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

Polypoidal Choroidal Vasculopathy Clinical Trial

— ATLANTIC  

Official title:

A Randomized, Double-masked, Sham-controlled Phase 4 Study of the Efficacy, Safety, and Tolerability of IV Aflibercept Monotherapy Compared to Aflibercept With Adjunctive Photodynamic Therapy in Patients With PCV.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02495181
• Other study ID #: ECR-AMD-2015-09
• Status: Completed
• Phase: Phase 4
• Start date: November 23, 2015
• Est. completion date: December 17, 2019

Study information

• Verified date: February 2019
• Source: Association for Innovation and Biomedical Research on Light and Image
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 17, 2019
• Est. primary completion date: August 22, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Polypoidal Choroidal Vasculopathy
• Vascular Diseases

Intervention

Drug:
• Intravitreal Aflibercept

Locations

Country	Name	City	State
Portugal	Hospital de Braga	Braga
Portugal	AIBILI - Centro de Ensaios Clínicos	Coimbra
Portugal	Espaço Médico de Coimbra	Coimbra
Portugal	Centro Hospitalar de Leiria	Leiria
Portugal	Centro Hospitgalar de Lisboa Norte, EPE - Hospital de Santa Maria	Lisboa
Portugal	Instituto de Oftalmologia Dr. Gama Pinto	Lisboa
Portugal	IRL - Instituto de Retina e Diabetes de Lisboa	Lisboa
Portugal	Centro Hospitalar de São João, EPE - Serviço de Oftalmologia	Porto
Portugal	Centro Hospitalar do Porto- Hospital de Santo António	Porto
Spain	Bellvitge University Hospital	Barcelona
Spain	Instituto de Microcirugia Ocular	Barcelona
Spain	Vall d'Hebron Hospital	Barcelona
Spain	Hospital Insular de Gran Canaria	Las Palmas

Sponsors (2)

Lead Sponsor	Collaborator
Association for Innovation and Biomedical Research on Light and Image	European Vision Institute Clinical Research Network

Countries where clinical trial is conducted

Portugal,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Best Corrected Visual Acuity (BCVA)	Unit of Measure: [Letters]	from Baseline (Week 0) to Week 52.
Primary	Polyps regression	Unit of Measure: [Yes, No]	from Baseline (W0) to Week 52.
Secondary	Polyps regression, assessed by Indocyanine Green Angiography (ICGA);	Unit of Measure: [Yes, No]	from Baseline (W0) to Week 16
Secondary	Presence of active polyps, assessed by Indocyanine Green Angiography (ICGA);	Unit of Measure: [Yes, No]	from Baseline (W0) to Week 52
Secondary	Presence of leakage based on fluorescein angiography (FA)	Unit of Measure: [Yes, No]	from Baseline (W0) to Week 52
Secondary	Change in the Subfield Central Retinal Thickness (CRT), assessed by Spectral Domain-Optical Coherence Tomography (SD-OCT);	Unit of Measure: [µm]	from Baseline (W0) to Week 52
Secondary	Presence of fluid assessed on Spectral Domain-Optical Coherence Tomography (SD-OCT) at Week 52;	Unit of Measure: [Yes, No]	from Baseline (W0) to Week 52
Secondary	Total number of treatments with Aflibercept;	Unit of Measure: [#]	from Baseline (W0) to Week 52
Secondary	Frequency and severity of ocular and non-ocular adverse events over time.	Unit of Measure: [Mild, Moderate, Severe]	from Baseline (W0) to Week 52