Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01840410




Registration number
NCT01840410
Ethics application status
Date submitted
23/04/2013
Date registered
25/04/2013
Date last updated
26/08/2016

Titles & IDs
Public title
Assess the Efficacy/Safety of Intravitreal Ranibizumab in Patients With Vision Loss Due to Choroidal Neovascularization.
Scientific 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.
Secondary ID [1] 0 0
2012-005417-38
Secondary ID [2] 0 0
CRFB002G2301
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Choroidal Neovascularization (CNV) 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Blood 0 0 0 0
Haematological diseases
Blood 0 0 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ranibizumab
Other interventions - Sham control

Experimental: Ranibizumab - 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 Comparator: Sham control - 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.


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

Other interventions: Sham control
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.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Best-corrected Visual Acuity (BCVA) in Study Eye to Month 2
Timepoint [1] 0 0
Baseline, Month 2
Secondary outcome [1] 0 0
Change From Baseline in BCVA in Study Eye up to Month 2
Timepoint [1] 0 0
Baseline, Month 1, Month 2
Secondary outcome [2] 0 0
Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye
Timepoint [2] 0 0
Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Secondary outcome [3] 0 0
Change From Baseline in Central Subfield Volume (CSFV) in Study Eye
Timepoint [3] 0 0
Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Secondary outcome [4] 0 0
Number of Participants With Presence of Intra-retinal Fluid in Study Eye Compared to Baseline
Timepoint [4] 0 0
Baseline, Month 2, Month 6, Month 12
Secondary outcome [5] 0 0
Number of Participants With Presence of Subretinal Fluid in Study Eye Compared to Baseline
Timepoint [5] 0 0
Baseline, Month 2, Month 6, Month 12
Secondary outcome [6] 0 0
Number of Participants With Presence of Active Chorioretinal Leakage
Timepoint [6] 0 0
Baseline, Month 2, Month 6, Month 12
Secondary outcome [7] 0 0
Average Change From Baseline in BCVA
Timepoint [7] 0 0
Baseline (BL), Month 1 through Month 6, Month 1 through Month 12
Secondary outcome [8] 0 0
Number of Participants With = 1, = 5, = 10 and = 15 Letters Gain or Reaching 84 Letters
Timepoint [8] 0 0
Month 2, Month 6, Month 12
Secondary outcome [9] 0 0
Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss
Timepoint [9] 0 0
Month 2, Month 6, Month 12
Secondary outcome [10] 0 0
Number of Participants With Requirement for Rescue Treatment at Month 1
Timepoint [10] 0 0
Month 1
Secondary outcome [11] 0 0
Number of Participants With Ranibizumab Treatments in Study Eye
Timepoint [11] 0 0
Month 12
Secondary outcome [12] 0 0
Number of Participants With Re-treatments
Timepoint [12] 0 0
Month 12
Secondary outcome [13] 0 0
Number of Primary Reasons for Decision to Treat by Investigator
Timepoint [13] 0 0
Month 12

Eligibility
Key inclusion criteria
Key

- 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
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2015
Sample size
Target
Accrual to date
Final
183
Recruitment in Australia
Recruitment state(s)
NSW,SA,TAS
Recruitment hospital [1] 0 0
Novartis Investigative Site - Sydney
Recruitment hospital [2] 0 0
Novartis Investigative Site - Adelaide
Recruitment hospital [3] 0 0
Novartis Investigative Site - South Launceston
Recruitment postcode(s) [1] 0 0
2000 - Sydney
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
7249 - South Launceston
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Quebec
Country [2] 0 0
Czech Republic
State/province [2] 0 0
Hradec Kralove
Country [3] 0 0
Czech Republic
State/province [3] 0 0
Praha 10
Country [4] 0 0
Denmark
State/province [4] 0 0
Glostrup
Country [5] 0 0
France
State/province [5] 0 0
Paris cedex 10
Country [6] 0 0
France
State/province [6] 0 0
Paris, Cedex 12
Country [7] 0 0
Germany
State/province [7] 0 0
Bochum
Country [8] 0 0
Germany
State/province [8] 0 0
Bonn
Country [9] 0 0
Germany
State/province [9] 0 0
Duesseldorf
Country [10] 0 0
Germany
State/province [10] 0 0
Freiburg i. Br
Country [11] 0 0
Germany
State/province [11] 0 0
Leipzig
Country [12] 0 0
Germany
State/province [12] 0 0
Muenster
Country [13] 0 0
Germany
State/province [13] 0 0
Regensburg
Country [14] 0 0
Germany
State/province [14] 0 0
Tübingen
Country [15] 0 0
Greece
State/province [15] 0 0
GR
Country [16] 0 0
Greece
State/province [16] 0 0
Patras
Country [17] 0 0
Greece
State/province [17] 0 0
Thessaloniki
Country [18] 0 0
Hungary
State/province [18] 0 0
Budapest
Country [19] 0 0
Hungary
State/province [19] 0 0
Debrecen
Country [20] 0 0
Hungary
State/province [20] 0 0
Szeged
Country [21] 0 0
Italy
State/province [21] 0 0
BA
Country [22] 0 0
Italy
State/province [22] 0 0
CT
Country [23] 0 0
Italy
State/province [23] 0 0
MI
Country [24] 0 0
Italy
State/province [24] 0 0
RM
Country [25] 0 0
Italy
State/province [25] 0 0
UD
Country [26] 0 0
Italy
State/province [26] 0 0
VA
Country [27] 0 0
Korea, Republic of
State/province [27] 0 0
Korea
Country [28] 0 0
Korea, Republic of
State/province [28] 0 0
Busan
Country [29] 0 0
Korea, Republic of
State/province [29] 0 0
Seoul
Country [30] 0 0
Latvia
State/province [30] 0 0
Riga
Country [31] 0 0
Lithuania
State/province [31] 0 0
LTU
Country [32] 0 0
Lithuania
State/province [32] 0 0
Vilnius
Country [33] 0 0
Peru
State/province [33] 0 0
Lima
Country [34] 0 0
Poland
State/province [34] 0 0
Katowice
Country [35] 0 0
Poland
State/province [35] 0 0
Wroclaw
Country [36] 0 0
Portugal
State/province [36] 0 0
Coimbra
Country [37] 0 0
Portugal
State/province [37] 0 0
Porto
Country [38] 0 0
Russian Federation
State/province [38] 0 0
Kazan
Country [39] 0 0
Russian Federation
State/province [39] 0 0
Moscow
Country [40] 0 0
Singapore
State/province [40] 0 0
Singapore
Country [41] 0 0
Slovakia
State/province [41] 0 0
Banska Bystrica
Country [42] 0 0
Slovakia
State/province [42] 0 0
Trencin
Country [43] 0 0
Spain
State/province [43] 0 0
Andalucia
Country [44] 0 0
Spain
State/province [44] 0 0
Castilla y Leon
Country [45] 0 0
Spain
State/province [45] 0 0
Catalunya
Country [46] 0 0
Switzerland
State/province [46] 0 0
Bern
Country [47] 0 0
Switzerland
State/province [47] 0 0
Binningen
Country [48] 0 0
Switzerland
State/province [48] 0 0
Lausanne
Country [49] 0 0
Turkey
State/province [49] 0 0
Ankara
Country [50] 0 0
Turkey
State/province [50] 0 0
Istanbul
Country [51] 0 0
Turkey
State/province [51] 0 0
Kocaeli

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT01840410
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01840410