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

NCT ID: NCT02495181

Last Updated: 2020-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-23
• Study Completion Date: 2019-12-17

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.

Conditions

Polypoidal Choroidal Vasculopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Aflibercept Monotherapy

IVT Aflibercept 2 mg + Sham PDT

Group Type: SHAM_COMPARATOR

Intravitreal Aflibercept

Intervention Type: DRUG

Aflibercept + verteporfin PDT

IVT Aflibercept 2 mg + Verteporfin PDT

Group Type: ACTIVE_COMPARATOR

Intravitreal Aflibercept

Intervention Type: DRUG

Interventions

Intravitreal Aflibercept

Intervention Type: DRUG

Other Intervention Names

standard photodynamic therapy (PDT)

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Vision Institute Clinical Research Network

NETWORK

Sponsor Role: collaborator

Association for Innovation and Biomedical Research on Light and Image

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rufino Silva, PhD

Role: PRINCIPAL_INVESTIGATOR

Association for Innovation and Biomedical Research on Light and Image

Locations

Hospital de Braga

Braga, , Portugal

AIBILI - Centro de Ensaios Clínicos

Coimbra, , Portugal

Espaço Médico de Coimbra

Coimbra, , Portugal

Centro Hospitalar de Leiria

Leiria, , Portugal

IRL - Instituto de Retina e Diabetes de Lisboa

Lisbon, , Portugal

Centro Hospitgalar de Lisboa Norte, EPE - Hospital de Santa Maria

Lisbon, , Portugal

Instituto de Oftalmologia Dr. Gama Pinto

Lisbon, , Portugal

Centro Hospitalar do Porto- Hospital de Santo António

Porto, , Portugal

Centro Hospitalar de São João, EPE - Serviço de Oftalmologia

Porto, , Portugal

Bellvitge University Hospital

Barcelona, , Spain

Instituto de Microcirugia Ocular

Barcelona, , Spain

Vall d'Hebron Hospital

Barcelona, , Spain

Hospital Insular de Gran Canaria

Las Palmas, , Spain

Countries

Portugal; Spain

References

Silva R, Arias L, Nunes S, Farinha C, Coimbra R, Marques JP, Cachulo ML, Figueira J, Barreto P, Madeira MH, Pires I, Sousa JC, Distefano L, Rosa P, Carneiro A, Vaz-Pereira S, Meireles A, Cabrera F, Bures A, Mendonca L, Fernandez-Vega-Sanz A, Barrao S, Koh A, Cheung CMG, Cunha-Vaz JG, Murta J; EVICR.net ATLANTIC Study Group. Efficacy and Safety of Intravitreal Aflibercept Treat and Extend for Polypoidal Choroidal Vasculopathy in the ATLANTIC Study: A Randomized Clinical Trial. Ophthalmologica. 2022;245(1):80-90. doi: 10.1159/000518235. Epub 2021 Jul 13.

Reference Type: DERIVED

PMID: 34348351 (View on PubMed)

Marques JP, Farinha C, Costa MA, Ferrao A, Nunes S, Silva R. Protocol for a randomised, double-masked, sham-controlled phase 4 study on the efficacy, safety and tolerability of intravitreal aflibercept monotherapy compared with aflibercept with adjunctive photodynamic therapy in polypoidal choroidal vasculopathy: the ATLANTIC study. BMJ Open. 2017 Aug 28;7(8):e015785. doi: 10.1136/bmjopen-2016-015785.

Reference Type: DERIVED

PMID: 28851779 (View on PubMed)

Other Identifiers

ECR-AMD-2015-09

Identifier Type: -

Identifier Source: org_study_id