identifiers: CRFB002EDE182011-001020-38
• Study Type: interventional
• Target: 243
• Locations: 4 countries
• Sites: 64

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.

Conditions

Visual Impairment; Macular Edema; Central Retinal Vein Occlusion

Keywords

Visual impairment; macular edema; Central retinal vein occlusion; Dexamethasone implant; Ranibizumab

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline, month 6

Secondary Outcomes (9)

• Mean BCVA Change at Month 6

  Baseline, month 6

• Number of Patients Gaining / Losing ≥ 15 / 10 / 5 Letters

  Baseline, 6 month

• Time to Achieve a Significant Improvement ≥ 15 Letters

  Baseline, month 6

• Change Over Time in BCVA

  Baseline, month 6

• Change Over Time of the Central Retinal Thickness (CRT)

  Baseline, month 6

Study Arms (2)

Ranibizumab

EXPERIMENTAL

Drug: Ranibizumab

Standard of Care

ACTIVE COMPARATOR

Drug: Dexamethasone implant and sham injections

Interventions

Ranibizumab DRUG

Ranibizumab

Dexamethasone implant and sham injections DRUG

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (64)

Novartis Investigative Site

Leipzig, Germany, 04103, Germany

Location

Novartis Investigative Site

Regensburg, Germany, 93042, Germany

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Novartis Investigative Site

Augsburg, 85155, Germany

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Novartis Investigative Site

Bad Rothenfelde, 49215, Germany

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Novartis Investigative Site

Berlin, 10713, Germany

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Novartis Investigative Site

Berlin, 13353, Germany

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Novartis Investigative Site

Bonn, 53127, Germany

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Novartis Investigative Site

Bremen, 28209, Germany

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Novartis Investigative Site

Chemnitz, 09116, Germany

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Novartis Investigative Site

Cologne, 50935, Germany

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Novartis Investigative Site

Darmstadt, 64298, Germany

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Novartis Investigative Site

Dortmund, 44137, Germany

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Novartis Investigative Site

Dresden, 01307, Germany

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Novartis Investigative Site

Düsseldorf, 40225, Germany

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Novartis Investigative Site

Frankfurt, 60318, Germany

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Novartis Investigative Site

Freiburg I. Br, 79106, Germany

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Novartis Investigative Site

Glauchau, 08371, Germany

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Novartis Investigative Site

Göttingen, 37075, Germany

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Novartis Investigative Site

Hagen, 58097, Germany

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Novartis Investigative Site

Hamburg, 20246, Germany

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Novartis Investigative Site

Hamburg, 22417, Germany

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Novartis Investigative Site

Homburg, 66421, Germany

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Novartis Investigative Site

Ingolstadt, 85049, Germany

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Novartis Investigative Site

Karlsruhe, 76133, Germany

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Novartis Investigative Site

Karlsruhe, 76199, Germany

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Novartis Investigative Site

Kiel, 24105, Germany

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Novartis Investigative Site

Lauterbach, 36341, Germany

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Novartis Investigative Site

Ludwigshafen, 67063, Germany

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Novartis Investigative Site

Minden, 32427, Germany

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Novartis Investigative Site

Mülheim, 45468, Germany

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Novartis Investigative Site

München, 80336, Germany

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Novartis Investigative Site

München, 81675, Germany

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Novartis Investigative Site

Münster, 48145, Germany

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Novartis Investigative Site

Münster, 48149, Germany

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Novartis Investigative Site

Nuremberg, 90491, Germany

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Novartis Investigative Site

Recklinghausen, 45657, Germany

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Novartis Investigative Site

Sulzbach, 66280, Germany

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Novartis Investigative Site

Tübingen, 72076, Germany

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Novartis Investigative Site

Ulm, 89075, Germany

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Novartis Investigative Site

Wolfsburg, 38442, Germany

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Novartis Investigative Site

Würzburg, 97080, Germany

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Novartis Investigative Site

Budapest, 1083, Hungary

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Novartis Investigative Site

Budapest, 1133, Hungary

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Novartis Investigative Site

Szeged, H-6720, Hungary

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Novartis Investigative Site

Bydgoszcz, Poland

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Novartis Investigative Site

Bytom, 41-902, Poland

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Novartis Investigative Site

Birmingham, B152WB, United Kingdom

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Novartis Investigative Site

Birmingham, B18 7QU, United Kingdom

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Novartis Investigative Site

Bradford, BD9 6RJ, United Kingdom

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Novartis Investigative Site

Cheshire, CW1 4QJ, United Kingdom

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Novartis Investigative Site

Colchester, CO3 3NB, United Kingdom

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Novartis Investigative Site

Derby, DE22 3NE, United Kingdom

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Novartis Investigative Site

Gloucester, GL1 3NN, United Kingdom

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Novartis Investigative Site

Guildford, Surrey, GU2 5XX, United Kingdom

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Novartis Investigative Site

Kent, CT1 3NG, United Kingdom

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Novartis Investigative Site

Leeds, LS9 7TF, United Kingdom

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Novartis Investigative Site

London, SE1 7EH, United Kingdom

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Novartis Investigative Site

Manchester, M13 9WH, United Kingdom

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Novartis Investigative Site

Middlesbrough, TS4 3BW, United Kingdom

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Novartis Investigative Site

Nottingham, NG7 2UH, United Kingdom

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Novartis Investigative Site

Portsmouth, PO6 3LY, United Kingdom

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Novartis Investigative Site

Rugby, CV22 5PX, United Kingdom

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Novartis Investigative Site

Westcliff-on-Sea, SS0 0RY, United Kingdom

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Novartis Investigative Site

York, YO31 8HE, United Kingdom

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MeSH Terms

Conditions

Vision Disorders; Macular Edema; Retinal Vein Occlusion

Interventions

Ranibizumab; Dexamethasone

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Macular Degeneration; Retinal Degeneration; Retinal Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

trialandresults.registries@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2011
• First Posted: July 18, 2011
• Study Start: August 1, 2011
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: September 27, 2016
• Results First Posted: February 18, 2015

Record last verified: 2016-09

Locations

DE (41); HU (3); GB (18); PL (2)