Subfoveal Choroidal Neovascularization CNV Secondary to Wet Age-related Macular Degeneration AMD
Conditions
Keywords
Subfoveal choroidal neovascularization (CNV), wet age-related macular degeneration(AMD), inject and extend, retinal fluid
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
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
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
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
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Best-corrected Visual Acuity (BCVA) From Baseline to 24 Months. | Baseline to month 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 month 24. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Baseline or following consent | 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. |
| Mean Change in BCVA From Baseline to Month 12. | 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. |
| Mean Change in Central Retinal Thickness (CRT) From Baseline to Month 12 and 24. | Baseline to month 12 and month 24 | Central retinal thickness will be measured by Optical Coherence Tomography (OCT) at every visit. |
| Mean Number of Injections From Baseline to Month 12 and 24 | Baseline to month 12 to month 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. |
| Mean Change in Area of New and Existing Geographic Atrophy From Baseline to Month 12 and 24. | Baseline to months 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. |
| The Number of Times a Participant Needs to Return to Monthly Treatments During the 24 Months. | Month 24 | 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. |
| Proportion of Patients Showing no IRF and SRF at Months 2, 12 and 24. | Months 2, 12 and 24. | Assessed by Optical Coherence Tomography (OCT) and confirmed by a central reading centre. |
| Proportion of Patients Showing Greater Than or Equal to 15 Letters Early Treatment Diabetic Retinopathy (ETDRS) Gain From Baseline to Month 12 and 24. | Baseline to months 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. |
| Proportion of Patients Showing Less Than 15 Letters ETDRS Loss From Baseline to Month 12 and 24. | Baseline to months 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. |
| Proportion of Patients With Both SRF (Sub-retinal Fluid) and IRF (Intra-retinal Fluid) Who Despite Monthly Treatment do Not Resolve Their SRF | Month 12 and 24 | Assessed by Optical Coherence Tomography (OCT) and confirmed by a central reading centre. |
| Proportion of Patients Showing Newly Developed Geographic Atrophy (GA) at Months 12 and 24 | 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 |
Countries
Australia
Participant flow
Recruitment details
a total of 349 subjects were randomized to the study (intensive arm, 174; relaxed arm, 175). relaxed 173).
Pre-assignment details
Two randomized subjects, 1 in each treatment group, did not receive study treatment and were excluded from the safety set (347 subjects: intensive arm, 173; relaxed arm, 174). 2 subjects did not have correctly measured BCVA at baseline and were excluded from the FAS (345 subjects: intensive 172;
Participants by arm
| Arm | Count |
|---|---|
| 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. | 174 |
| 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. | 175 |
| Total | 349 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 11 | 4 |
| Overall Study | Death | 7 | 5 |
| Overall Study | Lost to Follow-up | 4 | 7 |
| Overall Study | Physician Decision | 3 | 2 |
| Overall Study | Protocol deviation | 1 | 0 |
| Overall Study | Subject withdrew consent | 14 | 12 |
Baseline characteristics
| Characteristic | Relaxed Retinal Fluid Regimen | Total | Intensive Retinal Fluid Regimen |
|---|---|---|---|
| Age, Continuous | 78.8 Years STANDARD_DEVIATION 8.17 | 79 Years STANDARD_DEVIATION 8.12 | 79.3 Years STANDARD_DEVIATION 8.12 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 12 Participants | 9 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) White | 171 Participants | 334 Participants | 163 Participants |
| Sex: Female, Male Female | 89 Participants | 189 Participants | 100 Participants |
| Sex: Female, Male Male | 86 Participants | 160 Participants | 74 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 7 / 173 | 5 / 174 |
| other Total, other adverse events | 109 / 173 | 114 / 174 |
| serious Total, serious adverse events | 58 / 173 | 58 / 174 |
Outcome results
Primary
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
Population: Full Analysis Set (FAS): The Full Analysis Set (FAS) compromises all subjects randomised and whom have at least one post-Baseline efficacy value for the primary endpoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intensive Retinal Fluid Regimen | Mean Change in Best-corrected Visual Acuity (BCVA) From Baseline to 24 Months. | 3.2 Letters | Standard Deviation 16.51 |
| Relaxed Retinal Fluid Regimen | Mean Change in Best-corrected Visual Acuity (BCVA) From Baseline to 24 Months. | 2.5 Letters | Standard Deviation 16.56 |
p-value: 0.78795% CI: [-2.51, 3.32]Mixed Models Analysis
Secondary
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.
