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

Primary Purpose

Choroidal Neovascularization (CNV)

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ranibizumab
Sham control
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Choroidal Neovascularization (CNV) focused on measuring Vision Impairment, Abnormal growth of blood vessels

Eligibility Criteria

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

Key Inclusion Criteria:

  • 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;

Key Exclusion Criteria:

  • 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.

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Ranibizumab

Sham control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change From Baseline in BCVA in Study Eye up 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 analysis of covariance (ANCOVA) model which contained the type of underlying pathophysiologic mechanism (angloid streaks versus others) and treatment group as fixed effect factors, centered baseline BCVA as a continuous covariate. A positive change from baseline indicated improvement.
Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye
CSFT was assessed by optical coherence tomography (OCT). A negative change from baseline indicates improvement.
Change From Baseline in Central Subfield Volume (CSFV) in Study Eye
CSFV was assessed OCT. A negative change from baseline indicates improvement.
Number of Participants With Presence of Intra-retinal Fluid in Study Eye Compared to Baseline
The presence of intra-retinal fluid was assessed by OCT.
Number of Participants With Presence of Subretinal Fluid in Study Eye Compared to Baseline
Presence of subretinal fluid in study eye compared to baseline
Number of Participants With Presence of Active Chorioretinal Leakage
The presence of active chorioretinal leakage was assessed by photography imaging, i.e. fluorescein angiography (FA).
Average Change From Baseline in BCVA
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. BCVA was assessed at each month from Month 1 through Month 6 or at each month from Month 1 through month 12, and the data were averaged. The outcome measure is reporting the change between baseline and average BCVA from Month 1 through Month 6 or from Month 1 through Month 12 (average BCVA - baseline BCVA). A positive change from baseline indicated improvement.
Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters
VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using ETDRS-like visual acuity testing charts at a testing distance of 4 meters.
Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss
VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using ETDRS-like visual acuity testing charts at a testing distance of 4 meters.
Number of Participants With Requirement for Rescue Treatment at Month 1
Rescue treatment with laser photocoagulation or periocular treatment could be administered at Month 1 only if the participant had a visual acuity loss of > 5 letters due to disease activity from baseline to Month 1.
Number of Participants With Ranibizumab Treatments in Study Eye
The number of participants administered study treatments, according to treatment frequency, was assessed.
Number of Participants With Re-treatments
The number of participants, administered re-treatments according to treatment frequency, was assessed. Re-treatment was defined as an administration of study medication following at least one non-missed visit where treatment was not administered in the study eye. Up to month 12, the maximum number of retreatments was 5.
Number of Primary Reasons for Decision to Treat by Investigator
The total number of primary reasons for decisions to treat was assessed. A single participant could have had multiple primary reasons for treatment.

Full Information

First Posted
April 23, 2013
Last Updated
August 15, 2016
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01840410
Brief Title
Assess the Efficacy/Safety of Intravitreal Ranibizumab in Patients With Vision Loss Due to Choroidal Neovascularization.
Official Title
A 12-month, Randomized, Double-masked, Sham-controlled, Multicenter Study to Evaluate the Efficacy and Safety of 0.5mg Ranibizumab Intravitreal Injections in Patients With Visual Impairment Due to Vascular Endothelial Growth Factor (VEGF) Driven Choroidal Neovascularization.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Choroidal Neovascularization (CNV)
Keywords
Vision Impairment, Abnormal growth of blood vessels

