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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 (ATLANTIC)

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ClinicalTrials.gov Identifier: NCT02495181
Recruitment Status : Recruiting
First Posted : July 13, 2015
Last Update Posted : July 23, 2018
Sponsor:
Collaborator:
European Vision Institute Clinical Research Network
Information provided by (Responsible Party):
Association for Innovation and Biomedical Research on Light and Image

March 23, 2015
July 13, 2015
July 23, 2018
January 2016
November 2017   (Final data collection date for primary outcome measure)
  • Change in Best Corrected Visual Acuity (BCVA) [ Time Frame: from Baseline (Week 0) to Week 52. ]
    Unit of Measure: [Letters]
  • Polyps regression [ Time Frame: from Baseline (W0) to Week 52. ]
    Unit of Measure: [Yes, No]
Same as current
Complete list of historical versions of study NCT02495181 on ClinicalTrials.gov Archive Site
  • Polyps regression, assessed by Indocyanine Green Angiography (ICGA); [ Time Frame: from Baseline (W0) to Week 16 ]
    Unit of Measure: [Yes, No]
  • Presence of active polyps, assessed by Indocyanine Green Angiography (ICGA); [ Time Frame: from Baseline (W0) to Week 52 ]
    Unit of Measure: [Yes, No]
  • Presence of leakage based on fluorescein angiography (FA) [ Time Frame: 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); [ Time Frame: from Baseline (W0) to Week 52 ]
    Unit of Measure: [µm]
  • Presence of fluid assessed on Spectral Domain-Optical Coherence Tomography (SD-OCT) at Week 52; [ Time Frame: from Baseline (W0) to Week 52 ]
    Unit of Measure: [Yes, No]
  • Total number of treatments with Aflibercept; [ Time Frame: from Baseline (W0) to Week 52 ]
    Unit of Measure: [#]
  • Frequency and severity of ocular and non-ocular adverse events over time. [ Time Frame: from Baseline (W0) to Week 52 ]
    Unit of Measure: [Mild, Moderate, Severe]
Same as current
Not Provided
Not Provided
 
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
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.
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).
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Polypoidal Choroidal Vasculopathy
  • Drug: IVT Aflibercept; Verteporfin PDT
  • Drug: IVT Aflibercept; Sham PDT
  • Sham Comparator: Aflibercept + Verteporfin PDT
    - IVT Aflibercept 2 mg on a Treat & Extend Regimen + Verteporfin PDT
    Intervention: Drug: IVT Aflibercept; Verteporfin PDT
  • Sham Comparator: Aflibercept + Sham PDT
    IVT Aflibercept 2 mg on a Treat & Extend Regimen + Sham PDT
    Intervention: Drug: IVT Aflibercept; Sham PDT
Marques JP, Farinha C, Costa MÂ, Ferrão Â, 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
Same as current
March 2020
November 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 90 Years   (Adult, Older Adult)
No
Contact: Catarina Gomes +351 239 480 131 cmgomes@aibili.pt
Contact: Liliana Carvalho +351 239 480 112 lcarvalho@aibili.pt
Portugal,   Spain
 
 
NCT02495181
ECR-AMD-2015-09
No
Not Provided
Not Provided
Association for Innovation and Biomedical Research on Light and Image
Association for Innovation and Biomedical Research on Light and Image
European Vision Institute Clinical Research Network
Principal Investigator: Rufino Silva, PhD Association for Innovation and Biomedical Research on Light and Image
Association for Innovation and Biomedical Research on Light and Image
July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP