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CompletedNCT01972789FLUIDUpdated Oct 23, 2019Results posted

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)

A Phase 4 interventional study of Ranibizumab in Subfoveal Choroidal Neovascularization CNV Secondary to Wet Age-related Macular Degeneration AMD, sponsored by Novartis Pharmaceuticals. Completed at 16 sites in Australia. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2019-10-23.

Sponsored by Novartis Pharmaceuticals · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
349
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Subfoveal Choroidal Neovascularization CNV Secondary to Wet Age-related Macular Degeneration AMD

Keywords

  • Subfoveal choroidal neovascularization (CNV)
  • wet age-related macular degeneration(AMD)
  • inject and extend
  • retinal fluid
03

In context

Macular Degeneration

1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.

This study's enrollment of 349 is above the median of 51 across 985 interventional studies indexed under Macular Degeneration.

Browse Macular Degeneration studies →

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.

Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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).

Exclusion criteria

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.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
349 participants (actual)

Study arms

  • 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.

    Drug: Ranibizumab

  • 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.

    Drug: Ranibizumab

Interventions

  • DrugRanibizumab

    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

    Also known as: LUCENTIS

06

What researchers measure

Primary outcomes

  1. Mean Change in Best-corrected Visual Acuity (BCVA) From Baseline to 24 Months.

    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.

    Time frame: Baseline to month 24

Secondary outcomes

  1. Mean Change in BCVA From Baseline to Month 12.

    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.

    Time frame: Baseline to month 12

  2. Mean Change in Central Retinal Thickness (CRT) From Baseline to Month 12 and 24.

    Central retinal thickness will be measured by Optical Coherence Tomography (OCT) at every visit.

    Time frame: Baseline to month 12 and month 24

  3. Mean Number of Injections From Baseline to Month 12 and 24

    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.

    Time frame: Baseline to month 12 to month 24.

  4. Mean Change in Area of New and Existing Geographic Atrophy From Baseline to Month 12 and 24.

    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.

    Time frame: Baseline to months 12 and 24.

  5. Proportion of Patients Showing Newly Developed Geographic Atrophy (GA) at Months 12 and 24

    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

    Time frame: Months 12 and 24

  6. Proportion of Patients Showing no IRF and SRF at Months 2, 12 and 24.

    Assessed by Optical Coherence Tomography (OCT) and confirmed by a central reading centre.

    Time frame: Months 2, 12 and 24.

  7. Proportion of Patients Showing Greater Than or Equal to 15 Letters Early Treatment Diabetic Retinopathy (ETDRS) Gain From Baseline to Month 12 and 24.

    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.

    Time frame: Baseline to months 12 and 24.

  8. Proportion of Patients Showing Less Than 15 Letters ETDRS Loss From Baseline to Month 12 and 24.

    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.

    Time frame: Baseline to months 12 and 24

  9. 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.

    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.

    Time frame: Baseline or following consent

  10. Proportion of Patients With Both SRF (Sub-retinal Fluid) and IRF (Intra-retinal Fluid) Who Despite Monthly Treatment do Not Resolve Their SRF

    Assessed by Optical Coherence Tomography (OCT) and confirmed by a central reading centre.

    Time frame: Month 12 and 24

  11. The Number of Times a Participant Needs to Return to Monthly Treatments During the 24 Months.

    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.

    Time frame: Month 24

07

Results

Posted Oct 23, 2019

Participant flow

a total of 349 subjects were randomized to the study (intensive arm, 174; relaxed arm, 175). relaxed 173).

Participant flow — Overall Study
MilestoneIntensive Retinal Fluid RegimenRelaxed Retinal Fluid Regimen
Started174175
Completed134145
Not completed4030
Withdrew: Adverse event114
Withdrew: Subject withdrew consent1412
Withdrew: Lost to follow-up47
Withdrew: Death75
Withdrew: Protocol deviation10
Withdrew: Physician decision32

Outcome measures

PrimaryMean Change in Best-corrected Visual Acuity (BCVA) From Baseline to 24 Months.

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.

Time frame:
Baseline to month 24
Reported as:
Mean · Letters
Mean Change in Best-corrected Visual Acuity (BCVA) From Baseline to 24 Months.
LettersIntensive Retinal Fluid RegimenRelaxed Retinal Fluid Regimen
Mean Change in Best-corrected Visual Acuity (BCVA) From Baseline to 24 Months.3.2 ± 16.512.5 ± 16.56
Statistical analysis
  • Intensive Retinal Fluid Regimen vs Relaxed Retinal Fluid Regimen · Mixed Models Analysis · p = 0.787 · Odds ratio (or): 0.40 · 95% CI -2.51 to 3.32
SecondaryMean Change in BCVA From Baseline to Month 12.

