Exudative Age-related Macular Degeneration, Polypoidal Choroidal Vasculopathy
Conditions
Brief summary
Effects of VEGF Trap-Eye (aflibercept) in treatment-naive polypoidal choroidal vasculopathy (PCV) will be evaluated.
Detailed description
Efficacy of VEGF Trap-Eye (aflibercept, Eylea) for exudative age-related macular degeneration (AMD) was demonstrated in the phase III VIEW study. Polypoidal choroidal vasculopathy (PCV) is considered as a subtype of exudative AMD, however it is reportedly different from choroidal new vessels based on the histologic studies. The aim of this study is to evaluate effects of VEGF Trap-Eye in treatment of PCV, which was diagnosed using indocyanine green (ICG) angiography. VEGF Trap-Eye will be injected intravitreally bimonthly after 3 monthly loading dose for 12 months in treatment-naive PCV patients. The efficacy will be evaluated on preserving visual acuity and improving angiographic features at 12 months.
Interventions
DRUGaflibercept
Aflibercept is injected intravitreally though the pars plana using 30G needle-attached syringe.
Sponsors
Bayer
Pusan National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Submacular PCV diagnosed using ICG angiography with no previous treatment (branching vascular network with or without polypoidal dilation in ICG angiography) * Presence of signs of recent activity of PCV 1. Visual acuity between 20/40 and 20/320 2. Active leakage in fluorescein angiography 3. Presence of any fluid in OCT(optical coherence tomography)-intraretinal, subretinal, sub-retinal pigment epithelial
Exclusion criteria
1. Extramacular PCV 2. Subretinal hemorrhage or other retinal lesions blocking angiographic characteristics in more than 50% area of PCV lesion. 3. Previous treatment of intravitreal injections (anti-VEGF, steroid or other agents) 4. Previous treatment of photodynamic therapy 5. Previous ocular surgery except cataract surgery before 3 or more months 6. Presence of exudative AMD in the other eyes requiring anti-VEGF treatment (Intravitreal bevacizumab was reported to affect the other eye.) 7. Presence of other ocular diseases which may affect visual acuity (glaucoma, cataract with opacity involving visual axis, etc) 8. Presence of uncontrolled systemic disease (diabetes mellitus, hypertension, ischemic heart disease, cerebral infarction, etc) 9. Patients who cannot understand or conform to the study protocol. 10. Patients who refuse to agree to the informed consent. 11. Patients with contraindication to aflibercept * Ocular or periocular infection * Active severe intraocular inflammation * Known hypersensitivity to aflibercept or to any of the excipients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Lose Visual Acuity Less Than 15 Letters | 12 months | Visual acuity was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. The ETDRS chart includes 100 letters as the maximum possible score, and 0 letters read as the minimum possible score. Visual acuity of 85 letters is equivalent to 20/20. Higher scores represents better functioning. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Visual Acuity From Baseline to 12 Months | Baseline and 12 months | Mean changes of visual acuity in ETDRS letters. Visual acuity was assessed using ETDRS chart. The ETDRS chart includes 100 letters as the maximum possible score, and 0 letters read as the minimum possible score. Higher scores represents better functioning. A change of 5 letters is equivalent to a 1-line change. |
| Percentage of Patients With Visual Acuity >=20/200 | 12 months | Visual acuity was assessed using ETDRS chart. The ETDRS chart includes 100 letters as the maximum possible score, and 0 letters read as the minimum possible score. Higher scores represents better functioning. Percentage of patients with visual acuity 35 ETDRS letters (equivalent to 20/200) or better was calculated. |
| Percentage of Patients With Visual Acuity >=20/40 | 12 months | Visual acuity was assessed using ETDRS chart. The ETDRS chart includes 100 letters as the maximum possible score, and 0 letters read as the minimum possible score. Higher scores represents better functioning. Percentage of patients with visual acuity 70 ETDRS letters (equivalent to 20/40) or better was calculated. |
| Percentage of Patients Having Complete Resulution of Polypoidal Lesion in ICG Angiography | 12 months | ICG angiography was assessed at 12 months. when no polypoidal lesion was detected, it was defined as complete resolution. |
| VFQ (Visual Function Questionaire)-25 Score | 12 months | Quality of life was assessed using VFQ -25 score . The VFQ-25 includes 25 questions, and the total score ranges from 0 to 100. Higher scores represents better functioning. |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Aflibercept Aflibercept 2 mg is injected into the vitreous cavity. Injections are given monthly three times, then are given bi-monthly to 12 months (month 0, 1, 2, 4, 6, 8, and 10; total 7 injections for 1 year).