Population: Full Analysis Set (FAS): The Full Analysis Set (FAS) compromises all subjects randomised and whom have at least one post-Baseline efficacy value for the primary endpoint
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intensive Retinal Fluid Regimen | Mean Change in Area of New and Existing Geographic Atrophy From Baseline to Month 12 and 24. | Month 12 | 0.8 mm^2 | Standard Deviation 2.13 |
| Intensive Retinal Fluid Regimen | Mean Change in Area of New and Existing Geographic Atrophy From Baseline to Month 12 and 24. | Month 24 | 1.5 mm^2 | Standard Deviation 3.18 |
| Relaxed Retinal Fluid Regimen | Mean Change in Area of New and Existing Geographic Atrophy From Baseline to Month 12 and 24. | Month 12 | 0.7 mm^2 | Standard Deviation 1.8 |
| Relaxed Retinal Fluid Regimen | Mean Change in Area of New and Existing Geographic Atrophy From Baseline to Month 12 and 24. | Month 24 | 1.2 mm^2 | Standard Deviation 2.62 |
p-value: 0.33895% CI: [-0.28, 0.8]Mixed Models Analysis
Secondary
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
Population: Full Analysis Set (FAS): The Full Analysis Set (FAS) compromises all subjects randomised and whom have at least one post-Baseline efficacy value for the primary endpoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intensive Retinal Fluid Regimen | Mean Change in BCVA From Baseline to Month 12. | 4.6 Letters | Standard Deviation 14.69 |
| Relaxed Retinal Fluid Regimen | Mean Change in BCVA From Baseline to Month 12. | 3.9 Letters | Standard Deviation 12.73 |
p-value: 0.83395% CI: [-3.2, 2.58]Mixed Models Analysis
Secondary
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
Population: Full Analysis Set (FAS): The Full Analysis Set (FAS) compromises all subjects randomised and whom have at least one post-Baseline efficacy value for the primary endpoint
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intensive Retinal Fluid Regimen | Mean Change in Central Retinal Thickness (CRT) From Baseline to Month 12 and 24. | Month 12 | -147.1 μm | Standard Deviation 168.33 |
| Intensive Retinal Fluid Regimen | Mean Change in Central Retinal Thickness (CRT) From Baseline to Month 12 and 24. | Month 24 | -158.9 μm | Standard Deviation 170.44 |
| Relaxed Retinal Fluid Regimen | Mean Change in Central Retinal Thickness (CRT) From Baseline to Month 12 and 24. | Month 12 | -125.6 μm | Standard Deviation 133.08 |
| Relaxed Retinal Fluid Regimen | Mean Change in Central Retinal Thickness (CRT) From Baseline to Month 12 and 24. | Month 24 | -126.9 μm | Standard Deviation 140.01 |
p-value: 0.05495% CI: [-43.17, 0.39]Mixed Models Analysis
Secondary
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.
