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

Primary Purpose

Pathological Myopia

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Ranibizumab

Verteporfin PDT

Sham Ranibizumab

Sham verteporfin PDT

About this trial

This is an interventional treatment trial for Pathological Myopia focused on measuring Pathologic myopia, PM, choroidal neovascularization, CNV, ranibizumab, verteporfin PDT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Other protocol-defined inclusion/exclusion criteria may apply

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Ranibizumab driven by disease activity

Ranibizumab driven by stabilization criteria

Verteporfin PDT

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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

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

BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained more than 10 or more than 15 of visual acuity at 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

BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained more than 10 or more than 15 letters of visual acuity at month 6 and month 12.

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

BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. A decreased score indicates worsening in acuity. This outcome assessed the percentage of participants who lost more than 10 or more than 15 of visual acuity at month 3.

Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letter Loss at Month 6 and 12

BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. A decreased score indicates worsening in acuity. This outcome assessed the percentage of participants who lost more than 10 or more than 15 of visual acuity at month 6 and 12.

Change From Baseline in Central Retinal Thickness of the Study Eye Over Time

Retinal thickness was measured by Central Reading Center using patient's Optical Coherence Tomography (OCT) images provided by investigators.

Percentage of Patients With Choroidal Neovascularization (CNV) Leakage in the Study Eye

CNV leakage assessment plus other choroid and retinal disorders were assessed by Central Reading Center using patient's fluorescein angiography and color fundus photography images provided by investigators.

Number of Ranibizumab Injections Received Prior to Month 3

In order to describe exposure to the study drug the number of ejections was evaluated

Number of Ranibizumab Injections Received by Patients Randomized to the Ranibizumab Groups, by Period

Number of ranibizumab injections received by patients randomized to the ranibizumab groups, by period

Number of Ranibizumab Injections Received by Patients Randomized to vPDT With Ranibizumab From Month 3 by Period

Number of ranibizumab injections received by patients randomized to the vPDT with ranibizumab groups, by period.

Full Information

NCT ID

NCT01217944

First Posted

October 6, 2010

Last Updated

January 14, 2014

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01217944

Brief Title

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

Official Title

A 12 Month, Phase III, Randomized, Double-masked, Multicenter, Active-controlled Study to Evaluate the Efficacy and Safety of Two Different Dosing Regimens of 0.5 mg Ranibizumab vs. Verteporfin PDT in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Completed

Study Start Date

October 2010 (undefined)

Primary Completion Date

August 2012 (Actual)

Study Completion Date

August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pathological Myopia

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

277 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ranibizumab driven by disease activity

Arm Type

Experimental

Arm Description

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

Arm Title

Ranibizumab driven by stabilization criteria

Arm Type

Experimental

Arm Description

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

Arm Title

Verteporfin PDT

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Ranibizumab

Intervention Description

0.5 mg ranibizumab intravitreal injection

Intervention Type

Drug

Intervention Name(s)

Verteporfin PDT

Other Intervention Name(s)

vPDT

Intervention Description

Verteporfin (6 mg/m2) intravenous infusion

Intervention Type

Drug

Intervention Name(s)

Sham Ranibizumab

Intervention Description

Empty vial to mimic the intravitreal injection

Intervention Type

Drug

Intervention Name(s)

Sham verteporfin PDT

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Baseline, Month 1 through Month 3

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

Baseline and Month 6

Title

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

Description

Time Frame

Baseline and Month 1 through Month 12

Title

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

Description

Time Frame

Month 3

Title

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

Description

BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained more than 10 or more than 15 letters of visual acuity at month 6 and month 12.

Time Frame

Months 6 and 12

Title

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

Description

BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. A decreased score indicates worsening in acuity. This outcome assessed the percentage of participants who lost more than 10 or more than 15 of visual acuity at month 3.

Time Frame

Month 3

Title

Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letter Loss at Month 6 and 12

Description

BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. A decreased score indicates worsening in acuity. This outcome assessed the percentage of participants who lost more than 10 or more than 15 of visual acuity at month 6 and 12.

Time Frame

Months 6 and 12

Title

Change From Baseline in Central Retinal Thickness of the Study Eye Over Time

Description

Retinal thickness was measured by Central Reading Center using patient's Optical Coherence Tomography (OCT) images provided by investigators.

