Effect of Intravitreal VEGF-Trap Eye on Polypoidal Choroidal Vasculopathy (VAULT)
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ClinicalTrials.gov Identifier: NCT01950741 |
Recruitment Status :
Completed
First Posted : September 25, 2013
Results First Posted : April 29, 2016
Last Update Posted : April 29, 2016
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Condition or disease | Intervention/treatment | Phase |
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Exudative Age-related Macular Degeneration Polypoidal Choroidal Vasculopathy | Drug: aflibercept | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 48 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Single Arm, Single Dose Study to Evaluate the Effect of Intravitreal Injection of VEGF-Trap Eye on Polypoidal Choroidal Vasculopathy |
Study Start Date : | September 2013 |
Actual Primary Completion Date : | May 2015 |
Actual Study Completion Date : | August 2015 |

Arm | Intervention/treatment |
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Experimental: 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).
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Drug: aflibercept
Aflibercept is injected intravitreally though the pars plana using 30G needle-attached syringe.
Other Name: Eyelea, VEGF Trap-Eye |
- Percentage of Patients Lose Visual Acuity Less Than 15 Letters [ Time Frame: 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.
- Change in Visual Acuity From Baseline to 12 Months [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts 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)
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Presence of signs of recent activity of PCV
- Visual acuity between 20/40 and 20/320
- Active leakage in fluorescein angiography
- Presence of any fluid in OCT(optical coherence tomography)-intraretinal, subretinal, sub-retinal pigment epithelial
Exclusion Criteria:
- Extramacular PCV
- Subretinal hemorrhage or other retinal lesions blocking angiographic characteristics in more than 50% area of PCV lesion.
- Previous treatment of intravitreal injections (anti-VEGF, steroid or other agents)
- Previous treatment of photodynamic therapy
- Previous ocular surgery except cataract surgery before 3 or more months
- Presence of exudative AMD in the other eyes requiring anti-VEGF treatment (Intravitreal bevacizumab was reported to affect the other eye.)
- Presence of other ocular diseases which may affect visual acuity (glaucoma, cataract with opacity involving visual axis, etc)
- Presence of uncontrolled systemic disease (diabetes mellitus, hypertension, ischemic heart disease, cerebral infarction, etc)
- Patients who cannot understand or conform to the study protocol.
- Patients who refuse to agree to the informed consent.
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Patients with contraindication to aflibercept
- Ocular or periocular infection
- Active severe intraocular inflammation
- Known hypersensitivity to aflibercept or to any of the excipients

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01950741
Korea, Republic of | |
Busan Paik Hospital | |
Busanjin-gu, Busan, Korea, Republic of, 614-735 | |
Haeundae Paik Hospital | |
Haeundae, Busan, Korea, Republic of, 612-030 | |
Gospel Hospital | |
Seo-gu, Busan, Korea, Republic of, 602-702 | |
Pusan National University Hospital | |
Seo-gu, Busan, Korea, Republic of, 602-739 | |
Keimyung University Dongsan Medical Center | |
Jung-gu, Daegu, Korea, Republic of | |
Kyungpook National University Hospital | |
Jung-gu, Daegu, Korea, Republic of | |
Yeungnam University Medical Center | |
Nam-gu, Daegu, Korea, Republic of, 705-717 | |
Gyeongsang National University Hospital | |
Jinju, Gyeongsangnam-do, Korea, Republic of, 660-702 |
Study Director: | Jae Pil Shin, MD, PhD | Kyungbuk National University Hospital |
Responsible Party: | Ji Eun Lee, Associate professor, Pusan National University Hospital |
ClinicalTrials.gov Identifier: | NCT01950741 |
Other Study ID Numbers: |
D-1304-013-014 |
First Posted: | September 25, 2013 Key Record Dates |
Results First Posted: | April 29, 2016 |
Last Update Posted: | April 29, 2016 |
Last Verified: | March 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Macular Degeneration Vascular Diseases Retinal Degeneration |
Retinal Diseases Eye Diseases Cardiovascular Diseases |