Trial Outcomes & Findings for Effect of Intravitreal VEGF-Trap Eye on Polypoidal Choroidal Vasculopathy (NCT NCT01950741)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

48 participants

Primary outcome timeframe

12 months

Results posted on

2016-04-29

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	48
Overall Study COMPLETED	45
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Lost to Follow-up	1
Overall Study Death	1
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Effect of Intravitreal VEGF-Trap Eye on Polypoidal Choroidal Vasculopathy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aflibercept n=48 Participants 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.
Age, Continuous	68.3 years n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Visual acuity	54.4 letters STANDARD_DEVIATION 18.1 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Aflibercept n=40 Participants 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.
Percentage of Patients Lose Visual Acuity Less Than 15 Letters	87.5 percentage of patients

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Aflibercept n=40 Participants 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.
Change in Visual Acuity From Baseline to 12 Months	9 letters Interval -33.0 to 37.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Aflibercept n=40 Participants 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.
Percentage of Patients With Visual Acuity >=20/200	95.0 percentage of patients

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Aflibercept n=40 Participants 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.
Percentage of Patients With Visual Acuity >=20/40	52.5 percentage of patients

SECONDARY outcome

Timeframe: 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.

ICG angiography was assessed at 12 months. when no polypoidal lesion was detected, it was defined as complete resolution.

Outcome measures

Outcome measures
Measure	Aflibercept n=39 Participants 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.
Percentage of Patients Having Complete Resulution of Polypoidal Lesion in ICG Angiography	66.7 percentage of patients

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Aflibercept n=40 Participants 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.
VFQ (Visual Function Questionaire)-25 Score	72.6 scores on a scale Interval 67.0 to 77.0

Adverse Events

Aflibercept

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Aflibercept n=47 participants at risk 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. Among 48 patients enrolled, one patient withdrew the consent before undergoing the first injection. Therefore the adverse event was assessed in 47 patients.
Respiratory, thoracic and mediastinal disorders Death	2.1% 1/47 • Number of events 1 • Adverse events data was collected during the study perioid, or 1 year.

Other adverse events

Other adverse events
Measure	Aflibercept n=47 participants at risk 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. Among 48 patients enrolled, one patient withdrew the consent before undergoing the first injection. Therefore the adverse event was assessed in 47 patients.
Eye disorders Conjunctival hemorrhage	8.5% 4/47 • Number of events 11 • Adverse events data was collected during the study perioid, or 1 year.

Additional Information

Ji Eun Lee, Assoicated professor

Pusan National University Hospital

Phone: +82-51-240-7957

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place