Time Frame

Baseline, Month 3, Month 6 and Month 12

Title

Percentage of Patients With Choroidal Neovascularization (CNV) Leakage in the Study Eye

Description

Time Frame

Baseline and Month 12

Title

Number of Ranibizumab Injections Received Prior to Month 3

Description

In order to describe exposure to the study drug the number of ejections was evaluated

Time Frame

Day 1 and prior to month 3

Title

Number of Ranibizumab Injections Received by Patients Randomized to the Ranibizumab Groups, by Period

Description

Number of ranibizumab injections received by patients randomized to the ranibizumab groups, by period

Time Frame

Day 1 prior to month 6 and prior to month 12

Title

Number of Ranibizumab Injections Received by Patients Randomized to vPDT With Ranibizumab From Month 3 by Period

Description

Number of ranibizumab injections received by patients randomized to the vPDT with ranibizumab groups, by period.

Time Frame

Month 3 up to month 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 Other protocol-defined inclusion/exclusion criteria may apply

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Linz

State/Province

Upper Austria

ZIP/Postal Code

4021

Country

Austria

Facility Name

Novartis Investigative Site

City

Wien

ZIP/Postal Code

1090

Country

Austria

Facility Name

Novartis Investigative Site

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 3N9

Country

Canada

Facility Name

Novartis Investigative Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H1T 2M4

