Polypoidal Choroidal Vasculopathy
Conditions
Brief summary
To compare the short-term effect of intravitreal aflibercept injection between two subtypes of polypoidal choroidal vasculopathy
Detailed description
The subjects were classified into two subtypes (type 1 and type 2 polypoidal choroidal vasculopathy) based on the presence or the absence of both of a feeder and a draining vessels on indocyanine green angiography. All received intravitreal injection of aflibercept (2.0 mg) at baseline and months 1, 2 and 4.
Interventions
DRUGAflibercept
Total 4 times of intravitreal aflibercept injection was performed
DRUGIndocyanine green angiography (intraveonus indocyanine green dye)
At initial visit, indocyanine green angiography was performed. After 1 month of third Aflibercept injection, indocyanine green angiography was performed to evaluate polyp closure.
Sponsors
Yeungnam University College of Medicine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
45 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. symptomatic typical PCV accompanying branch vascular network involving subfoveal area 2. signed informed consent; and 3. over 6 months follow-up period after enrollment.
Exclusion criteria
1. retinal diseases other than PCV 2. extrafoveal PCV not involving subfoveal area 3. massive subretinal hemorrhage blocking polypoidal lesion on ICGA 4. severe media opacity such as senile cataract 5. previous history of intravitreal injection 6. previous intraocular surgery history except cataract surgery which was done more than 3 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Regression Rate of Polyp on Indocyanine Green Angiography | 3 months | Indocyanine green angiography performed initially and at 3 months were used to determine the polyp regression. The definition of complete polyp regression is that the polyps at initial visit disappeared at 3 months on indocyanine green angiography. The partial regression means the polyps remain, but the size decreased \>30%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Best Corrected Visual Acuity | baseline, 3 months, and 6 monthsc | Best corrected visual acuity assessed at baseline, 3 months, and 6 months |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Type 1 Polypoidal Choroidal Vasculopathy Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months from third injection.
At initial visit, indocyanine green angiography was performed. After 1 month of third Aflibercept injection, indocyanine green angiography was performed to evaluate polyp closure. | 16 |
| Type 2 Polypoidal Choroidal Vasculopathy Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months from third injection.
At initial visit, indocyanine green angiography was performed. After 1 month of third Aflibercept injection, indocyanine green angiography was performed to evaluate polyp closure. | 13 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 1 |
Baseline characteristics
| Characteristic | Type 1 Polypoidal Choroidal Vasculopathy | Type 2 Polypoidal Choroidal Vasculopathy | Total |
|---|---|---|---|
| Age, Continuous | 69.7 years STANDARD_DEVIATION 7.4 | 64.2 years STANDARD_DEVIATION 6.6 | 67.2 years STANDARD_DEVIATION 7.5 |
| Region of Enrollment Korea, Republic of | 16 participants | 13 participants | 29 participants |
| Sex: Female, Male Female | 5 Participants | 1 Participants | 6 Participants |
| Sex: Female, Male Male | 11 Participants | 12 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 18 | 0 / 14 |
| serious Total, serious adverse events | 0 / 18 | 0 / 14 |
Outcome results
Primary
Regression Rate of Polyp on Indocyanine Green Angiography
Indocyanine green angiography performed initially and at 3 months were used to determine the polyp regression. The definition of complete polyp regression is that the polyps at initial visit disappeared at 3 months on indocyanine green angiography. The partial regression means the polyps remain, but the size decreased \>30%.
Time frame: 3 months
Population: Participants who were finished 6 months follow up period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Type 1 Polypoidal Choroidal Vasculopathy | Regression Rate of Polyp on Indocyanine Green Angiography | Partial polyp regression | 3 participants |
| Type 1 Polypoidal Choroidal Vasculopathy | Regression Rate of Polyp on Indocyanine Green Angiography | Complete polyp regression | 13 participants |
| Type 1 Polypoidal Choroidal Vasculopathy | Regression Rate of Polyp on Indocyanine Green Angiography | No regression | 0 participants |
| Type 2 Polypoidal Choroidal Vasculopathy | Regression Rate of Polyp on Indocyanine Green Angiography | Complete polyp regression | 4 participants |
| Type 2 Polypoidal Choroidal Vasculopathy | Regression Rate of Polyp on Indocyanine Green Angiography | Partial polyp regression | 7 participants |
| Type 2 Polypoidal Choroidal Vasculopathy | Regression Rate of Polyp on Indocyanine Green Angiography | No regression | 2 participants |
Comparison: The difference of polyp regression rate between two groups were compared.p-value: <0.05Fisher Exact
Secondary
Best Corrected Visual Acuity
Best corrected visual acuity assessed at baseline, 3 months, and 6 months
Time frame: baseline, 3 months, and 6 monthsc
Population: Participants who were finished 6 months follow up period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Type 1 Polypoidal Choroidal Vasculopathy | Best Corrected Visual Acuity | 3 months | 0.39 LogMAR | Standard Deviation 0.36 |
| Type 1 Polypoidal Choroidal Vasculopathy | Best Corrected Visual Acuity | 6 months | 0.44 LogMAR | Standard Deviation 0.26 |
| Type 1 Polypoidal Choroidal Vasculopathy | Best Corrected Visual Acuity | Baseline | 0.76 LogMAR | Standard Deviation 0.41 |
| Type 2 Polypoidal Choroidal Vasculopathy | Best Corrected Visual Acuity | 3 months | 0.54 LogMAR | Standard Deviation 0.34 |
| Type 2 Polypoidal Choroidal Vasculopathy | Best Corrected Visual Acuity | 6 months | 0.49 LogMAR | Standard Deviation 0.36 |
| Type 2 Polypoidal Choroidal Vasculopathy | Best Corrected Visual Acuity | Baseline | 0.62 LogMAR | Standard Deviation 0.3 |
Comparison: best corrected visual acuity was compared between two groupsp-value: <0.05Wilcoxon (Mann-Whitney)