Population: Full Analysis Set (FAS): The Full Analysis Set (FAS) compromises all subjects randomised and whom have at least one post-Baseline efficacy value for the primary endpoint
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intensive Retinal Fluid Regimen | Mean Number of Injections From Baseline to Month 12 and 24 | Month 12 | 9.5 Injections | Standard Deviation 2.6 |
| Intensive Retinal Fluid Regimen | Mean Number of Injections From Baseline to Month 12 and 24 | Month 24 | 17 Injections | Standard Deviation 6.48 |
| Relaxed Retinal Fluid Regimen | Mean Number of Injections From Baseline to Month 12 and 24 | Month 12 | 8.9 Injections | Standard Deviation 2.25 |
| Relaxed Retinal Fluid Regimen | Mean Number of Injections From Baseline to Month 12 and 24 | Month 24 | 15.8 Injections | Standard Deviation 5.91 |
p-value: 0.00195% CI: [1.04, 1.18]Mixed Model
Secondary
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
Population: Full Analysis Set (FAS): The Full Analysis Set (FAS) compromises all subjects randomized and whom have at least one post-Baseline efficacy value for the primary endpoint
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intensive Retinal Fluid Regimen | 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. | RS13278062 TT | 36 Participants |
| Intensive Retinal Fluid Regimen | 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. | RS10490924 GT | 56 Participants |
| Intensive Retinal Fluid Regimen | 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. | RS10490924 TT | 24 Participants |
| Intensive Retinal Fluid Regimen | 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. | RS1061170 CC | 35 Participants |
| Intensive Retinal Fluid Regimen | 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. | RS1061170 CT | 61 Participants |
| Intensive Retinal Fluid Regimen | 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. | RS1061170 TT | 29 Participants |
| Intensive Retinal Fluid Regimen | 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. | RS10737680 AA | 68 Participants |
| Intensive Retinal Fluid Regimen | 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. | RS10737680 AC | 48 Participants |
| Intensive Retinal Fluid Regimen | 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. | RS10737680 CC | 9 Participants |
| Intensive Retinal Fluid Regimen | 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. | RS11200638 AA | 21 Participants |
| Intensive Retinal Fluid Regimen | 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. | RS11200638 AG | 58 Participants |
| Intensive Retinal Fluid Regimen | 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. | RS11200638 GG | 46 Participants |
| Intensive Retinal Fluid Regimen | 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. | RS121913059 CC | 124 Participants |
| Intensive Retinal Fluid Regimen | 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. | RS121913059 CT | 1 Participants |
| Intensive Retinal Fluid Regimen | 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. | RS13278062 GG | 29 Participants |
| Intensive Retinal Fluid Regimen | 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. | RS13278062 GT | 60 Participants |
| Intensive Retinal Fluid Regimen | 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. | RS10490924 GG | 44 Participants |
| Intensive Retinal Fluid Regimen | 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. | RS141853578 CC | 125 Participants |
| Intensive Retinal Fluid Regimen | 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. | RS147859257 GT | 2 Participants |
| Intensive Retinal Fluid Regimen | 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. | RS147859257 TT | 123 Participants |
| Intensive Retinal Fluid Regimen | 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. | RS1864163 AA | 9 Participants |
| Intensive Retinal Fluid Regimen | 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. | RS1864163 AG | 29 Participants |
| Intensive Retinal Fluid Regimen | 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. | RS1864163 GG | 85 Participants |
| Intensive Retinal Fluid Regimen | 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. | RS2230199 CC | 81 Participants |
| Intensive Retinal Fluid Regimen | 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. | RS2230199 CG | 37 Participants |
| Intensive Retinal Fluid Regimen | 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. | RS2230199 GG | 6 Participants |
| Intensive Retinal Fluid Regimen | 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. | RS3130783 AA | 77 Participants |
| Intensive Retinal Fluid Regimen | 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. | RS3130783 AG | 44 Participants |
| Intensive Retinal Fluid Regimen | 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. | RS3130783 GG | 4 Participants |
| Intensive Retinal Fluid Regimen | 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. | RS334353 GG | 6 Participants |
| Intensive Retinal Fluid Regimen | 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. | RS334353 GT | 41 Participants |
| Intensive Retinal Fluid Regimen | 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. | RS334353 TT | 78 Participants |
| Intensive Retinal Fluid Regimen | 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. | RS3812111 AA | 31 Participants |
| Intensive Retinal Fluid Regimen | 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. | RS3812111 AT | 57 Participants |
| Intensive Retinal Fluid Regimen | 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. | RS3812111 TT | 36 Participants |
| Intensive Retinal Fluid Regimen | 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. | RS429608 AA | 2 Participants |
| Intensive Retinal Fluid Regimen | 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. | RS429608 AG | 19 Participants |
| Intensive Retinal Fluid Regimen | 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. | RS429608 GG | 103 Participants |
| Intensive Retinal Fluid Regimen | 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. | RS4420638 AA | 89 Participants |
| Intensive Retinal Fluid Regimen | 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. | RS4420638 AG | 35 Participants |
| Intensive Retinal Fluid Regimen | 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. | RS4698775 GG | 11 Participants |
| Intensive Retinal Fluid Regimen | 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. | RS4698775 GT | 53 Participants |
| Intensive Retinal Fluid Regimen | 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. | RS4698775 TT | 60 Participants |
| Intensive Retinal Fluid Regimen | 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. | RS5749482 CC | 4 Participants |
| Intensive Retinal Fluid Regimen | 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. | RS5749482 CG | 26 Participants |
| Intensive Retinal Fluid Regimen | 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. | RS5749482 GG | 95 Participants |
| Intensive Retinal Fluid Regimen | 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. | RS6795735 CC | 43 Participants |
| Intensive Retinal Fluid Regimen | 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. | RS6795735 CT | 53 Participants |
| Intensive Retinal Fluid Regimen | 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. | RS6795735 TT | 28 Participants |
| Intensive Retinal Fluid Regimen | 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. | RS8017304 AA | 57 Participants |
| Intensive Retinal Fluid Regimen | 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. | RS8017304 AG | 53 Participants |
| Intensive Retinal Fluid Regimen | 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. | RS8017304 GG | 15 Participants |
| Intensive Retinal Fluid Regimen | 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. | RS8135665 CC | 68 Participants |
| Intensive Retinal Fluid Regimen | 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. | RS8135665 CT | 50 Participants |
| Intensive Retinal Fluid Regimen | 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. | RS8135665 TT | 6 Participants |
| Intensive Retinal Fluid Regimen | 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. | RS920915 CC | 32 Participants |
| Intensive Retinal Fluid Regimen | 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. | RS920915 CG | 64 Participants |
| Intensive Retinal Fluid Regimen | 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. | RS920915 GG | 28 Participants |
| Intensive Retinal Fluid Regimen | 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. | RS943080 CC | 27 Participants |
| Intensive Retinal Fluid Regimen | 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. | RS943080 CT | 57 Participants |
| Intensive Retinal Fluid Regimen | 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. | RS943080 TT | 40 Participants |
| Intensive Retinal Fluid Regimen | 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. | RS9542236 CC | 26 Participants |
| Intensive Retinal Fluid Regimen | 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. | RS9542236 CT | 61 Participants |
| Intensive Retinal Fluid Regimen | 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. | RS9542236 TT | 38 Participants |
| Relaxed Retinal Fluid Regimen | 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. | RS9542236 TT | 38 Participants |
| Relaxed Retinal Fluid Regimen | 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. | RS10490924 GG | 47 Participants |
| Relaxed Retinal Fluid Regimen | 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. | RS3812111 AA | 16 Participants |
| Relaxed Retinal Fluid Regimen | 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. | RS10490924 GT | 57 Participants |
| Relaxed Retinal Fluid Regimen | 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. | RS6795735 TT | 27 Participants |
| Relaxed Retinal Fluid Regimen | 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. | RS10490924 TT | 23 Participants |
| Relaxed Retinal Fluid Regimen | 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. | RS3812111 AT | 52 Participants |
| Relaxed Retinal Fluid Regimen | 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. | RS1061170 CC | 43 Participants |
| Relaxed Retinal Fluid Regimen | 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. | RS920915 CG | 60 Participants |
| Relaxed Retinal Fluid Regimen | 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. | RS1061170 CT | 61 Participants |
| Relaxed Retinal Fluid Regimen | 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. | RS3812111 TT | 54 Participants |
| Relaxed Retinal Fluid Regimen | 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. | RS1061170 TT | 21 Participants |
| Relaxed Retinal Fluid Regimen | 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. | RS8017304 AA | 65 Participants |
| Relaxed Retinal Fluid Regimen | 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. | RS10737680 AA | 82 Participants |
| Relaxed Retinal Fluid Regimen | 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. | RS429608 AA | 1 Participants |
| Relaxed Retinal Fluid Regimen | 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. | RS10737680 AC | 37 Participants |
| Relaxed Retinal Fluid Regimen | 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. | RS943080 TT | 28 Participants |
| Relaxed Retinal Fluid Regimen | 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. | RS10737680 CC | 8 Participants |
