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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01846299




Registration number
NCT01846299
Ethics application status
Date submitted
30/04/2013
Date registered
3/05/2013
Date last updated
23/05/2016

Titles & IDs
Public title
To Assess the Efficacy and Safety of Intravitreal Ranibizumab in People With Vision Loss Due to Macular Edema
Scientific title
A 12-month, Randomized, Double-masked, Sham-controlled, Multicenter Study to Evaluate the Efficacy and Safety of 0.5mg Ranibizumab Intravtitreal Injections in Patients With Visual Impairment Due to Vascular Endothelial Growth Factor (VEGF)Driven Macular Edema
Secondary ID [1] 0 0
2012-005418-20
Secondary ID [2] 0 0
CRFB002G2302
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Macular Edema (ME) 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

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

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 switched to open-label ranibizumab on an as needed basis.


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.

Treatment: Drugs: Ranibizumab
Ranibizumab 0.5mg/0.5mL was administered intravitreally to the participant.
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

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

Eligibility
Key inclusion criteria
* Diagnosis of active ME secondary to any causes (for adult patients: except diabetic macular edema (DME), age-related macular degeneration (AMD) and retinal vein occlusion (RVO));
* BCVA must be between = 24 and = 83 letters;
* Visual loss should be mainly due to the presence of any eligible types of ME.
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, related directly to the underlying causal disease of ME;
* Active diabetic retinopathy, active ocular/periocular infectious disease or active severe intra-ocular inflammation;
* Any type of advanced, severe or unstable ocular disease or its reatment;
* ME with a high likelihood of spontaneous resolution.

Other protocol-defined inclusion/exclusion criteria may apply.

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
1/10/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2015
Sample size
Target
Accrual to date
Final
181
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 - Westmead
Recruitment hospital [3] 0 0
Novartis Investigative Site - Adelaide
Recruitment hospital [4] 0 0
Novartis Investigative Site - Hobart
Recruitment hospital [5] 0 0
Novartis Investigative Site - South Launceston
Recruitment postcode(s) [1] 0 0
2000 - Sydney
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
7000 - Hobart
Recruitment postcode(s) [5] 0 0
7249 - South Launceston
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Leuven
Country [2] 0 0
Canada
State/province [2] 0 0
Nova Scotia
Country [3] 0 0
Czech Republic
State/province [3] 0 0
Plzen
Country [4] 0 0
Czech Republic
State/province [4] 0 0
Praha 10
Country [5] 0 0
France
State/province [5] 0 0
Bordeaux Cedex
Country [6] 0 0
France
State/province [6] 0 0
Lyon
Country [7] 0 0
France
State/province [7] 0 0
Paris cedex 10
Country [8] 0 0
France
State/province [8] 0 0
Saint-Jean
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
Regensburg
Country [13] 0 0
Hungary
State/province [13] 0 0
Budapest
Country [14] 0 0
Hungary
State/province [14] 0 0
Debrecen
Country [15] 0 0
Hungary
State/province [15] 0 0
Szeged
Country [16] 0 0
Israel
State/province [16] 0 0
Jerusalem
Country [17] 0 0
Israel
State/province [17] 0 0
Kfar-Sava
Country [18] 0 0
Israel
State/province [18] 0 0
Petach Tikva
Country [19] 0 0
Israel
State/province [19] 0 0
Rehovot
Country [20] 0 0
Israel
State/province [20] 0 0
Tel-Aviv
Country [21] 0 0
Italy
State/province [21] 0 0
FI
Country [22] 0 0
Italy
State/province [22] 0 0
GE
Country [23] 0 0
Italy
State/province [23] 0 0
MI
Country [24] 0 0
Italy
State/province [24] 0 0
PI
Country [25] 0 0
Italy
State/province [25] 0 0
RM
Country [26] 0 0
Italy
State/province [26] 0 0
TO
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
Netherlands
State/province [31] 0 0
Amsterdam
Country [32] 0 0
Netherlands
State/province [32] 0 0
Tilburg
Country [33] 0 0
Russian Federation
State/province [33] 0 0
Kazan
Country [34] 0 0
Russian Federation
State/province [34] 0 0
Moscow
Country [35] 0 0
Singapore
State/province [35] 0 0
Singapore
Country [36] 0 0
Slovakia
State/province [36] 0 0
Banska Bystrica
Country [37] 0 0
Slovakia
State/province [37] 0 0
Trencin
Country [38] 0 0
Spain
State/province [38] 0 0
Andalucia
Country [39] 0 0
Spain
State/province [39] 0 0
Barcelona
Country [40] 0 0
Spain
State/province [40] 0 0
Castilla y Leon
Country [41] 0 0
Spain
State/province [41] 0 0
Catalunya
Country [42] 0 0
Switzerland
State/province [42] 0 0
Bern
Country [43] 0 0
Switzerland
State/province [43] 0 0
Binningen
Country [44] 0 0
Switzerland
State/province [44] 0 0
Zuerich
Country [45] 0 0
Turkey
State/province [45] 0 0
Ankara
Country [46] 0 0
Turkey
State/province [46] 0 0
Kocaeli
Country [47] 0 0
United Kingdom
State/province [47] 0 0
Surrey
Country [48] 0 0
United Kingdom
State/province [48] 0 0
Birmingham
Country [49] 0 0
United Kingdom
State/province [49] 0 0
Bristol
Country [50] 0 0
United Kingdom
State/province [50] 0 0
London
Country [51] 0 0
United Kingdom
State/province [51] 0 0
Manchester
Country [52] 0 0
United Kingdom
State/province [52] 0 0
Southampton
Country [53] 0 0
United Kingdom
State/province [53] 0 0
Sunderland

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01846299