Randomized, Double-masked, Sham-controlled Phase 4 Study, Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Monotherapy Compared to Aflibercept With Adjunctive Photodynamic Therapy in Patients With Polypoidal Choroidal Vasculopathy
Information source: Association for Innovation and Biomedical Research on Light and Image
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Polypoidal Choroidal Vasculopathy
Intervention: IVT Aflibercept; Verteporfin PDT (Drug); IVT Aflibercept; Sham PDT (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Association for Innovation and Biomedical Research on Light and Image Overall contact: Ana Pedroso, Phone: +351 239 480 131, Email: apedroso@aibili.pt
Summary
The purpose of this study is to compare the efficacy and safety of intravitreal Aflibercept
monotherapy with the efficacy and safety of combined treatment with Aflibercept plus
standard photodynamic therapy (PDT) with Verteporfin in age-related macular degeneration
(AMD) patients with polypoidal choroidal vasculopathy (PCV).
Clinical Details
Official title: A Randomized, Double-masked, Sham-controlled Phase 4 Study of the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Monotherapy Compared to Aflibercept With Adjunctive Photodynamic Therapy in Patients With Polypoidal Choroidal Vasculopathy.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change in Best Corrected Visual Acuity (BCVA)Polyps regression
Secondary outcome: Polyps regression, assessed by Indocyanine Green Angiography (ICGA);Presence of active polyps, assessed by Indocyanine Green Angiography (ICGA); Presence of leakage based on fluorescein angiography (FA) Change in the Subfield Central Retinal Thickness (CRT), assessed by Spectral Domain-Optical Coherence Tomography (SD-OCT); Presence of fluid assessed on Spectral Domain-Optical Coherence Tomography (SD-OCT) at Week 52; Total number of treatments with Aflibercept; Frequency and severity of ocular and non-ocular adverse events over time.
Eligibility
Minimum age: 18 Years.
Maximum age: 90 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Either gender and Age ≥ 50.
- Naïve PCV patients.
- Confirmed diagnosis of symptomatic macular PCV in the study eye.
- Greatest linear dimension of the lesion of < 5400 mm, assessed by ICG angiography.
- BCVA at study entry of 25 to 80 letters (Snellen Equivalent 20/320 to 20/25).
- Lesion size in the study eye at study entry:
- Presence of PCV assessed by the Central Reading Centre based on ICG with active
polyps with or without abnormal vascular network.
- Women must be using effective contraception, be post-menopausal for at least
- months prior to trial entry, or surgically sterile.
- Ability to provide written informed consent.
- Ability to return for all study visits.
Exclusion Criteria:
- Active inflammation or infection in the study eye.
- Uncontrolled intraocular pressure in the study eye.
- Ocular condition in the study eye which may impact vision and confound study outcomes
(e. g. vitreomacular traction, epirretinal membrane with BCVA impact, ocular
inflammation, retinal vascular diseases like diabetic retinopathy or diabetic macular
edema).
- Presence of centromacular scarring or atrophy indicating irreversible BCVA loss.
- Prior treatment of the study eye with anti-VEGF therapy or systemic use of anti-VEGF
products within 3 months prior to the study entry.
- Previous vitrectomy, macular laser treatment, PDT, or intraocular steroids in the
study eye.
Locations and Contacts
Ana Pedroso, Phone: +351 239 480 131, Email: apedroso@aibili.pt Additional Information
Starting date: September 2015
Last updated: July 10, 2015
|