| Relaxed Retinal Fluid Regimen | 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. | RS429608 AG | 19 Participants |
| Relaxed Retinal Fluid Regimen | 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. | RS11200638 AA | 23 Participants |
| Relaxed Retinal Fluid Regimen | 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. | RS8017304 AG | 51 Participants |
| Relaxed Retinal Fluid Regimen | 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. | RS11200638 AG | 58 Participants |
| Relaxed Retinal Fluid Regimen | 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. | RS429608 GG | 103 Participants |
| Relaxed Retinal Fluid Regimen | 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. | RS11200638 GG | 46 Participants |
| Relaxed Retinal Fluid Regimen | 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. | RS920915 GG | 34 Participants |
| Relaxed Retinal Fluid Regimen | 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. | RS121913059 CC | 127 Participants |
| Relaxed Retinal Fluid Regimen | 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. | RS4420638 AA | 96 Participants |
| Relaxed Retinal Fluid Regimen | 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. | RS121913059 CT | 0 Participants |
| Relaxed Retinal Fluid Regimen | 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. | RS8017304 GG | 11 Participants |
| Relaxed Retinal Fluid Regimen | 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. | RS13278062 GG | 17 Participants |
| Relaxed Retinal Fluid Regimen | 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. | RS4420638 AG | 31 Participants |
| Relaxed Retinal Fluid Regimen | 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. | RS13278062 GT | 75 Participants |
| Relaxed Retinal Fluid Regimen | 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. | RS9542236 CT | 63 Participants |
| Relaxed Retinal Fluid Regimen | 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. | RS13278062 TT | 35 Participants |
| Relaxed Retinal Fluid Regimen | 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. | RS4698775 GG | 8 Participants |
| Relaxed Retinal Fluid Regimen | 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. | RS141853578 CC | 125 Participants |
| Relaxed Retinal Fluid Regimen | 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. | RS8135665 CC | 79 Participants |
| Relaxed Retinal Fluid Regimen | 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. | RS147859257 GT | 1 Participants |
| Relaxed Retinal Fluid Regimen | 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. | RS4698775 GT | 71 Participants |
| Relaxed Retinal Fluid Regimen | 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. | RS147859257 TT | 126 Participants |
| Relaxed Retinal Fluid Regimen | 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. | RS943080 CC | 35 Participants |
| Relaxed Retinal Fluid Regimen | 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. | RS1864163 AA | 7 Participants |
| Relaxed Retinal Fluid Regimen | 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. | RS4698775 TT | 47 Participants |
| Relaxed Retinal Fluid Regimen | 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. | RS1864163 AG | 46 Participants |
| Relaxed Retinal Fluid Regimen | 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. | RS8135665 CT | 41 Participants |
| Relaxed Retinal Fluid Regimen | 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. | RS1864163 GG | 73 Participants |
| Relaxed Retinal Fluid Regimen | 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. | RS5749482 CC | 1 Participants |
| Relaxed Retinal Fluid Regimen | 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. | RS2230199 CC | 67 Participants |
| Relaxed Retinal Fluid Regimen | 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. | RS9542236 CC | 26 Participants |
| Relaxed Retinal Fluid Regimen | 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. | RS2230199 CG | 52 Participants |
| Relaxed Retinal Fluid Regimen | 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. | RS5749482 CG | 26 Participants |
| Relaxed Retinal Fluid Regimen | 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. | RS2230199 GG | 8 Participants |
| Relaxed Retinal Fluid Regimen | 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. | RS8135665 TT | 7 Participants |
| Relaxed Retinal Fluid Regimen | 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. | RS3130783 AA | 91 Participants |
| Relaxed Retinal Fluid Regimen | 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. | RS5749482 GG | 100 Participants |
| Relaxed Retinal Fluid Regimen | 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. | RS3130783 AG | 32 Participants |
| Relaxed Retinal Fluid Regimen | 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. | RS943080 CT | 64 Participants |
| Relaxed Retinal Fluid Regimen | 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. | RS3130783 GG | 4 Participants |
| Relaxed Retinal Fluid Regimen | 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. | RS6795735 CC | 37 Participants |
| Relaxed Retinal Fluid Regimen | 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. | RS334353 GG | 11 Participants |
| Relaxed Retinal Fluid Regimen | 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. | RS920915 CC | 33 Participants |
| Relaxed Retinal Fluid Regimen | 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. | RS334353 GT | 45 Participants |
| Relaxed Retinal Fluid Regimen | 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. | RS6795735 CT | 63 Participants |
| Relaxed Retinal Fluid Regimen | 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. | RS334353 TT | 71 Participants |
Secondary
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.
