To Assess the Efficacy and Safety of Intravitreal Ranibizumab in People With Vision Loss Due to Macular Edema

NCT01846299 | Completed Phase 3 Results

• 2 other identifiers: CRFB002G23022012-005418-20
• Study Type: interventional
• Target: 181
• Locations: 19 countries
• Sites: 61

Brief Summary

To evaluate the efficacy and safety of 0.5 mg Ranibizumab intravitreal injections in adult patients with visual impairment due to macular edema (ME).

Conditions

Macular Edema (ME)

Keywords

Vision Impairment

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Best-corrected Visual Acuity (BCVA) in Study Eye

  BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. A positive change from baseline indicated improvement.

  Baseline, Month 2

Secondary Outcomes (13)

• Change From Baseline in BCVA in Study Eye up to Month 2

  Baseline, Month 1, Month 2

• Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye

  Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

• Change From Baseline in Central Subfield Volume (CSFV) in Study Eye

  Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

• Number of Participants With Presence or Absence of Intra-retinal Fluid in Study Eye Compared to Baseline

  Month 2, Month 6, Month 12

• Number of Participants With Presence or Absence of Subretinal Fluid in Study Eye Compared to Baseline

  Month 2, Month 6, Month 12

Study Arms (2)

Ranibizumab

EXPERIMENTAL

A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.

Drug: Ranibizumab

Sham control

SHAM COMPARATOR

Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At month 1, if treatment was needed, sham was administered. At month 2, participants switched to open-label ranibizumab on an as needed basis.

Other: Sham control

Interventions

Sham control OTHER

The sham vial did not contain active drug (empty sterile vial). The sham injection was an imitation of an intravitreal injection using an injection syringe without a needle touching the eye.

Sham control

Ranibizumab DRUG

Ranibizumab 0.5mg/0.5mL was administered intravitreally to the participant.

Ranibizumab

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of active ME secondary to any causes (for adult patients: except diabetic macular edema (DME), age-related macular degeneration (AMD) and retinal vein occlusion (RVO));
• BCVA must be between ≥ 24 and ≤ 83 letters;
• Visual loss should be mainly due to the presence of any eligible types of ME.

You may not qualify if:

• Women of child-bearing potential,
• Active malignancies;
• History of stroke less than 6 months prior to screening;
• Uncontrolled systemic inflammation or infection, related directly to the underlying causal disease of ME;
• Active diabetic retinopathy, active ocular/periocular infectious disease or active severe intra-ocular inflammation;
• Any type of advanced, severe or unstable ocular disease or its reatment;
• ME with a high likelihood of spontaneous resolution.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (61)

Novartis Investigative Site

Sydney, New South Wales, 2000, Australia

Location

Novartis Investigative Site

Westmead, New South Wales, 2145, Australia

Location

Novartis Investigative Site

Adelaide, South Australia, 5000, Australia

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Novartis Investigative Site

Hobart, Tasmania, 7000, Australia

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Novartis Investigative Site

South Launceston, Tasmania, 7249, Australia

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Novartis Investigative Site

Leuven, 3000, Belgium

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Novartis Investigative Site

Halifax, Nova Scotia, B3H 2E1, Canada

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Novartis Investigative Site

Pilsen, 301 00, Czechia

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Novartis Investigative Site

Prague, 100 34, Czechia

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Novartis Investigative Site

Bordeaux, France, F-33076, France

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Novartis Investigative Site

Lyon, 69003, France

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Novartis Investigative Site

Paris, 75010, France

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Novartis Investigative Site

Saint-Jean, 31240, France

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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

Düsseldorf, 40225, Germany

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Novartis Investigative Site

Freiburg I. Br, 79106, 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

Debrecen, 4012, Hungary

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Novartis Investigative Site

Szeged, H-6720, Hungary

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Novartis Investigative Site

Jerusalem, 9112001, Israel

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Novartis Investigative Site

Kfar Saba, 4428164, Israel

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Novartis Investigative Site

Petah Tikva, 49100, Israel

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Novartis Investigative Site

Rehovot, 7610001, Israel

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Novartis Investigative Site

Tel Aviv, 6423906, Israel

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Novartis Investigative Site

Florence, FI, 50134, Italy

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Novartis Investigative Site

Genova, GE, 16132, Italy

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Novartis Investigative Site

Milan, MI, 20123, Italy

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Novartis Investigative Site

Pisa, PI, 56124, Italy

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Novartis Investigative Site

Roma, RM, 00133, Italy

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Novartis Investigative Site

Torino, TO, 10122, Italy

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Novartis Investigative Site

Riga, 1002, Latvia

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Novartis Investigative Site

Tilburg, Netherlands, NL-5022GC, Netherlands

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Novartis Investigative Site

Amsterdam, 1105 AZ, Netherlands

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Novartis Investigative Site

Kazan', 420012, Russia

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Novartis Investigative Site

Moscow, 119021, Russia

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Novartis Investigative Site

Moscow, 127486, Russia

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Novartis Investigative Site

Singapore, 168751, Singapore

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Novartis Investigative Site

Banská Bystrica, Slovakia, 97517, Slovakia

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Novartis Investigative Site

Trenčín, Slovakia, 91171, Slovakia

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Novartis Investigative Site

Busan, Busan, 602-739, South Korea

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Novartis Investigative Site

Seoul, Korea, 03080, South Korea

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Novartis Investigative Site

Seoul, Korea, 137-701, South Korea

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Novartis Investigative Site

Seoul, Seoul, 150-034, South Korea

Location

Novartis Investigative Site

Málaga, Andalusia, 29010, Spain

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Novartis Investigative Site

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

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Novartis Investigative Site

Valladolid, Castille and León, 47011, Spain

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Novartis Investigative Site

Sant Cugat del Vallès, Catalonia, 08190, Spain

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Novartis Investigative Site

Zurich, Switzerland, 8063, Switzerland

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Novartis Investigative Site

Bern, 3010, Switzerland

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Novartis Investigative Site

Binningen, 4102, Switzerland

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Novartis Investigative Site

Ankara, 06100, Turkey (Türkiye)

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Novartis Investigative Site

Kocaeli, 41380, Turkey (Türkiye)

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Novartis Investigative Site

Frimley, Surrey, GU16 7UJ, United Kingdom

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Novartis Investigative Site

London, United Kingdom, EC1V 2PD, United Kingdom

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Novartis Investigative Site

Birmingham, B18 7QU, United Kingdom

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Novartis Investigative Site

Bristol, BS1 2LX, United Kingdom

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Novartis Investigative Site

Manchester, M13 9WL, United Kingdom

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Novartis Investigative Site

Southampton, SO16 6YD, United Kingdom

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Novartis Investigative Site

Sunderland, SR2 9HP, United Kingdom

Location

MeSH Terms

Conditions

Macular Edema; Vision Disorders

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Study Director
• Organization: Novartis

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: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2013
• First Posted: May 3, 2013
• Study Start: October 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: May 23, 2016
• Results First Posted: May 23, 2016

Record last verified: 2016-04

Locations

CZ (2); RU (3); IL (5); HU (4); LA (1); SL (2); ES (4); CH (3); TU (2); KR (4); AU (5); IT (6); DE (4); NL (2); BE (1); FR (4); CA (1); GB (7); SG (1)