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.

Time frame:
Baseline to month 12
Reported as:
Mean · Letters
Mean Change in BCVA From Baseline to Month 12.
LettersIntensive Retinal Fluid RegimenRelaxed Retinal Fluid Regimen
Mean Change in BCVA From Baseline to Month 12.4.6 ± 14.693.9 ± 12.73
Statistical analysis
  • Intensive Retinal Fluid Regimen vs Relaxed Retinal Fluid Regimen · Mixed Models Analysis · p = 0.833 · Odds ratio (or): -0.31 · 95% CI -3.20 to 2.58
SecondaryMean Change in Central Retinal Thickness (CRT) From Baseline to Month 12 and 24.

Central retinal thickness will be measured by Optical Coherence Tomography (OCT) at every visit.

Time frame:
Baseline to month 12 and month 24
Reported as:
Mean · μm
Mean Change in Central Retinal Thickness (CRT) From Baseline to Month 12 and 24.
μmIntensive Retinal Fluid RegimenRelaxed Retinal Fluid Regimen
Month 12-147.1 ± 168.33-125.6 ± 133.08
Month 24-158.9 ± 170.44-126.9 ± 140.01
Statistical analysis
  • Intensive Retinal Fluid Regimen vs Relaxed Retinal Fluid Regimen · Mixed Models Analysis · p = 0.054 · Odds ratio (or): -21.39 · 95% CI -43.17 to 0.39
SecondaryMean Number of Injections From Baseline to Month 12 and 24

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.

Time frame:
Baseline to month 12 to month 24.
Reported as:
Mean · Injections
Mean Number of Injections From Baseline to Month 12 and 24
InjectionsIntensive Retinal Fluid RegimenRelaxed Retinal Fluid Regimen
Month 129.5 ± 2.608.9 ± 2.25
Month 2417 ± 6.4815.8 ± 5.91
Statistical analysis
  • Intensive Retinal Fluid Regimen vs Relaxed Retinal Fluid Regimen · Mixed Model · p = 0.001 · Negative binomial regression: 1.11 · 95% CI 1.04 to 1.18
SecondaryMean Change in Area of New and Existing Geographic Atrophy From Baseline to Month 12 and 24.

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.

Time frame:
Baseline to months 12 and 24.
Reported as:
Mean · mm^2
Mean Change in Area of New and Existing Geographic Atrophy From Baseline to Month 12 and 24.
mm^2Intensive Retinal Fluid RegimenRelaxed Retinal Fluid Regimen
Month 120.8 ± 2.130.7 ± 1.80
Month 241.5 ± 3.181.2 ± 2.62
Statistical analysis
  • Intensive Retinal Fluid Regimen vs Relaxed Retinal Fluid Regimen · Mixed Models Analysis · p = 0.338 · Odds ratio (or): 0.26 · 95% CI -0.28 to 0.80
SecondaryProportion of Patients Showing Newly Developed Geographic Atrophy (GA) at Months 12 and 24

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

Time frame:
Months 12 and 24
Reported as:
Number · Participants
Proportion of Patients Showing Newly Developed Geographic Atrophy (GA) at Months 12 and 24
ParticipantsIntensive Retinal Fluid RegimenRelaxed Retinal Fluid Regimen
Month 12, GA present2518
Month 12, GA absent103110
Month 24, GA present3229
Month 24, GA absent8094
Statistical analysis
  • Intensive Retinal Fluid Regimen vs Relaxed Retinal Fluid Regimen · Regression, Logistic · p = 0.284 · Odds ratio (or): 1.44 · 95% CI 0.74 to 2.80
  • Intensive Retinal Fluid Regimen vs Relaxed Retinal Fluid Regimen · Regression, Logistic · p = 0.407 · Odds ratio (or): 1.29 · 95% CI 0.71 to 2.33
SecondaryProportion of Patients Showing no IRF and SRF at Months 2, 12 and 24.

Assessed by Optical Coherence Tomography (OCT) and confirmed by a central reading centre.

Time frame:
Months 2, 12 and 24.
Reported as:
Number · Participants
Proportion of Patients Showing no IRF and SRF at Months 2, 12 and 24.
ParticipantsIntensive Retinal Fluid RegimenRelaxed Retinal Fluid Regimen
Month 210693
month 128772
Month 246456
Statistical analysis
  • Intensive Retinal Fluid Regimen vs Relaxed Retinal Fluid Regimen · Regression, Logistic · p = 0.217 · Odds ratio (or): 0.35 · 95% CI 0.12 to 1.04
SecondaryProportion of Patients Showing Greater Than or Equal to 15 Letters Early Treatment Diabetic Retinopathy (ETDRS) Gain From Baseline to Month 12 and 24.

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.

