Efficacy and Safety of Ranibizumab in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia

NCT01217944 | Completed Phase 3 Results

• 2 other identifiers: CRFB002F23012010-021662-30
• Study Type: interventional
• Target: 277
• Locations: 20 countries
• Sites: 74

Brief Summary

This study is designed to evaluate the efficacy and safety of two different dosing regimens of 0.5 mg ranibizumab given as intravitreal injection in comparison to verteporfin PDT in patients with visual impairment due to choroidal neovascularization (CNV) secondary to pathologic myopia (PM).

Conditions

Pathological Myopia

Keywords

Pathologic myopia; PM; choroidal neovascularization; CNV; ranibizumab; verteporfin PDT

Outcome Measures

Primary Outcomes (1)

• Average Change From Baseline to Month 1 Through Month 3 on Visual Acuity of the Study Eye

  The Best Corrected Visual Acuity (BCVA) was tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts at baseline and compared to the average from month 1 to month 3.

  Baseline, Month 1 through Month 3

Secondary Outcomes (11)

• Average Change From Baseline to Month 6 in Visual Acuity of the Study Eye

  Baseline and Month 6

• Average Change From Baseline to Month 1 Through Month 12 in Visual Acuity of the Study Eye

  Baseline and Month 1 through Month 12

• Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letters Gain or Reach 84 Letters at Month 3

  Month 3

• Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letters Gain or Reach 84 Letters at Month 6 and Month 12

  Months 6 and 12

• Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letter Loss at Month 3

  Month 3

Study Arms (3)

Ranibizumab driven by disease activity

EXPERIMENTAL

Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria

Drug: Ranibizumab; Drug: Sham Ranibizumab; Drug: Sham verteporfin PDT

Ranibizumab driven by stabilization criteria

EXPERIMENTAL

Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity

Drug: Ranibizumab; Drug: Sham Ranibizumab; Drug: Sham verteporfin PDT

Verteporfin PDT

ACTIVE COMPARATOR

Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.

Drug: Ranibizumab; Drug: Verteporfin PDT; Drug: Sham Ranibizumab; Drug: Sham verteporfin PDT

Interventions

Ranibizumab DRUG

0.5 mg ranibizumab intravitreal injection

Ranibizumab driven by disease activity; Ranibizumab driven by stabilization criteria; Verteporfin PDT

Verteporfin PDT DRUG

Verteporfin (6 mg/m2) intravenous infusion

Also known as: vPDT

Verteporfin PDT

Sham Ranibizumab DRUG

Empty vial to mimic the intravitreal injection

Ranibizumab driven by disease activity; Ranibizumab driven by stabilization criteria; Verteporfin PDT

Sham verteporfin PDT DRUG

Sham vPDT intravenous infusion of dextrose 5% solution followed by light application (PDT).

Ranibizumab driven by disease activity; Ranibizumab driven by stabilization criteria; Verteporfin PDT

Eligibility Criteria

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

You may qualify if:

• Visual impairment due to choroidal neovascularization (CNV) secondary to PM
• Best corrected visual acuity (BCVA) in the study eye \> 24 and \< 78 Early Treatment Diabetic Retinopathy Study (ETDRS) letters
• High myopia (\> -6D), anterior-posterior elongation \> 26 mm; posterior changes compatible with the pathologic myopia
• Either lesion types in the study eye: subfoveal, juxtafoveal, extrafoveal

You may not qualify if:

• Patients with uncontrolled systemic or ocular diseases
• Blood pressure \> 150/90 mmHg
• History of pan-retinal, focal/grid laser photocoagulation or intraocular treatment with any anti-VEGF or vPDT in the study eye
• Intravitreal treatment with corticosteroids or intraocular surgery within last 3 months in the study eye

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (74)

Novartis Investigative Site

Vienna, Austria, 1090, Austria

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Novartis Investigative Site

Linz, Upper Austria, 4021, Austria

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Vancouver, British Columbia, V5Z 3N9, Canada

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Montreal, Quebec, H1T 2M4, Canada

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Bordeaux, France, F-33076, France

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Dijon, 21033, France

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Paris, 75015, France

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Reims, 51092, France

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Toulouse, 31059, France

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Berlin, 13353, Germany

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Bonn, 53127, Germany

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Cologne, 50924, Germany

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Freiburg im Breisgau, 79106, Germany

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Hamburg, 20246, Germany

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München, 81675, Germany

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Münster, 48145, Germany

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Münster, 48149, Germany

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Nuremberg, 90491, Germany

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Regensburg, 93053, Germany

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Hong Kong, Hong Kong, Hong Kong

