Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
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
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01972789
Registration number
NCT01972789
Ethics application status
Date submitted
24/10/2013
Date registered
30/10/2013
Date last updated
23/10/2019
Titles & IDs
Public title
Comparison of Treatment Regimens Using Ranibizumab: Intensive (Resolution of Intra- and Sub-retinal Fluid) vs Relaxed (Resolution of Intra-retinal Fluid and/or Sub-retinal Fluid >200µm at the Foveal Centre)
Query!
Scientific title
A Phase IV, Randomised, Single Masked Study Investigating the Efficacy and Safety of Ranibizumab "Inject and Extend" Using an Intensive Retinal Fluid Retreatment Regimen Compared to a Relaxed Retinal Fluid Retreatment Regimen in Patients With Wet Age-related Macular Degeneration (AMD)
Query!
Secondary ID [1]
0
0
CRFB002AAU15
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
FLUID
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Subfoveal Choroidal Neovascularization CNV Secondary to Wet Age-related Macular Degeneration AMD
0
0
Query!
Condition category
Condition code
Eye
0
0
0
0
Query!
Diseases / disorders of the eye
Query!
Cardiovascular
0
0
0
0
Query!
Other cardiovascular diseases
Query!
Blood
0
0
0
0
Query!
Haematological diseases
Query!
Blood
0
0
0
0
Query!
Other blood disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Ranibizumab
Experimental: Intensive retinal fluid regimen - Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of =5 letters, new retinal haemorrhage, presence of any IRF or SRF on OCT.
Experimental: Relaxed retinal fluid regimen - Ranibizumab 0.5mg is given monthly for the first 3 months followed by an individualised treatment regimen as determined by disease activity defined by a loss of =5 letters, new retinal haemorrhage, presence of IRF or SRF >200 um on OCT.
Treatment: Drugs: Ranibizumab
Ranibizumab solution for injection is commercially supplied in two presentations: as a pre-filled syringe (containing 1.65 mg of ranibizumab in 0.165 mL solution) and as a vial (containing 2.3 mg of ranibizumab in 0.23 mL solution) corresponding to a recommended dose of 0.5 mg (0.05 mL) given as a single intravitreal injection. It will be prescribed and administered by the investigator or designee
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Mean Change in Best-corrected Visual Acuity (BCVA) From Baseline to 24 Months.
Query!
Assessment method [1]
0
0
Best-corrected visual acuity (BCVA) with refraction will be taken using a logMAR chart at a distance of 3 metres in the study eye at baseline and month 24.
Query!
Timepoint [1]
0
0
Baseline to month 24
Query!
Secondary outcome [1]
0
0
Mean Change in BCVA From Baseline to Month 12.
Query!
Assessment method [1]
0
0
Best-corrected visual acuity (BCVA) with refraction will be taken using a logMAR chart at a distance of 3 metres in the study eye at baseline and month 12.
Query!
Timepoint [1]
0
0
Baseline to month 12
Query!
Secondary outcome [2]
0
0
Mean Change in Central Retinal Thickness (CRT) From Baseline to Month 12 and 24.
Query!
Assessment method [2]
0
0
Central retinal thickness will be measured by Optical Coherence Tomography (OCT) at every visit.
Query!
Timepoint [2]
0
0
Baseline to month 12 and month 24
Query!
Secondary outcome [3]
0
0
Mean Number of Injections From Baseline to Month 12 and 24
Query!
Assessment method [3]
0
0
The number of injections will be determined by the individual patient response to ranibizumab therapy and potential for extension between injections based on specific criteria: loss of visual acuity, new retinal haemorrhage, and presence of IRF or SRF on OCT.
Query!
Timepoint [3]
0
0
Baseline to month 12 to month 24.
Query!
Secondary outcome [4]
0
0
Mean Change in Area of New and Existing Geographic Atrophy From Baseline to Month 12 and 24.
Query!
Assessment method [4]
0
0
Autofluorescence will be measured by multimodal imaging to assess the presence and development of geographic atrophy in the study at baseline, and month 12 and 24.
Query!
Timepoint [4]
0
0
Baseline to months 12 and 24.
Query!
Secondary outcome [5]
0
0
Proportion of Patients Showing Newly Developed Geographic Atrophy (GA) at Months 12 and 24
Query!