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
183 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ranibizumab
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham control
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Intervention Description
Ranibizumab 0.5mg/0.5mL was administered intravitreally to the participant.
Intervention Type
Other
Intervention Name(s)
Sham control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change From Baseline in Best-corrected Visual Acuity (BCVA) in Study Eye to Month 2
Description
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.
Time Frame
Baseline, Month 2
Secondary Outcome Measure Information:
Title
Change From Baseline in BCVA in Study Eye up to Month 2
Description
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 analysis of covariance (ANCOVA) model which contained the type of underlying pathophysiologic mechanism (angloid streaks versus others) and treatment group as fixed effect factors, centered baseline BCVA as a continuous covariate. A positive change from baseline indicated improvement.
Time Frame
Baseline, Month 1, Month 2
Title
Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye
Description
CSFT was assessed by optical coherence tomography (OCT). A negative change from baseline indicates improvement.
Time Frame
Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Title
Change From Baseline in Central Subfield Volume (CSFV) in Study Eye
Description
CSFV was assessed OCT. A negative change from baseline indicates improvement.
Time Frame
Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Title
Number of Participants With Presence of Intra-retinal Fluid in Study Eye Compared to Baseline
Description
The presence of intra-retinal fluid was assessed by OCT.
Time Frame
Baseline, Month 2, Month 6, Month 12
Title
Number of Participants With Presence of Subretinal Fluid in Study Eye Compared to Baseline
Description
Presence of subretinal fluid in study eye compared to baseline
Time Frame
Baseline, Month 2, Month 6, Month 12
Title
Number of Participants With Presence of Active Chorioretinal Leakage
Description
The presence of active chorioretinal leakage was assessed by photography imaging, i.e. fluorescein angiography (FA).
Time Frame
Baseline, Month 2, Month 6, Month 12
Title
Average Change From Baseline in BCVA
Description
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. BCVA was assessed at each month from Month 1 through Month 6 or at each month from Month 1 through month 12, and the data were averaged. The outcome measure is reporting the change between baseline and average BCVA from Month 1 through Month 6 or from Month 1 through Month 12 (average BCVA - baseline BCVA). A positive change from baseline indicated improvement.
Time Frame
Baseline (BL), Month 1 through Month 6, Month 1 through Month 12
Title
Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters
Description
VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using ETDRS-like visual acuity testing charts at a testing distance of 4 meters.
Time Frame
Month 2, Month 6, Month 12
Title
Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss
Description
VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using ETDRS-like visual acuity testing charts at a testing distance of 4 meters.
Time Frame
Month 2, Month 6, Month 12
Title
Number of Participants With Requirement for Rescue Treatment at Month 1
Description
Rescue treatment with laser photocoagulation or periocular treatment could be administered at Month 1 only if the participant had a visual acuity loss of > 5 letters due to disease activity from baseline to Month 1.
Time Frame
Month 1
Title
Number of Participants With Ranibizumab Treatments in Study Eye
Description
The number of participants administered study treatments, according to treatment frequency, was assessed.
Time Frame
Month 12
Title
Number of Participants With Re-treatments
Description
The number of participants, administered re-treatments according to treatment frequency, was assessed. Re-treatment was defined as an administration of study medication following at least one non-missed visit where treatment was not administered in the study eye. Up to month 12, the maximum number of retreatments was 5.
Time Frame
Month 12
Title
Number of Primary Reasons for Decision to Treat by Investigator
Description
The total number of primary reasons for decisions to treat was assessed. A single participant could have had multiple primary reasons for treatment.
Time Frame
Month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: 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; Key Exclusion Criteria: 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.
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
Sydney
State/Province
New South Wales
ZIP/Postal Code
2000
Country
Australia
Facility Name
Novartis Investigative Site
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Novartis Investigative Site
City
South Launceston
State/Province
Tasmania
ZIP/Postal Code
7249
Country