Population: Full Analysis Set (FAS): The Full Analysis Set (FAS) compromises all subjects randomized and whom have at least one post-Baseline efficacy value for the primary endpoint
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intensive Retinal Fluid Regimen | Proportion of Patients Showing Greater Than or Equal to 15 Letters Early Treatment Diabetic Retinopathy (ETDRS) Gain From Baseline to Month 12 and 24. | Month 12 | 29 Participants |
| Intensive Retinal Fluid Regimen | Proportion of Patients Showing Greater Than or Equal to 15 Letters Early Treatment Diabetic Retinopathy (ETDRS) Gain From Baseline to Month 12 and 24. | Month 24 | 25 Participants |
| Relaxed Retinal Fluid Regimen | Proportion of Patients Showing Greater Than or Equal to 15 Letters Early Treatment Diabetic Retinopathy (ETDRS) Gain From Baseline to Month 12 and 24. | Month 12 | 24 Participants |
| Relaxed Retinal Fluid Regimen | Proportion of Patients Showing Greater Than or Equal to 15 Letters Early Treatment Diabetic Retinopathy (ETDRS) Gain From Baseline to Month 12 and 24. | Month 24 | 24 Participants |
p-value: 0.61595% CI: [0.42, 1.66]Regression, Logistic
Secondary
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
Population: Full Analysis Set (FAS): The Full Analysis Set (FAS) compromises all subjects randomized and whom have at least one post-Baseline efficacy value for the primary endpoint
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intensive Retinal Fluid Regimen | Proportion of Patients Showing Less Than 15 Letters ETDRS Loss From Baseline to Month 12 and 24. | Month 12 | 142 Participants |
| Intensive Retinal Fluid Regimen | Proportion of Patients Showing Less Than 15 Letters ETDRS Loss From Baseline to Month 12 and 24. | Month 24 | 129 Participants |
| Relaxed Retinal Fluid Regimen | Proportion of Patients Showing Less Than 15 Letters ETDRS Loss From Baseline to Month 12 and 24. | Month 12 | 141 Participants |
| Relaxed Retinal Fluid Regimen | Proportion of Patients Showing Less Than 15 Letters ETDRS Loss From Baseline to Month 12 and 24. | Month 24 | 132 Participants |
p-value: 0.81995% CI: [0.54, 2.18]Regression, Logistic
Secondary
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
Population: Full Analysis Set (FAS): The Full Analysis Set (FAS) compromises all subjects randomized and whom have at least one post-Baseline efficacy value for the primary endpoint
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intensive Retinal Fluid Regimen | Proportion of Patients Showing Newly Developed Geographic Atrophy (GA) at Months 12 and 24 | Month 12, GA present | 25 Participants |
| Intensive Retinal Fluid Regimen | Proportion of Patients Showing Newly Developed Geographic Atrophy (GA) at Months 12 and 24 | Month 12, GA absent | 103 Participants |
| Intensive Retinal Fluid Regimen | Proportion of Patients Showing Newly Developed Geographic Atrophy (GA) at Months 12 and 24 | Month 24, GA present | 32 Participants |
| Intensive Retinal Fluid Regimen | Proportion of Patients Showing Newly Developed Geographic Atrophy (GA) at Months 12 and 24 | Month 24, GA absent | 80 Participants |
| Relaxed Retinal Fluid Regimen | Proportion of Patients Showing Newly Developed Geographic Atrophy (GA) at Months 12 and 24 | Month 24, GA absent | 94 Participants |
| Relaxed Retinal Fluid Regimen | Proportion of Patients Showing Newly Developed Geographic Atrophy (GA) at Months 12 and 24 | Month 12, GA present | 18 Participants |
| Relaxed Retinal Fluid Regimen | Proportion of Patients Showing Newly Developed Geographic Atrophy (GA) at Months 12 and 24 | Month 24, GA present | 29 Participants |
| Relaxed Retinal Fluid Regimen | Proportion of Patients Showing Newly Developed Geographic Atrophy (GA) at Months 12 and 24 | Month 12, GA absent | 110 Participants |
Comparison: Month 12p-value: 0.28495% CI: [0.74, 2.8]Regression, Logistic
Comparison: Month 24p-value: 0.40795% CI: [0.71, 2.33]Regression, Logistic
Secondary
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.
