Assess the Efficacy/Safety of Intravitreal Ranibizumab in Patients With Vision Loss Due to Choroidal Neovascularization.

NCT01840410 | Completed Phase 3 Results

• 2 other identifiers: CRFB002G23012012-005417-38
• Study Type: interventional
• Target: 183
• Locations: 21 countries
• Sites: 59

Brief Summary

This study was conducted to evaluate the efficacy and safety of 0.5 mg ranibizumab in adult and adolescent patients with visual impairment due to choridal neovascularization (CNV).

Conditions

Choroidal Neovascularization (CNV)

Keywords

Vision Impairment; Abnormal growth of blood vessels

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Best-corrected Visual Acuity (BCVA) in Study Eye to Month 2

  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. The data were analyzed using mixed model repeated measures (MMRM) which contained scheduled visit, the type of underlying pathophysiologic mechanism (angloid streaks versus others) and treatment group as fixed effect factors, centered baseline BCVA as a continuous covariate and treatment group by visit and visit by centered baseline BCVA interactions. 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

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

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

  Baseline, Month 2, Month 6, Month 12

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

  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 could switch to open-label ranibizumab on an as needed basis.

Other: Sham control

Interventions

Ranibizumab DRUG

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

Ranibizumab

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

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 CNV secondary to any causes with the CNV or its sequelae affecting the fovea;
• BCVA must be between ≥ 24 and ≤ 83 letters in the study eye;
• Visual loss in the study eye should mainly be due to the presence of any eligible types of CNV;

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;
• Active diabetic retinopathy, active ocular/periocular infectious disease or active severe intra-ocular inflammation;
• CNV- conditions with a high likelihood of spontaneous resolution;
• History of intravitreal treatment with steroids;
• History of laser photocoagulation;
• History of intraocular treatment with any anti-angiogenic drugs.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (59)

Novartis Investigative Site

Sydney, New South Wales, 2000, Australia

Location

Novartis Investigative Site

Adelaide, South Australia, 5000, Australia

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Novartis Investigative Site

South Launceston, Tasmania, 7249, Australia

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Novartis Investigative Site

Montreal, Quebec, H1T 2M4, Canada

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Novartis Investigative Site

Hradec Králové, 505 05, Czechia

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Novartis Investigative Site

Prague, 100 34, Czechia

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Novartis Investigative Site

Glostrup Municipality, 2600, Denmark

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Novartis Investigative Site

Paris, France, F-75571, France

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Novartis Investigative Site

Paris, 75010, 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

Bochum, 44892, Germany

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Novartis Investigative Site

Bonn, 53127, 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

Münster, 48145, Germany

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Novartis Investigative Site

Münster, 48149, Germany

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Novartis Investigative Site

Tübingen, 72076, Germany

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Novartis Investigative Site

Pátrai, Greece, 265 00, Greece

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Novartis Investigative Site

Thessaloniki, Greece, GR 56429, Greece

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Novartis Investigative Site

Heraklion Crete, GR, 711 10, Greece

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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

Debrecen, 4043, Hungary

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Novartis Investigative Site

Szeged, H-6720, Hungary

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Novartis Investigative Site

Bari, BA, 70124, Italy

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Novartis Investigative Site

Catania, CT, 95123, Italy

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Novartis Investigative Site

Milan, MI, 20132, Italy

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Novartis Investigative Site

Roma, RM, 00198, Italy

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Novartis Investigative Site

Udine, UD, 33100, Italy

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Novartis Investigative Site

Varese, VA, 21100, Italy

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Novartis Investigative Site

Riga, 1002, Latvia

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Novartis Investigative Site

Kaunas, LTU, 50009, Lithuania

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Novartis Investigative Site

Vilnius, LT-08661, Lithuania

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Novartis Investigative Site

San Isidro, Lima region, 27, Peru

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Novartis Investigative Site

Katowice, 40-594, Poland

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Novartis Investigative Site

Wroclaw, 50-556, Poland

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Novartis Investigative Site

Coimbra, Portugal, 3000-354, Portugal

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Novartis Investigative Site

Porto, Portugal, 4200-319, Portugal

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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, 06591, South Korea

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Novartis Investigative Site

Seoul, Seoul, 150-034, South Korea

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Novartis Investigative Site

Málaga, Andalusia, 29010, 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

Bern, 3010, Switzerland

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Novartis Investigative Site

Binningen, 4102, Switzerland

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Novartis Investigative Site

Lausanne, 1007, Switzerland

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Novartis Investigative Site

Ankara, 06100, Turkey (Türkiye)

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Novartis Investigative Site

Istanbul, 34420, Turkey (Türkiye)

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Novartis Investigative Site

Kocaeli, 41380, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Choroidal Neovascularization; Vision Disorders

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Choroid Diseases; Uveal Diseases; Eye Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; 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 23, 2013
• First Posted: April 25, 2013
• Study Start: September 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: August 26, 2016
• Results First Posted: August 26, 2016

Record last verified: 2016-08

Locations

DK (1); DE (9); CH (3); AU (3); CA (1); RU (3); KR (4); TU (3); FR (2); LI (2); GR (3); PL (2); SG (1); PT (2); ES (3); LA (1); IT (6); SL (2); HU (5); PE (1); CZ (2)