Time frame:
Baseline to months 12 and 24.
Reported as:
Number · Participants
Proportion of Patients Showing Greater Than or Equal to 15 Letters Early Treatment Diabetic Retinopathy (ETDRS) Gain From Baseline to Month 12 and 24.
ParticipantsIntensive Retinal Fluid RegimenRelaxed Retinal Fluid Regimen
Month 122924
Month 242524
Statistical analysis
  • Intensive Retinal Fluid Regimen vs Relaxed Retinal Fluid Regimen · Regression, Logistic · p = 0.615 · Odds ratio (or): 0.84 · 95% CI 0.42 to 1.66
SecondaryProportion of Patients Showing Less Than 15 Letters ETDRS Loss From Baseline to Month 12 and 24.

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.

Time frame:
Baseline to months 12 and 24
Reported as:
Number · Participants
Proportion of Patients Showing Less Than 15 Letters ETDRS Loss From Baseline to Month 12 and 24.
ParticipantsIntensive Retinal Fluid RegimenRelaxed Retinal Fluid Regimen
Month 12142141
Month 24129132
Statistical analysis
  • Intensive Retinal Fluid Regimen vs Relaxed Retinal Fluid Regimen · Regression, Logistic · p = 0.819 · Odds ratio (or): 1.08 · 95% CI 0.54 to 2.18
SecondaryNumber 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.

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.

Time frame:
Baseline or following consent
Reported as:
Number · Participants
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.
ParticipantsIntensive Retinal Fluid RegimenRelaxed Retinal Fluid Regimen
RS10490924 GG4447
RS10490924 GT5657
RS10490924 TT2423
RS1061170 CC3543
RS1061170 CT6161
RS1061170 TT2921
RS10737680 AA6882
RS10737680 AC4837
RS10737680 CC98
RS11200638 AA2123
RS11200638 AG5858
RS11200638 GG4646
RS121913059 CC124127
RS121913059 CT10
RS13278062 GG2917
RS13278062 GT6075
RS13278062 TT3635
RS141853578 CC125125
RS147859257 GT21
RS147859257 TT123126
RS1864163 AA97
RS1864163 AG2946
RS1864163 GG8573
RS2230199 CC8167
RS2230199 CG3752
RS2230199 GG68
RS3130783 AA7791
RS3130783 AG4432
RS3130783 GG44
RS334353 GG611
RS334353 GT4145
RS334353 TT7871
RS3812111 AA3116
RS3812111 AT5752
RS3812111 TT3654
RS429608 AA21
RS429608 AG1919
RS429608 GG103103
RS4420638 AA8996
RS4420638 AG3531
RS4698775 GG118
RS4698775 GT5371
RS4698775 TT6047
RS5749482 CC41
RS5749482 CG2626
RS5749482 GG95100
RS6795735 CC4337
RS6795735 CT5363
RS6795735 TT2827
RS8017304 AA5765
RS8017304 AG5351
RS8017304 GG1511
RS8135665 CC6879
RS8135665 CT5041
RS8135665 TT67
RS920915 CC3233
RS920915 CG6460
RS920915 GG2834
RS943080 CC2735
RS943080 CT5764
RS943080 TT4028
RS9542236 CC2626
RS9542236 CT6163
RS9542236 TT3838
SecondaryProportion of Patients With Both SRF (Sub-retinal Fluid) and IRF (Intra-retinal Fluid) Who Despite Monthly Treatment do Not Resolve Their SRF

Assessed by Optical Coherence Tomography (OCT) and confirmed by a central reading centre.

Time frame:
Month 12 and 24
Reported as:
Number · Participants
Proportion of Patients With Both SRF (Sub-retinal Fluid) and IRF (Intra-retinal Fluid) Who Despite Monthly Treatment do Not Resolve Their SRF
ParticipantsIntensive Retinal Fluid RegimenRelaxed Retinal Fluid Regimen
Month 1232
Month 2412
Statistical analysis
  • Intensive Retinal Fluid Regimen vs Relaxed Retinal Fluid Regimen · Regression, Logistic · p = 0.565 · Odds ratio (or): 4.32 · 95% CI 0.03 to 630.5
SecondaryThe Number of Times a Participant Needs to Return to Monthly Treatments During the 24 Months.

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.