Population: Full Analysis Set (FAS): The Full Analysis Set (FAS) compromises all subjects randomized and whom have at least one post-Baseline efficacy value for the primary endpoint
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intensive Retinal Fluid Regimen | Proportion of Patients Showing no IRF and SRF at Months 2, 12 and 24. | Month 2 | 106 Participants |
| Intensive Retinal Fluid Regimen | Proportion of Patients Showing no IRF and SRF at Months 2, 12 and 24. | month 12 | 87 Participants |
| Intensive Retinal Fluid Regimen | Proportion of Patients Showing no IRF and SRF at Months 2, 12 and 24. | Month 24 | 64 Participants |
| Relaxed Retinal Fluid Regimen | Proportion of Patients Showing no IRF and SRF at Months 2, 12 and 24. | Month 2 | 93 Participants |
| Relaxed Retinal Fluid Regimen | Proportion of Patients Showing no IRF and SRF at Months 2, 12 and 24. | month 12 | 72 Participants |
| Relaxed Retinal Fluid Regimen | Proportion of Patients Showing no IRF and SRF at Months 2, 12 and 24. | Month 24 | 56 Participants |
p-value: 0.21795% CI: [0.12, 1.04]Regression, Logistic
Secondary
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
Population: Full Analysis Set (FAS): The Full Analysis Set (FAS) compromises all subjects randomized and whom have at least one post-Baseline efficacy value for the primary endpoint
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intensive Retinal Fluid Regimen | Proportion of Patients With Both SRF (Sub-retinal Fluid) and IRF (Intra-retinal Fluid) Who Despite Monthly Treatment do Not Resolve Their SRF | Month 12 | 3 Participants |
| Intensive Retinal Fluid Regimen | Proportion of Patients With Both SRF (Sub-retinal Fluid) and IRF (Intra-retinal Fluid) Who Despite Monthly Treatment do Not Resolve Their SRF | Month 24 | 1 Participants |
| Relaxed Retinal Fluid Regimen | Proportion of Patients With Both SRF (Sub-retinal Fluid) and IRF (Intra-retinal Fluid) Who Despite Monthly Treatment do Not Resolve Their SRF | Month 12 | 2 Participants |
| Relaxed Retinal Fluid Regimen | Proportion of Patients With Both SRF (Sub-retinal Fluid) and IRF (Intra-retinal Fluid) Who Despite Monthly Treatment do Not Resolve Their SRF | Month 24 | 2 Participants |
p-value: 0.56595% CI: [0.03, 630.5]Regression, Logistic
Secondary
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
Population: Full Analysis Set (FAS): The Full Analysis Set (FAS) compromises all subjects randomized and whom have at least one post-Baseline efficacy value for the primary endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intensive Retinal Fluid Regimen | The Number of Times a Participant Needs to Return to Monthly Treatments During the 24 Months. | 10.6 Visits | Standard Deviation 8.34 |
| Relaxed Retinal Fluid Regimen | The Number of Times a Participant Needs to Return to Monthly Treatments During the 24 Months. | 7.6 Visits | Standard Deviation 8.09 |
p-value: 0.03495% CI: [1.03, 1.9]Regression, Logistic