Clinical trial NCT02495181: 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
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Polypoidal Choroidal Vasculopathy
Lead sponsor: Association for Innovation and Biomedical Research on Light and Image
Sponsor class: OTHER
Collaborators: name: European Vision Institute Clinical Research Network
First posted: 2015-07-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Best Corrected Visual Acuity (BCVA)
timeFrame: from Baseline (Week 0) to Week 52.
measure: Polyps regression
timeFrame: from Baseline (W0) to Week 52.
Secondary outcomes:
measure: Polyps regression, assessed by Indocyanine Green Angiography (ICGA);
timeFrame: from Baseline (W0) to Week 16
measure: Presence of active polyps, assessed by Indocyanine Green Angiography (ICGA);
timeFrame: from Baseline (W0) to Week 52
measure: Presence of leakage based on fluorescein angiography (FA)
timeFrame: from Baseline (W0) to Week 52
measure: Change in the Subfield Central Retinal Thickness (CRT), assessed by Spectral Domain-Optical Coherence Tomography (SD-OCT);
timeFrame: from Baseline (W0) to Week 52
measure: Presence of fluid assessed on Spectral Domain-Optical Coherence Tomography (SD-OCT) at Week 52;
timeFrame: from Baseline (W0) to Week 52
measure: Total number of treatments with Aflibercept;
timeFrame: from Baseline (W0) to Week 52
measure: Frequency and severity of ocular and non-ocular adverse events over time.
timeFrame: from Baseline (W0) to Week 52
Other outcomes:
Locations:
city: Braga
country: Portugal
facility: Hospital de Braga
city: Coimbra
country: Portugal
facility: AIBILI - Centro de Ensaios Clínicos
city: Coimbra
country: Portugal
facility: Espaço Médico de Coimbra
city: Leiria
country: Portugal
facility: Centro Hospitalar de Leiria
city: Lisboa
country: Portugal
facility: IRL - Instituto de Retina e Diabetes de Lisboa
city: Lisboa
country: Portugal
facility: Centro Hospitgalar de Lisboa Norte, EPE - Hospital de Santa Maria
city: Lisboa
country: Portugal
facility: Instituto de Oftalmologia Dr. Gama Pinto
city: Porto
country: Portugal
facility: Centro Hospitalar do Porto- Hospital de Santo António
city: Porto
country: Portugal
facility: Centro Hospitalar de São João, EPE - Serviço de Oftalmologia
city: Barcelona
country: Spain
facility: Bellvitge University Hospital
city: Barcelona
country: Spain
facility: Instituto de Microcirugia Ocular
city: Barcelona
country: Spain
facility: Vall d'Hebron Hospital
city: Las Palmas
country: Spain
facility: Hospital Insular de Gran Canaria
Study officials:
affiliation: Association for Innovation and Biomedical Research on Light and Image
name: Rufino Silva, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.