Time frame:
Month 24
Reported as:
Mean · Visits
The Number of Times a Participant Needs to Return to Monthly Treatments During the 24 Months.
VisitsIntensive Retinal Fluid RegimenRelaxed Retinal Fluid Regimen
The Number of Times a Participant Needs to Return to Monthly Treatments During the 24 Months.10.6 ± 8.347.6 ± 8.09
Statistical analysis
  • Intensive Retinal Fluid Regimen vs Relaxed Retinal Fluid Regimen · Regression, Logistic · p = 0.034 · Odds ratio (or): 1.39 · 95% CI 1.03 to 1.90

Adverse events

Collected over Up to 24 month. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Intensive7/173 (4%)58/173 (33.5%)109/173 (63%)
Relaxed5/174 (2.9%)58/174 (33.3%)114/174 (65.5%)
Most frequent serious events
Showing 10 of 278
Most frequent serious events
EventIntensiveRelaxed
PneumoniaInfections and infestations10/1735/174
Pneumonia(Non-ocular)Infections and infestations10/1735/174
Atrial fibrillationCardiac disorders2/1737/174
Atrial fibrillation(Non-ocular)Cardiac disorders2/1737/174
FallInjury, poisoning and procedural complications4/1732/174
Transient ischaemic attackNervous system disorders4/1732/174
Fall(Non-ocular)Injury, poisoning and procedural complications4/1732/174
Transient ischaemic attack(Non-ocular)Nervous system disorders4/1732/174
Cerebrovascular accidentNervous system disorders3/1734/174
Cerebrovascular accident(Non-ocular)Nervous system disorders3/1734/174
Most frequent other events
Showing 10 of 44
Most frequent other events
EventIntensiveRelaxed
NasopharyngitisInfections and infestations23/17329/174
Nasopharyngitis(Non-ocular)Infections and infestations23/17329/174
Eye painEye disorders28/17324/174
InfluenzaInfections and infestations26/17316/174
Influenza(Non-ocular)Infections and infestations26/17316/174
Vitreous floatersEye disorders21/17311/174
FallInjury, poisoning and procedural complications21/17315/174
Fall(Non-ocular)Injury, poisoning and procedural complications21/17315/174
Age-related macular degenerationEye disorders18/17317/174
Lacrimation increasedEye disorders17/1738/174

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Intensive Retinal Fluid RegimenRelaxed Retinal Fluid RegimenTotal
Mean79.3 ± 8.1278.8 ± 8.1779 ± 8.12
Sex: Female, Male
Sex: Female, Male(Participants)Intensive Retinal Fluid RegimenRelaxed Retinal Fluid RegimenTotal
Female10089189
Male7486160
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Intensive Retinal Fluid RegimenRelaxed Retinal Fluid RegimenTotal
American Indian or Alaska Native000
Asian9312
Native Hawaiian or Other Pacific Islander000
Black or African American000
White163171334
More than one race000
Unknown or Not Reported213
08

Study locations

16 sites
  • Novartis Investigative Site
    Albury, New South Wales 2640, Australia
  • Novartis Investigative Site
    Chatswood, New South Wales 2067, Australia
  • Novartis Investigative Site
    Eastwood, New South Wales 2122, Australia
  • Novartis Investigative Site
    Hurtsville, New South Wales 2220, Australia
  • Novartis Investigative Site
    Liverpool, New South Wales 2170, Australia
  • Novartis Investigative Site
    North Ryde, New South Wales 2109, Australia
  • Novartis Investigative Site
    Parramatta, New South Wales 2150, Australia
  • Novartis Investigative Site
    Strathfield, New South Wales 2135, Australia
  • Novartis Investigative Site
    Sydney, New South Wales 2000, Australia
  • Novartis Investigative Site
    Westmead, New South Wales 2145, Australia
  • Novartis Investigative Site
    Adelaide, South Australia 5000, Australia
  • Novartis Investigative Site
    Hobart, Tasmania 7000, Australia
  • Novartis Investigative Site
    South Launceston, Tasmania 7249, Australia
  • Novartis Investigative Site
    Melbourne, Victoria 3000, Australia
  • Novartis Investigative Site
    Melbourne, Victoria 3002, Australia
  • Novartis Investigative Site
    Nedlands, Western Australia 6009, Australia
09

References and documents

Publications

  • Arnold JJ, Markey CM, Kurstjens NP, Guymer RH. The role of sub-retinal fluid in determining treatment outcomes in patients with neovascular age-related macular degeneration--a phase IV randomised clinical trial with ranibizumab: the FLUID study. BMC Ophthalmol. 2016 Mar 24;16:31. doi: 10.1186/s12886-016-0207-3. PubMed 27009515 ↗

Study documents

  • Study protocol · Jun 19, 2017
  • Statistical analysis plan · Jun 19, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 23, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01972789
Lead sponsor
Novartis Pharmaceuticals
Responsible party
Sponsor
First posted
Oct 30, 2013
Start date
Oct 31, 2013
Primary completion
Feb 28, 2017
Completion
Feb 28, 2017
Results posted
Oct 23, 2019
Last update
Oct 23, 2019

Study contacts

Novartis Pharmaceuticals
study director · Novartis Pharmaceuticals

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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