Efficacy and Safety of Ranibizumab 0.5 vs Verteporfin PDT in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia

NCT01922102 | Completed Phase 3 Results

• 1 other identifier: CRFB002F2302
• Study Type: interventional
• Target: 457
• Locations: 6 countries
• Sites: 47

Brief Summary

This study was 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 secondary to pathologic myopia (PM)

Conditions

Visual Impairment Due to Choroidal Neovascularization (CNV) Secondary to Pathologic Myopia (PM)

Keywords

vision loss,PM,CNV,ranibizumab,verteporfinPDT,Brilliance

Outcome Measures

Primary Outcomes (1)

• Change From Baseline BCVA to the Average Level of BCVA Over All Monthly Assessments From Month 1 to Month 3

  Best corrected visual acuity (BCVA) was tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) charts testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts. The overall BCVA score was calculated using the BCVA worksheet, which was kept in the source data and the score was recorded in the eCRF.

  From Baseline to Month 3

Secondary Outcomes (8)

• Change From Baseline BCVA to the Average Level of BCVA Over All Monthly Assessments From Month 1 to Month 6

  From Baseline to Month 6

• The Average Change in BCVA Score From Baseline to Month 1 Through Month 12

  From Baseline to Month 12

• Mean Change From Baseline in Visual Acuity Over Time

  Change from baseline at months 3, 6, and 12

• Categorized BCVA Changes at Months 3, 6 and 12 Compared With Baseline for the Study Eye

  From Baseline to Month 12

• Mean Change From Baseline Over Time in Central Sub-field Thickness (CSFT)

  Baseline, Month 3, Month 6, and Month 12

Study Arms (3)

Group I

EXPERIMENTAL

0.5 mg ranibizumab driven by visual acuity stability criteria

Drug: Ranibizumab 0.5mg

Group II

EXPERIMENTAL

0.5 mg ranibizumab driven by disease activity criteria

Drug: Ranibizumab 0.5 mg

Group III

ACTIVE COMPARATOR

verteporfin PDT

Drug: Verteporfin PDT

Interventions

Ranibizumab 0.5mg DRUG

0.5 mg ranibizumab (intravitreal injections)

Also known as: Lucentis

Group I

Ranibizumab 0.5 mg DRUG

0.5 mg ranibizumab (intravitreal injections)

Also known as: Lucentis

Group II

Verteporfin PDT DRUG

Verteporfin for intravenous injection delivered by intravenous infusion followed by the light application

Also known as: Visudyne

Group III

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 CNV secondary to PM.
• Best corrected visual acuity in the study eye \> 24 and \< 78 ETDRS letters.
• High myopia (\> -6D),
• anterio-posterior elongation \> 26 mm; posterior changes compatible with the pathologic myopia.
• Either CNV locations in the study eye: subfoveal, juxtafoveal, extrafoveal.

You may not qualify if:

• Some preexisting eye disorders or systemic diseases;-Blood pressure \> 150/90 mmHg
• Prior focal/grid laser to the macular area -History of treatment with any anti-VEGF or verteporfin PDT 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 (47)

Novartis Investigative Site

Beijing, Beijing Municipality, 100191, China

Location

Novartis Investigative Site

Beijing, Beijing Municipality, 100730, China

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Novartis Investigative Site

Chongqing, Chongqing Municipality, 400042, China

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Novartis Investigative Site

Shantou, Guangdong, 515041, China

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Novartis Investigative Site

Harbin, Heilongjiang, 150001, China

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Novartis Investigative Site

Wuhan, Hubei, 430060, China

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Novartis Investigative Site

Wuhan, Hubei, 430070, China

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Novartis Investigative Site

Changsha, Hunan, 410008, China

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Novartis Investigative Site

Changsha, Hunan, 410011, China

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Novartis Investigative Site

Nanjing, Jiangsu, 210006, China

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Novartis Investigative Site

Nanjing, Jiangsu, 210029, China

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Novartis Investigative Site

Wuxi, Jiangsu, 214023, China

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Novartis Investigative Site

Nanchang, Jiangxi, 330006, China

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Novartis Investigative Site

Qingdao, Shandong, 266011, China

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Novartis Investigative Site

Xi’an, Shanxi, 710032, China

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Novartis Investigative Site

Chengdu, Sichuan, 610041, China

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Novartis Investigative Site

Tianjin, Tianjin Municipality, 300020, China

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Novartis Investigative Site

Tianjin, Tianjin Municipality, 300070, China

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Novartis Investigative Site

Hangzhou, Zhejiang, 310009, China

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Novartis Investigative Site

Wenzhou, Zhejiang, 325027, China

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Novartis Investigative Site

Beijing, 100034, China

Location

Novartis Investigative Site

Beijing, 100176, China

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Novartis Investigative Site

Beijing, 100730, China

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Novartis Investigative Site

Chongqing, 400038, China

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Novartis Investigative Site

Shanghai, 200080, China

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Novartis Investigative Site

Shanghai, 200092, China

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Novartis Investigative Site

Shanghai, China

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Novartis Investigative Site

Hong Kong, Hong Kong

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Novartis Investigative Site

Chandīgarh, Haryana, 160 030, India

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Novartis Investigative Site

Bangalore, Karnataka, 560 010, India

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Novartis Investigative Site

Vanchiyoor, Kerala, 695035, India

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Novartis Investigative Site

Bhubaneswar, Odisha, 751024, India

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Novartis Investigative Site

Chennai, Tamil Nadu, 600 015, India

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Novartis Investigative Site

Chennai, Tamil Nadu, 600006, India

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Novartis Investigative Site

Coimbatore, Tamil Nadu, 641 014, India

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Novartis Investigative Site

Hyderabad, Telangana, 500 034, India

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Novartis Investigative Site

Angamaly, 683572, India

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Novartis Investigative Site

New Delhi, 110029, India

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Novartis Investigative Site

Manila, National Capital Region, 1000, Philippines

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Novartis Investigative Site

Manila, National Capital Region, 1008, Philippines

Location

Novartis Investigative Site

Pusan, 614 735, South Korea

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Novartis Investigative Site

Seoul, 02841, South Korea

Location

Novartis Investigative Site

Seoul, 03722, South Korea

Location

Novartis Investigative Site

Khon Kaen, THA, 40002, Thailand

Location

Novartis Investigative Site

Bangkok, 10700, Thailand

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Novartis Investigative Site

Chiang Mai, 50200, Thailand

Location

Novartis Investigative Site

Nakornphathom, 73210, Thailand

Location

MeSH Terms

Conditions

Choroidal Neovascularization

Interventions

Ranibizumab; Verteporfin

Condition Hierarchy (Ancestors)

Choroid Diseases; Uveal Diseases; Eye 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; Porphyrins; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

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

Study Record Dates

• First Submitted: August 12, 2013
• First Posted: August 14, 2013
• Study Start: September 11, 2013
• Primary Completion: September 14, 2016
• Study Completion: September 14, 2016
• Last Updated: June 24, 2019
• Results First Posted: June 24, 2019

Record last verified: 2019-03

Locations

HK (1); KR (3); TH (4); CN (27); PH (2); IN (10)