Australia
Facility Name
Novartis Investigative Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Novartis Investigative Site
City
Hradec Kralove
ZIP/Postal Code
505 05
Country
Czech Republic
Facility Name
Novartis Investigative Site
City
Praha 10
ZIP/Postal Code
100 34
Country
Czech Republic
Facility Name
Novartis Investigative Site
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
Facility Name
Novartis Investigative Site
City
Paris cedex 10
ZIP/Postal Code
75010
Country
France
Facility Name
Novartis Investigative Site
City
Paris, Cedex 12
ZIP/Postal Code
F-75571
Country
France
Facility Name
Novartis Investigative Site
City
Bochum
ZIP/Postal Code
44892
Country
Germany
Facility Name
Novartis Investigative Site
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Novartis Investigative Site
City
Duesseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Novartis Investigative Site
City
Freiburg i. Br
ZIP/Postal Code
79106
Country
Germany
Facility Name
Novartis Investigative Site
City
Leipzig
ZIP/Postal Code
04103
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
Regensburg
ZIP/Postal Code
93042
Country
Germany
Facility Name
Novartis Investigative Site
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Novartis Investigative Site
City
Heraklion Crete
State/Province
GR
ZIP/Postal Code
711 10
Country
Greece
Facility Name
Novartis Investigative Site
City
Patras
ZIP/Postal Code
265 00
Country
Greece
Facility Name
Novartis Investigative Site
City
Thessaloniki
ZIP/Postal Code
GR 56429
Country
Greece
Facility Name
Novartis Investigative Site
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Novartis Investigative Site
City
Budapest
ZIP/Postal Code
1133
Country
Hungary
Facility Name
Novartis Investigative Site
City
Debrecen
ZIP/Postal Code
4012
Country
Hungary
Facility Name
Novartis Investigative Site
City
Debrecen
ZIP/Postal Code
4043
Country
Hungary
Facility Name
Novartis Investigative Site
City
Szeged
ZIP/Postal Code
H-6720
Country
Hungary
Facility Name
Novartis Investigative Site
City
Bari
State/Province
BA
ZIP/Postal Code
70124
Country
Italy
Facility Name
Novartis Investigative Site
City
Catania
State/Province
CT
ZIP/Postal Code
95123
Country
Italy
Facility Name
Novartis Investigative Site
City
Milano
State/Province
MI
ZIP/Postal Code
20132
Country
Italy
Facility Name
Novartis Investigative Site
City
Roma
State/Province
RM
ZIP/Postal Code
00198
Country
Italy
Facility Name
Novartis Investigative Site
City
Udine
State/Province
UD
ZIP/Postal Code
33100
Country
Italy
Facility Name
Novartis Investigative Site
City
Varese
State/Province
VA
ZIP/Postal Code
21100
Country
Italy
Facility Name
Novartis Investigative Site
City
Seoul
State/Province
Korea
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
State/Province
Korea
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Busan
ZIP/Postal Code
602-739
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
150-034
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Riga
ZIP/Postal Code
1002
Country
Latvia
Facility Name
Novartis Investigative Site
City
Kaunas
State/Province
LTU
ZIP/Postal Code
50009
Country
Lithuania
Facility Name
Novartis Investigative Site
City
Vilnius
ZIP/Postal Code
LT-08661
Country
Lithuania
Facility Name
Novartis Investigative Site
City
San Isidro
State/Province
Lima
ZIP/Postal Code
27
Country
Peru
Facility Name
Novartis Investigative Site
City
Katowice
ZIP/Postal Code
40-594
Country
Poland
Facility Name
Novartis Investigative Site
City
Wroclaw
ZIP/Postal Code
50-556
Country
Poland
Facility Name
Novartis Investigative Site
City
Coimbra
ZIP/Postal Code
3000-354
Country
Portugal
Facility Name
Novartis Investigative Site
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
Novartis Investigative Site
City
Kazan
ZIP/Postal Code
420012
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Moscow
ZIP/Postal Code
119021
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Moscow
ZIP/Postal Code
127486
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Singapore
ZIP/Postal Code
168751
Country
Singapore
Facility Name
Novartis Investigative Site
City
Banska Bystrica
ZIP/Postal Code
97517
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Trencin
ZIP/Postal Code
91171
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Malaga
State/Province
Andalucia
ZIP/Postal Code
29010
Country
Spain
Facility Name
Novartis Investigative Site
City
Valladolid
State/Province
Castilla y Leon
ZIP/Postal Code
47011
Country
Spain
Facility Name
Novartis Investigative Site
City
Sant Cugat
State/Province
Catalunya
ZIP/Postal Code
08190
Country
Spain
Facility Name
Novartis Investigative Site
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Novartis Investigative Site
City
Binningen
ZIP/Postal Code
4102
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
Istanbul
ZIP/Postal Code
34420
Country
Turkey
Facility Name
Novartis Investigative Site
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

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

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