aflibercept: Aflibercept is injected intravitreally though the pars plana using 30G needle-attached syringe. | 48 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Aflibercept |
|---|---|
| Age, Continuous | 68.3 years |
| Sex: Female, Male Female | 31 Participants |
| Sex: Female, Male Male | 17 Participants |
| Visual acuity | 54.4 letters STANDARD_DEVIATION 18.1 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 4 / 47 |
| serious Total, serious adverse events | 1 / 47 |
Outcome results
Primary
Percentage of Patients Lose Visual Acuity Less Than 15 Letters
Visual acuity was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. The ETDRS chart includes 100 letters as the maximum possible score, and 0 letters read as the minimum possible score. Visual acuity of 85 letters is equivalent to 20/20. Higher scores represents better functioning.
Time frame: 12 months
Population: Among 45 patients who completed the study, data of 5 were inadequate for the analysis. Forty patients were included in the analysis as per protocol set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aflibercept | Percentage of Patients Lose Visual Acuity Less Than 15 Letters | 87.5 percentage of patients |
Secondary
Change in Visual Acuity From Baseline to 12 Months
Mean changes of visual acuity in ETDRS letters. Visual acuity was assessed using ETDRS chart. The ETDRS chart includes 100 letters as the maximum possible score, and 0 letters read as the minimum possible score. Higher scores represents better functioning. A change of 5 letters is equivalent to a 1-line change.
Time frame: Baseline and 12 months
Population: Among 45 patients who completed the study, data of 5 were inadequate for the analysis. Forty patients were included in the analysis as per protocol set.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Aflibercept | Change in Visual Acuity From Baseline to 12 Months | 9 letters |
Secondary
Percentage of Patients Having Complete Resulution of Polypoidal Lesion in ICG Angiography
ICG angiography was assessed at 12 months. when no polypoidal lesion was detected, it was defined as complete resolution.
Time frame: 12 months
Population: Among 45 patients who completed the study, data of 6 were inadequate for the analysis. 39 patients were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aflibercept | Percentage of Patients Having Complete Resulution of Polypoidal Lesion in ICG Angiography | 66.7 percentage of patients |
Secondary
Percentage of Patients With Visual Acuity >=20/200
Visual acuity was assessed using ETDRS chart. The ETDRS chart includes 100 letters as the maximum possible score, and 0 letters read as the minimum possible score. Higher scores represents better functioning. Percentage of patients with visual acuity 35 ETDRS letters (equivalent to 20/200) or better was calculated.
Time frame: 12 months
Population: Among 45 patients who completed the study, data of 5 were inadequate for the analysis. Forty patients were included in the analysis as per protocol set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aflibercept | Percentage of Patients With Visual Acuity >=20/200 | 95.0 percentage of patients |
Secondary
Percentage of Patients With Visual Acuity >=20/40
Visual acuity was assessed using ETDRS chart. The ETDRS chart includes 100 letters as the maximum possible score, and 0 letters read as the minimum possible score. Higher scores represents better functioning. Percentage of patients with visual acuity 70 ETDRS letters (equivalent to 20/40) or better was calculated.
Time frame: 12 months
Population: Among 45 patients who completed the study, data of 5 were inadequate for the analysis. Forty patients were included in the analysis as per protocol set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aflibercept | Percentage of Patients With Visual Acuity >=20/40 | 52.5 percentage of patients |
Secondary
VFQ (Visual Function Questionaire)-25 Score
Quality of life was assessed using VFQ -25 score . The VFQ-25 includes 25 questions, and the total score ranges from 0 to 100. Higher scores represents better functioning.
Time frame: 12 months
Population: Among 45 patients who completed the study, data of 5 were inadequate for the analysis. Forty patients were included in the analysis as per protocol set.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Aflibercept | VFQ (Visual Function Questionaire)-25 Score | 72.6 scores on a scale |