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

Phase 4

Completed

• Conditions: Polypoidal Choroidal Vasculopathy
• Interventions: Drug: Intravitreal Aflibercept

• Registration Number: NCT02495181
• Lead Sponsor: Association for Innovation and Biomedical Research on Light and Image

Brief 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).

Detailed Description

To compare the efficacy and safety of intravitreal Aflibercept monotherapy with the efficacy and safety of combined treatment with Aflibercept associated with standard photodynamic therapy (PDT) with Verteporfin in age-related macular degeneration (AMD) patients with polypoidal choroidal vasculopathy (PCV) in a proof concept study and to identify genetic biomarkers for the diagnosis and treatment response of PCV in Caucasians.

Study Timeline

• Study First Submitted: 2015-03-23
• Study First Submitted QC: 2015-07-10
• Study First Posted: 2015-07-13
• Study Start: 2015-11-23
• Primary Completion: 2017-08-22
• Status Verified: 2019-02
• Study Completion: 2019-12-17
• Last Update Submitted: 2020-01-08
• Last Update Posted: 2020-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aflibercept Monotherapy	Intravitreal Aflibercept	IVT Aflibercept 2 mg + Sham PDT
Aflibercept + verteporfin PDT	Intravitreal Aflibercept	IVT Aflibercept 2 mg + Verteporfin PDT

Primary Outcome Measures

Name	Time	Method
Change in Best Corrected Visual Acuity (BCVA)	from Baseline (Week 0) to Week 52.	Unit of Measure: \[Letters\]
Polyps regression	from Baseline (W0) to Week 52.	Unit of Measure: \[Yes, No\]

Secondary Outcome Measures

Name	Time	Method
Polyps regression, assessed by Indocyanine Green Angiography (ICGA);	from Baseline (W0) to Week 16	Unit of Measure: \[Yes, No\]
Presence of active polyps, assessed by Indocyanine Green Angiography (ICGA);	from Baseline (W0) to Week 52	Unit of Measure: \[Yes, No\]
Presence of fluid assessed on Spectral Domain-Optical Coherence Tomography (SD-OCT) at Week 52;	from Baseline (W0) to Week 52	Unit of Measure: \[Yes, No\]
Frequency and severity of ocular and non-ocular adverse events over time.	from Baseline (W0) to Week 52	Unit of Measure: \[Mild, Moderate, Severe\]
Presence of leakage based on fluorescein angiography (FA)	from Baseline (W0) to Week 52	Unit of Measure: \[Yes, No\]
Change in the Subfield Central Retinal Thickness (CRT), assessed by Spectral Domain-Optical Coherence Tomography (SD-OCT);	from Baseline (W0) to Week 52	Unit of Measure: \[µm\]
Total number of treatments with Aflibercept;	from Baseline (W0) to Week 52	Unit of Measure: \[#\]

Trial Locations

Locations (13)

Hospital de Braga; 🇵🇹 Braga, Portugal

Centro Hospitgalar de Lisboa Norte, EPE - Hospital de Santa Maria; 🇵🇹 Lisboa, Portugal

Instituto de Microcirugia Ocular; 🇪🇸 Barcelona, Spain

Bellvitge University Hospital; 🇪🇸 Barcelona, Spain

Hospital Insular de Gran Canaria; 🇪🇸 Las Palmas, Spain

Espaço Médico de Coimbra; 🇵🇹 Coimbra, Portugal

Centro Hospitalar de Leiria; 🇵🇹 Leiria, Portugal

Centro Hospitalar do Porto- Hospital de Santo António; 🇵🇹 Porto, Portugal

AIBILI - Centro de Ensaios Clínicos; 🇵🇹 Coimbra, Portugal

IRL - Instituto de Retina e Diabetes de Lisboa; 🇵🇹 Lisboa, Portugal

Instituto de Oftalmologia Dr. Gama Pinto; 🇵🇹 Lisboa, Portugal

Centro Hospitalar de São João, EPE - Serviço de Oftalmologia; 🇵🇹 Porto, Portugal

Vall d'Hebron Hospital; 🇪🇸 Barcelona, Spain