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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01972789




Registration number
NCT01972789
Ethics application status
Date submitted
24/10/2013
Date registered
30/10/2013

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)
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)
Secondary ID [1] 0 0
CRFB002AAU15
Universal Trial Number (UTN)
Trial acronym
FLUID
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Subfoveal Choroidal Neovascularization CNV Secondary to Wet Age-related Macular Degeneration AMD 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

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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean Change in Best-corrected Visual Acuity (BCVA) From Baseline to 24 Months.
Timepoint [1] 0 0
Baseline to month 24
Secondary outcome [1] 0 0
Mean Change in BCVA From Baseline to Month 12.
Timepoint [1] 0 0
Baseline to month 12
Secondary outcome [2] 0 0
Mean Change in Central Retinal Thickness (CRT) From Baseline to Month 12 and 24.
Timepoint [2] 0 0
Baseline to month 12 and month 24
Secondary outcome [3] 0 0
Mean Number of Injections From Baseline to Month 12 and 24
Timepoint [3] 0 0
Baseline to month 12 to month 24.
Secondary outcome [4] 0 0
Mean Change in Area of New and Existing Geographic Atrophy From Baseline to Month 12 and 24.
Timepoint [4] 0 0
Baseline to months 12 and 24.
Secondary outcome [5] 0 0
Proportion of Patients Showing Newly Developed Geographic Atrophy (GA) at Months 12 and 24
Timepoint [5] 0 0
Months 12 and 24
Secondary outcome [6] 0 0
Proportion of Patients Showing no IRF and SRF at Months 2, 12 and 24.
Timepoint [6] 0 0
Months 2, 12 and 24.
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.
Timepoint [7] 0 0
Baseline to months 12 and 24.
Secondary outcome [8] 0 0
Proportion of Patients Showing Less Than 15 Letters ETDRS Loss From Baseline to Month 12 and 24.
Timepoint [8] 0 0
Baseline to months 12 and 24
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.
Timepoint [9] 0 0
Baseline or following consent
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
Timepoint [10] 0 0
Month 12 and 24
Secondary outcome [11] 0 0
The Number of Times a Participant Needs to Return to Monthly Treatments During the 24 Months.
Timepoint [11] 0 0
Month 24

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

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
Intervention assignment
Parallel
Other design features
Phase
Phase 4
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
31/10/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/02/2017
Sample size
Target
Accrual to date
Final
349
Recruitment in Australia
Recruitment state(s)
NSW,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Novartis Investigative Site - Albury
Recruitment hospital [2] 0 0
Novartis Investigative Site - Chatswood
Recruitment hospital [3] 0 0
Novartis Investigative Site - Eastwood
Recruitment hospital [4] 0 0
Novartis Investigative Site - Hurtsville
Recruitment hospital [5] 0 0
Novartis Investigative Site - Liverpool
Recruitment hospital [6] 0 0
Novartis Investigative Site - North Ryde
Recruitment hospital [7] 0 0
Novartis Investigative Site - Parramatta
Recruitment hospital [8] 0 0
Novartis Investigative Site - Strathfield
Recruitment hospital [9] 0 0
Novartis Investigative Site - Sydney
Recruitment hospital [10] 0 0
Novartis Investigative Site - Westmead
Recruitment hospital [11] 0 0
Novartis Investigative Site - Adelaide
Recruitment hospital [12] 0 0
Novartis Investigative Site - Hobart
Recruitment hospital [13] 0 0
Novartis Investigative Site - South Launceston
Recruitment hospital [14] 0 0
Novartis Investigative Site - Melbourne
Recruitment hospital [15] 0 0
Novartis Investigative Site - Nedlands
Recruitment postcode(s) [1] 0 0
2640 - Albury
Recruitment postcode(s) [2] 0 0
2067 - Chatswood
Recruitment postcode(s) [3] 0 0
2122 - Eastwood
Recruitment postcode(s) [4] 0 0
2220 - Hurtsville
Recruitment postcode(s) [5] 0 0
2170 - Liverpool
Recruitment postcode(s) [6] 0 0
2109 - North Ryde
Recruitment postcode(s) [7] 0 0
2150 - Parramatta
Recruitment postcode(s) [8] 0 0
2135 - Strathfield
Recruitment postcode(s) [9] 0 0
2000 - Sydney
Recruitment postcode(s) [10] 0 0
2145 - Westmead
Recruitment postcode(s) [11] 0 0
5000 - Adelaide
Recruitment postcode(s) [12] 0 0
7000 - Hobart
Recruitment postcode(s) [13] 0 0
7249 - South Launceston
Recruitment postcode(s) [14] 0 0
3000 - Melbourne
Recruitment postcode(s) [15] 0 0
3002 - Melbourne
Recruitment postcode(s) [16] 0 0
6009 - Nedlands

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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01972789