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

NCT01396057 | Completed Phase 3 Results

• 2 other identifiers: CRFB002EDE172011-001019-30
• Study Type: interventional
• Target: 244
• Locations: 5 countries
• Sites: 66

Brief Summary

This clinical trial is designed to compare ranibizumab in comparison with Dexamethasone implant after 6 months of treatment. In the study arm Ranibizumab 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; Branch Retinal Vein Occlusion

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Mean Average Best Corrected Visual Acuity (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

  Baseline, month 6

Secondary Outcomes (9)

• Mean BCVA Change From Baseline to Endpoints Month 1 to Month 6

  Baseline, month 6

• Percentage of Patients Gaining / Losing ≥ 15 / 10 / 5 Letters After 6 Month Treatment

  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

Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally

Drug: Ranibizumab

Dexamethasone

SHAM COMPARATOR

Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months

Other: Dexamethasone Implant; Other: Sham injection

Interventions

Ranibizumab DRUG

Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally. Ranibizumab was formulated as a sterile solution aseptically filled in a sterile glass vial. It was suitable for single use only and the content of the vial was not allowed to be split

Ranibizumab

Dexamethasone Implant OTHER

Comparator Ozurdex® (dexamethasone) was formulated as a rod shaped implant to be inserted into the eye by an applicator. The implant as well as the respective applicator were suitable for single use only.

Dexamethasone

Sham injection OTHER

Sham injection: Empty sterile syringes were provided so that masking could be maintained. Either empty syringes in the case of sham injections or pre-filled syringes in the case of ranibizumab injections were visible to the patient in the room of study drug administration

Dexamethasone

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 BRVO
• Diagnosis of BRVO 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 (66)

Novartis Investigative Site

Prague, 100 34, Czechia

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Novartis Investigative Site

Leipzig, Germany, 04103, Germany

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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

Bochum, 44791, Germany

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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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Darmstadt, 64298, Germany

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Novartis Investigative Site

Dresden, 01257, Germany

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Novartis Investigative Site

Düsseldorf, 40212, Germany

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Novartis Investigative Site

Düsseldorf, 40225, Germany

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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

Halle, 06114, 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

Ludwigshafen, 67063, Germany

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Novartis Investigative Site

Marburg, 35039, Germany

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Novartis Investigative Site

Minden, 32427, Germany

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Munich, 80336, Germany

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Mülheim, 45468, Germany

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München, 81675, Germany

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Novartis Investigative Site

Münster, 48145, Germany

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Münster, 48149, Germany

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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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Budapest, 1083, Hungary

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Debrecen, 4004, Hungary

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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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Birmingham, B18 7QU, United Kingdom

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Bradford, BD9 6RJ, United Kingdom

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Novartis Investigative Site

Cheshire, CW14QJ, 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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Related Publications (1)

• Shalchi Z, Mahroo O, Bunce C, Mitry D. Anti-vascular endothelial growth factor for macular oedema secondary to branch retinal vein occlusion. Cochrane Database Syst Rev. 2020 Jul 7;7(7):CD009510. doi: 10.1002/14651858.CD009510.pub3.

  PMID: 32633861 DERIVED

MeSH Terms

Conditions

Vision Disorders; Macular Edema; Retinal Vein Occlusion

Interventions

Ranibizumab; Dexamethasone; salicylhydroxamic acid

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: July 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: August 7, 2014
• Results First Posted: July 16, 2014

Record last verified: 2014-08

Locations

PL (2); DE (42); HU (3); CZ (1); GB (18)