Assessment method [5]
0
0
A multimodal imaging approach will be used to assess the presence of new geographic atrophy (defined as incorporating both geographic atrophy and atrophy associated with the CNV) in the study eye at baseline, and month 12 and 24. Image modalities will include fundus autofluorescence (AF) imaging, infrared imaging, OCT and colour fundus (CF) photographs. Atrophy will be diagnosed if FA and one other modality confirm the presence of macular atrophy
Query!
Timepoint [5]
0
0
Months 12 and 24
Query!
Secondary outcome [6]
0
0
Proportion of Patients Showing no IRF and SRF at Months 2, 12 and 24.
Query!
Assessment method [6]
0
0
Assessed by Optical Coherence Tomography (OCT) and confirmed by a central reading centre.
Query!
Timepoint [6]
0
0
Months 2, 12 and 24.
Query!
Secondary outcome [7]
0
0
Proportion of Patients Showing Greater Than or Equal to 15 Letters Early Treatment Diabetic Retinopathy (ETDRS) Gain From Baseline to Month 12 and 24.
Query!
Assessment method [7]
0
0
Best-corrected visual acuity (BCVA) with refraction will be taken using a logMAR chart at a distance of 3 metres in the study eye at baseline and months 2, 12 and 24.
Query!
Timepoint [7]
0
0
Baseline to months 12 and 24.
Query!
Secondary outcome [8]
0
0
Proportion of Patients Showing Less Than 15 Letters ETDRS Loss From Baseline to Month 12 and 24.
Query!
Assessment method [8]
0
0
Best-corrected visual acuity with refraction will be taken using a logMAR chart at a distance of 3 metres in the study eye at baseline and months 2, 12 and 24.
Query!
Timepoint [8]
0
0
Baseline to months 12 and 24
Query!
Secondary outcome [9]
0
0
Number of Participants With the Genotypes Associated With Age-Related Macular Degeneration (AMD) and Response to Treatment at Baseline; Correlation With Visual Acuity (VA) Outcome and Ability to Dry the Retina.
Query!
Assessment method [9]
0
0
DNA will be extracted from saliva and genotyping performed on the significantly associated single nucleotide polymorphisms (SNPs) identified by the AMD Gene Consortium (Nature Genetics, March 2013). Genotypes will be derived through the use of a Sequenom Iplex protocol. No correlation analyses were performed.
Query!
Timepoint [9]
0
0
Baseline or following consent
Query!
Secondary outcome [10]
0
0
Proportion of Patients With Both SRF (Sub-retinal Fluid) and IRF (Intra-retinal Fluid) Who Despite Monthly Treatment do Not Resolve Their SRF
Query!
Assessment method [10]
0
0
Assessed by Optical Coherence Tomography (OCT) and confirmed by a central reading centre.
Query!
Timepoint [10]
0
0
Month 12 and 24
Query!
Secondary outcome [11]
0
0
The Number of Times a Participant Needs to Return to Monthly Treatments During the 24 Months.
Query!
Assessment method [11]
0
0
Treatment requirements will be determined by the individual patient disease activity as measured by OCT, BCVA, colour fundus photography and fluorescein angiography (FA). Analysis was not performed.
Query!
Timepoint [11]
0
0
Month 24
Query!
Eligibility
Key inclusion criteria
1. Diagnosis of subfoveal CNV secondary to wet AMD without restriction of lesion size,
with visual impairment being exclusively due to an active wet AMD lesion. Active
lesions will be characterised by any of the following: abnormal retinal thickness,
with evidence of intraretinal, subretinal or sub-pigment epithelial fluid
accumulation, confirmed by OCT; presence of intraretinal or subretinal haemorrhage;
new leakage shown on a FA; CNV enlargement on FA unless solely due to dry, fibrotic
staining; visual acuity deterioration considered likely to represent CNV.
2. BCVA score at both Screening and Baseline must be 23 letters or more as measured by
the Early Treatment Diabetic Retinopathy Study (ETDRS) logMAR charts (a Snellen visual
acuity or equivalent of 20/320 or more may be used as an alternative at Screening).
Query!
Minimum age
50
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
1. Any active periocular or ocular infection or inflammation (e.g., blepharitis,
conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) at the time of
Screening or Baseline.
2. Uncontrolled glaucoma (intraocular pressure [IOP] =30 mm Hg on medication) at the time
of Screening or Baseline.
3. Neovascularisation of the iris or neovascular glaucoma at the time of Screening or
Baseline.
4. Visually significant cataract, aphakia, severe vitreous haemorrhage, rhegmatogenous
retinal detachment, proliferative diabetic retinopathy or CNV of any cause other than
wet AMD at the time of screening and baseline.
5. Structural damage within 0.5 disc diameter of the centre of the macula (e.g.,
vitreomacular traction, epiretinal membrane, scar, laser burn, foveal atrophy) at the
time of screening that in the investigator's opinion could preclude visual function
improvement with treatment.
6. Treatment with any anti-angiogenic drugs (including any anti-VEGF agents) prior to
Baseline in study eye (allowed in fellow eye).
7. Any intraocular procedure (including Ytrium-Aluminium- Garnet capsulotomy) within 2
months prior to Baseline or anticipated within the next 6 months following Baseline in
th study eye (allowed in fellow eye).
Other protocol-defined inclusion/exclusion criteria may apply.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 4
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
31/10/2013
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
28/02/2017
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
349
Query!
Recruitment in Australia
Recruitment state(s)
NSW,SA,TAS,VIC,WA
Query!
Recruitment hospital [1]
0
0
Novartis Investigative Site - Albury
Query!
Recruitment hospital [2]
0
0
Novartis Investigative Site - Chatswood
Query!
Recruitment hospital [3]
0
0
Novartis Investigative Site - Eastwood
Query!
Recruitment hospital [4]
0
0
Novartis Investigative Site - Hurtsville
Query!
Recruitment hospital [5]
0
0
Novartis Investigative Site - Liverpool
Query!
Recruitment hospital [6]
0
0
Novartis Investigative Site - North Ryde
Query!
Recruitment hospital [7]
0
0
Novartis Investigative Site - Parramatta
Query!
Recruitment hospital [8]
0
0
Novartis Investigative Site - Strathfield
Query!
Recruitment hospital [9]
0
0
Novartis Investigative Site - Sydney
Query!
Recruitment hospital [10]
0
0
Novartis Investigative Site - Westmead
Query!
Recruitment hospital [11]
0
0
Novartis Investigative Site - Adelaide
Query!
Recruitment hospital [12]
0
0
Novartis Investigative Site - Hobart
Query!
Recruitment hospital [13]
0
0
Novartis Investigative Site - South Launceston
Query!
Recruitment hospital [14]
0
0
Novartis Investigative Site - Melbourne
Query!
Recruitment hospital [15]
0
0
Novartis Investigative Site - Nedlands
Query!
Recruitment postcode(s) [1]
0
0
2640 - Albury
Query!
Recruitment postcode(s) [2]
0
0
2067 - Chatswood
Query!
Recruitment postcode(s) [3]
0
0
2122 - Eastwood
Query!
Recruitment postcode(s) [4]
0
0
2220 - Hurtsville
Query!
Recruitment postcode(s) [5]
0
0
2170 - Liverpool
Query!
Recruitment postcode(s) [6]
0
0
2109 - North Ryde
Query!
Recruitment postcode(s) [7]
0
0
2150 - Parramatta
Query!
Recruitment postcode(s) [8]
0
0
2135 - Strathfield
Query!
Recruitment postcode(s) [9]
0
0
2000 - Sydney
Query!
Recruitment postcode(s) [10]
0
0
2145 - Westmead
Query!
Recruitment postcode(s) [11]
0
0
5000 - Adelaide
Query!
Recruitment postcode(s) [12]
0
0
7000 - Hobart
Query!
Recruitment postcode(s) [13]
0
0
7249 - South Launceston
Query!
Recruitment postcode(s) [14]
0
0
3000 - Melbourne
Query!
Recruitment postcode(s) [15]
0
0
3002 - Melbourne
Query!
Recruitment postcode(s) [16]
0
0
6009 - Nedlands
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Novartis Pharmaceuticals
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
To evaluate and compare two individualised ranibizumab treatment regimens, differentiated by
the definition of disease activity, which determines the treatment interval until the next
injection. The results will be used to generate recommendations about ranibizumab treatment
when using an 'inject and extend' approach to maximise patient outcomes, while reducing the
need for potentially unnecessary intravitreal injections. This study will also investigate if
genotypic expression influences response to intravitreal injections of ranibizumab between
the two treatment arms.
The study hypothesis is that intravitreal ranibizumab when administered to resolve IRF
(and/or SRF >200 µm at the foveal centre) results in visual acuity benefit that is not
clinically worse than intravitreal ranibizumab when administered to completely resolve both
IRF and SRF in patients with wet AMD
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT01972789
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Novartis Pharmaceuticals
Query!
Address
0
0
Novartis Pharmaceuticals
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01972789
Download to PDF