Country

Canada

Facility Name

Novartis Investigative Site

City

Bordeaux Cedex

ZIP/Postal Code

F-33076

Country

France

Facility Name

Novartis Investigative Site

City

Dijon

ZIP/Postal Code

21033

Country

France

Facility Name

Novartis Investigative Site

City

Paris

ZIP/Postal Code

75015

Country

France

Facility Name

Novartis Investigative Site

City

Reims

ZIP/Postal Code

51092

Country

France

Facility Name

Novartis Investigative Site

City

Toulouse

ZIP/Postal Code

31059

Country

France

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

13353

Country

Germany

Facility Name

Novartis Investigative Site

City

Bonn

ZIP/Postal Code

53127

Country

Germany

Facility Name

Novartis Investigative Site

City

Freiburg

ZIP/Postal Code

79106

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

Novartis Investigative Site

City

Koeln

ZIP/Postal Code

50924

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenster

ZIP/Postal Code

48145

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenster

ZIP/Postal Code

48149

Country

Germany

Facility Name

Novartis Investigative Site

City

München

ZIP/Postal Code

81675

Country

Germany

Facility Name

Novartis Investigative Site

City

Nuernberg

ZIP/Postal Code

90491

Country

Germany

Facility Name

Novartis Investigative Site

City

Regensburg

ZIP/Postal Code

93053

Country

Germany

Facility Name

Novartis Investigative Site

City

Hongkong

Country

Hong Kong

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1083

Country

Hungary

Facility Name

Novartis Investigative Site

City

Debrecen

ZIP/Postal Code

4004

Country

Hungary

Facility Name

Novartis Investigative Site

City

Mumbai

State/Province

Maharashtra

ZIP/Postal Code

400031

Country

India

Facility Name

Novartis Investigative Site

City

Chennai

State/Province

Tamil Nadu

ZIP/Postal Code

600006

Country

India

Facility Name

Novartis Investigative Site

City

Madurai

State/Province

Tamil Nadu

ZIP/Postal Code

625020

Country

India

Facility Name

Novartis Investigative Site

City

Bangalore

ZIP/Postal Code

560010

Country

India

Facility Name

Novartis Investigative Site

City

New Delhi

ZIP/Postal Code

110 029

Country

India

Facility Name

Novartis Investigative Site

City

Bari

State/Province

ZIP/Postal Code

70124

Country

Italy

Facility Name

Novartis Investigative Site

City

Firenze

State/Province

ZIP/Postal Code

50134

Country

Italy

Facility Name

Novartis Investigative Site

City

Milano

State/Province

ZIP/Postal Code

20132

Country

Italy

Facility Name

Novartis Investigative Site

City

Milano

State/Province

ZIP/Postal Code

20157

Country

Italy

Facility Name

Novartis Investigative Site

City

Udine

State/Province

ZIP/Postal Code

33100

Country

Italy

Facility Name

Novartis Investigative Site

City

Nagoya-city

State/Province

Aichi

ZIP/Postal Code

466-8560

Country

Japan

Facility Name

Novartis Investigative Site

City

Nagoya-city

State/Province

Aichi

ZIP/Postal Code

467-8602

Country

Japan

Facility Name

Novartis Investigative Site

City

Fukuoka-city

State/Province

Fukuoka

ZIP/Postal Code

812-8582

Country

Japan

Facility Name

Novartis Investigative Site

City

Fukushima-city

State/Province

Fukushima

ZIP/Postal Code

960-1295

Country

Japan

Facility Name

Novartis Investigative Site

City

Sapporo-city

State/Province

Hokkaido

ZIP/Postal Code

060-8648

Country

Japan

Facility Name

Novartis Investigative Site

City

Kita-gun

State/Province

Kagawa

ZIP/Postal Code

761-0793

Country

Japan

Facility Name

Novartis Investigative Site

City

Matsumoto

State/Province

Nagano

ZIP/Postal Code

390-8621

Country

Japan

Facility Name

Novartis Investigative Site

City

Hirakata-city

State/Province

Osaka

ZIP/Postal Code

573-1191

Country

Japan

Facility Name

Novartis Investigative Site

City

Suita-city

State/Province

Osaka

ZIP/Postal Code

565-0871

Country

Japan

Facility Name

Novartis Investigative Site

City

Bunkyo-ku

State/Province

Tokyo

ZIP/Postal Code

113-8519

Country

Japan

Facility Name

Novartis Investigative Site

City

Bunkyo-ku

State/Province

Tokyo

ZIP/Postal Code

113-8655

Country

Japan

Facility Name

Novartis Investigative Site

City

Chiyoda-ku

State/Province

Tokyo

ZIP/Postal Code

101-8309

Country

Japan

Facility Name

Novartis Investigative Site

City

Mitaka-city

State/Province

Tokyo

ZIP/Postal Code

181-8611

Country

Japan

Facility Name

Novartis Investigative Site

City

Kyoto

ZIP/Postal Code

606-8507

Country

Japan

Facility Name

Novartis Investigative Site

City

Seoul

State/Province

Korea

ZIP/Postal Code

110 744

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

State/Province

Korea

ZIP/Postal Code

120-752

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

State/Province

Korea

ZIP/Postal Code

135-710

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

738-736

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Riga

ZIP/Postal Code

1002

Country

Latvia

Facility Name

Novartis Investigative Site

City

Kaunas

ZIP/Postal Code

LT-50009

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Vilnius

ZIP/Postal Code

LT-08661

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Bielsko-Biala

ZIP/Postal Code

43-300

Country

Poland

Facility Name

Novartis Investigative Site

City

Coimbra

ZIP/Postal Code

3000-075

Country

Portugal

Facility Name

Novartis Investigative Site

City

Porto

ZIP/Postal Code

4200-319

Country

Portugal

Facility Name

Novartis Investigative Site

City

Singapore

ZIP/Postal Code

168751

Country

Singapore

Facility Name

Novartis Investigative Site

City

Singapore

ZIP/Postal Code

308433

Country

Singapore

Facility Name

Novartis Investigative Site

City

Singapore

ZIP/Postal Code

768825

Country

Singapore

Facility Name

Novartis Investigative Site

City

Banska Bystrica

State/Province

Slovak Republic

ZIP/Postal Code

975 17

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Bratislava

ZIP/Postal Code

82606

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Valladolid

State/Province

Castilla y Leon

ZIP/Postal Code

47011

Country

Spain

Facility Name

Novartis Investigative Site

City

Hospitalet de Llobregat

State/Province

Cataluña

ZIP/Postal Code

08907

Country

Spain

Facility Name

Novartis Investigative Site

City

Alicante

State/Province

Comunidad Valenciana

ZIP/Postal Code

03016

Country

Spain

Facility Name

Novartis Investigative Site

City

Bilbao

State/Province

Pais Vasco

ZIP/Postal Code

48006

Country

Spain

Facility Name

Novartis Investigative Site

City

Bern

ZIP/Postal Code

3010

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Genève

ZIP/Postal Code

1204

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Lausanne

ZIP/Postal Code

1007

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Ankara

ZIP/Postal Code

06100

Country

Turkey

Facility Name

Novartis Investigative Site

City

Ankara

ZIP/Postal Code

06490

Country

Turkey

Facility Name

Novartis Investigative Site

City

Etlik / Ankara

ZIP/Postal Code

06018

Country

Turkey

Facility Name

Novartis Investigative Site

City

Belfast

ZIP/Postal Code

BT12 6BA

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Bristol

ZIP/Postal Code

BS1 2LX

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Wolverhampton

ZIP/Postal Code

WV10 0QP

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

25109929

Citation

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.

Results Reference

derived

PubMed Identifier

24326106

Citation

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.

Results Reference

derived

Learn more about this trial

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

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

Pathological Myopia

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial