Trial Outcomes & Findings for Short-term Efficacy of Intravitreal Afilibercept Depending on Subtypes of Polypoidal Choroidal Vasculopathy: Polypoidal Choroidal Neovascularization or Idiopathic Choroidal Vasculopathy (NCT NCT02597855)
NCT ID: NCT02597855
Last Updated: 2016-08-18
Results Overview
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%.
Recruitment status
UNKNOWN
Target enrollment
29 participants
Primary outcome timeframe
3 months
Results posted on
2016-08-18
Participant Flow
Participant milestones
| Measure |
Type 1 Polypoidal Choroidal Vasculopathy
Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months. Indocyanine green angiography was used to classify the type of PCV and evaluate the polyp closure rate.
Aflibercept: Total 4 times of intravitreal aflibercept injection was performed
Indocyanine 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.
|
Type 2 Polypoidal Choroidal Vasculopathy
Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months. Indocyanine green angiography was used to classify the type of PCV and evaluate the polyp closure rate.
Aflibercept: Total 4 times of intravitreal aflibercept injection was performed
Indocyanine 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.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
14
|
|
Overall Study
COMPLETED
|
16
|
13
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Type 1 Polypoidal Choroidal Vasculopathy
Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months. Indocyanine green angiography was used to classify the type of PCV and evaluate the polyp closure rate.
Aflibercept: Total 4 times of intravitreal aflibercept injection was performed
Indocyanine 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.
|
Type 2 Polypoidal Choroidal Vasculopathy
Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months. Indocyanine green angiography was used to classify the type of PCV and evaluate the polyp closure rate.
Aflibercept: Total 4 times of intravitreal aflibercept injection was performed
Indocyanine 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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
Baseline Characteristics
Short-term Efficacy of Intravitreal Afilibercept Depending on Subtypes of Polypoidal Choroidal Vasculopathy: Polypoidal Choroidal Neovascularization or Idiopathic Choroidal Vasculopathy
Baseline characteristics by cohort
| Measure |
Type 1 Polypoidal Choroidal Vasculopathy
n=16 Participants
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.
|
Type 2 Polypoidal Choroidal Vasculopathy
n=13 Participants
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.
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.7 years
STANDARD_DEVIATION 7.4 • n=93 Participants
|
64.2 years
STANDARD_DEVIATION 6.6 • n=4 Participants
|
67.2 years
STANDARD_DEVIATION 7.5 • n=27 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
|
Region of Enrollment
Korea, Republic of
|
16 participants
n=93 Participants
|
13 participants
n=4 Participants
|
29 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Participants who were finished 6 months follow up period.
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%.
Outcome measures
| Measure |
Type 1 Polypoidal Choroidal Vasculopathy
n=16 Participants
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.
|
Type 2 Polypoidal Choroidal Vasculopathy
n=13 Participants
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.
|
|---|---|---|
|
Regression Rate of Polyp on Indocyanine Green Angiography
Complete polyp regression
|
13 participants
|
4 participants
|
|
Regression Rate of Polyp on Indocyanine Green Angiography
Partial polyp regression
|
3 participants
|
7 participants
|
|
Regression Rate of Polyp on Indocyanine Green Angiography
No regression
|
0 participants
|
2 participants
|
SECONDARY outcome
Timeframe: baseline, 3 months, and 6 monthscPopulation: Participants who were finished 6 months follow up period.
Best corrected visual acuity assessed at baseline, 3 months, and 6 months
Outcome measures
| Measure |
Type 1 Polypoidal Choroidal Vasculopathy
n=16 Participants
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.
|
Type 2 Polypoidal Choroidal Vasculopathy
n=13 Participants
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.
|
|---|---|---|
|
Best Corrected Visual Acuity
6 months
|
0.44 LogMAR
Standard Deviation 0.26
|
0.49 LogMAR
Standard Deviation 0.36
|
|
Best Corrected Visual Acuity
3 months
|
0.39 LogMAR
Standard Deviation 0.36
|
0.54 LogMAR
Standard Deviation 0.34
|
|
Best Corrected Visual Acuity
Baseline
|
0.76 LogMAR
Standard Deviation 0.41
|
0.62 LogMAR
Standard Deviation 0.30
|
Adverse Events
Type 1 Polypoidal Choroidal Vasculopathy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Type 2 Polypoidal Choroidal Vasculopathy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Min Sagong
Yeungnam University College of Medicine
Phone: 82-53-620-4191
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place