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Budapest, 1083, Hungary

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Debrecen, 4004, Hungary

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Mumbai, Maharashtra, 400031, India

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New Delhi, New Delhi, 110 029, India

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Chennai, Tamil Nadu, 600006, India

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Madurai, Tamil Nadu, 625020, India

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Bangalore, 560010, India

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Bari, BA, 70124, Italy

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Florence, FI, 50134, Italy

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Milan, MI, 20132, Italy

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Milan, MI, 20157, Italy

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Udine, UD, 33100, Italy

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Nagoya, Aichi-ken, 466-8560, Japan

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Nagoya, Aichi-ken, 467-8602, Japan

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Fukuoka, Fukuoka, 812-8582, Japan

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Fukushima, Fukushima, 960-1295, Japan

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Sapporo, Hokkaido, 060-8648, Japan

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Kita-gun, Kagawa-ken, 761-0793, Japan

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Kyoto, Kyoto, 606-8507, Japan

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Matsumoto, Nagano, 390-8621, Japan

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Hirakata, Osaka, 573-1191, Japan

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Suita, Osaka, 565-0871, Japan

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Bunkyo-ku, Tokyo, 113-8519, Japan

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Bunkyo-ku, Tokyo, 113-8655, Japan

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Chiyoda-ku, Tokyo, 101-8309, Japan

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Mitaka, Tokyo, 181-8611, Japan

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Novartis Investigative Site

Riga, 1002, Latvia

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Kaunas, LT-50009, Lithuania

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Vilnius, LT-08661, Lithuania

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Bielsko-Biala, 43-300, Poland

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Coimbra, 3000-075, Portugal

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Porto, 4200-319, Portugal

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Singapore, Singapore, 308433, Singapore

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Singapore, Singapore, 768825, Singapore

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Singapore, 168751, Singapore

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Banská Bystrica, Slovak Republic, 975 17, Slovakia

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Bratislava, Slovakia, 82606, Slovakia

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Seoul, Korea, 110 744, South Korea

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Seoul, Korea, 120-752, South Korea

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Seoul, Korea, 135-710, South Korea

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Seoul, 738-736, South Korea

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Bilbao, Basque Country, 48006, Spain

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Valladolid, Castille and León, 47011, Spain

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L'Hospitalet de Llobregat, Catalonia, 08907, Spain

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Alicante, Valencia, 03016, Spain

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Bern, 3010, Switzerland

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Geneva, 1204, Switzerland

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Lausanne, 1007, Switzerland

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Novartis Investigative Site

Ankara, Turkey, 06100, Turkey (Türkiye)

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Novartis Investigative Site

Ankara, Turkey, 06490, Turkey (Türkiye)

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Novartis Investigative Site

Etlik / Ankara, 06018, Turkey (Türkiye)

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Belfast, BT12 6BA, United Kingdom

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Bristol, BS1 2LX, United Kingdom

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Novartis Investigative Site

Wolverhampton, WV10 0QP, United Kingdom

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Related Publications (2)

• Ceklic L, Wolf-Schnurrbusch U, Gekkieva M, Wolf S. Visual acuity outcome in RADIANCE study patients with dome-shaped macular features. Ophthalmology. 2014 Nov;121(11):2288-9. doi: 10.1016/j.ophtha.2014.06.012. Epub 2014 Aug 8. No abstract available.

  PMID: 25109929 DERIVED

• Wolf S, Balciuniene VJ, Laganovska G, Menchini U, Ohno-Matsui K, Sharma T, Wong TY, Silva R, Pilz S, Gekkieva M; RADIANCE Study Group. RADIANCE: a randomized controlled study of ranibizumab in patients with choroidal neovascularization secondary to pathologic myopia. Ophthalmology. 2014 Mar;121(3):682-92.e2. doi: 10.1016/j.ophtha.2013.10.023. Epub 2013 Dec 8.

  PMID: 24326106 DERIVED

MeSH Terms

Conditions

Myopia, Degenerative; Choroidal Neovascularization

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Myopia; Refractive Errors; Eye Diseases; Choroid Diseases; Uveal Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; 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 Pharmaceuticals

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: October 6, 2010
• First Posted: October 8, 2010
• Study Start: October 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: February 10, 2014
• Results First Posted: October 18, 2013

Record last verified: 2014-01

Locations

HU (2); TU (3); PL (1); FR (5); CH (3); CA (2); AU (2); GB (3); ES (4); HK (1); IT (5); LA (1); PT (2); DE (10); JP (14); SL (2); LI (2); KR (4); SG (3); IN (5)