CEC // Clinical Trials Centre

 

Investigator Initiated Studies

 

Diabetic Retinopathy

  1. CORDIS – Characterization of retinal vascular disease in eyes with mild to moderate Nonproliferative diabetic retinopathy in Diabetes type 2, using novel non-invasive imaging methods, in a longitudinal and prospective clinical study with 2 years of duration

ClinicalTrials.gov nº: NCT03696810

Financial support: Portugal 2020 – 02/SAICT/2017 – Project nº 030375

 

  1. RECOGNISED – Retinal and Cognitive Dysfunction in Type 2 Diabetes: Unraveling the Common Pathways and Identification of Patients at Risk of Dementia

ClinicalTrials.gov nº: NCT04281186

Financial support: European Union – H2020-SC1-BHC-01-2019-847749

 

  1. PROGRESS 10 – Progression of Diabetic Retinopathy. Identification of Signs and Surrogate outcomes -10-year follow-up

ClinicalTrials.gov nº: NCT04650165

 

  1. CHART – Characterization of Retinal disease progression in eyes with NPDR in diabetes Type 2 using non-invasive procedures

ClinicalTrials.gov nº: NCT04636307

Financial support: IIR Grant from Bayer

 

  1. RICHARD – Retinal Ischemia characterization in diabetes

ClinicalTrials.gov nº: NCT05112445

Financial support: IIR Grant from Boehringer Ingelheim

 

  1. Exploratory project – Diabetic Retinopathy: from clinical to cellular phenotyping

Financial support: AIBILI

 

  1. PREDICTION – Prediction of Retinal Ischemia in Diabetes

ClinicalTrials.gov nº: NCT05581225

 

Age-Related Macular Degeneration

  1. MACUSTAR – Intermediate AMD: Development of novel clinical endpoints for clinical trials in patients with a regulatory and patient access intention

ClinicalTrials.gov nº: NCT03349801

Financial Support: European Union and EFPIA – Innovative Medicines Initiative 2 Joint Undertaking – Grant Agreement nº 116076

 

  1. AMDMetab – Metabolomics: An Integrative Tool for Investigating the Pathogenesis of Age-related Macular Degeneration

Partner: Massachusetts Eye and Ear Infirmary (MEEI) and the Harvard Medical School, Boston, USA

ClinicalTrials.gov nº: NCT04241536

Financial Support: EURETINA Clinical Research Award

 

Retinal Degenerative Diseases

  1. STAR – Development of a Model for Advanced Screening for Timely Treatment of Age-Related Eye Diseases

 

  1. EYEMARKER – Characterization of potential biomarkers of Eye Disease and Vision Loss

ClinicalTrials.gov nº: NCT02500862

 

Industry Sponsored Clinical Trials

 

Diabetic Macular Edema

    1. A two-year, three-arm, randomized, double-masked, multicentre, phase III study assessing the efficacy and safety of brolucizumab versus aflibercept in adult patients with visual impairment due to diabetic macular edema (KESTREL)

    EudraCT nº: 2017-004742-23

     

    1. A Multicenter, Open-Label Extension Study To Evaluate The Long-Term Safety And Tolerability Of Faricimab In Patients With Diabetic Macular Edema (Rhone-X)

    EudraCT nº: 2020-000402-29

     

    1. A Phase 2 Randomized, Placebo-controlled, Double-masked Proof-of-concept Study to Investigate the Efficacy and Safety of Runcaciguat (BAY 1101042) in Patients With Moderately Severe to Severe Non-proliferative Diabetic Retinopathy (NEON)

    EudraCT nº: 2020-002333-15

     

    Age-Related Macular Degeneration

     

    1. A 52-week multicenter, randomized, double-masked, 2-arm parallel study to compare efficacy, safety and immunogenicity of SOK583A1 to Eylea®, administered intravitreally, in patients with neovascular age-related macular degeneration (Mylight)

    EudraCT nº: 2019-004838-41

     

    Glaucoma

     

    1. Long-Term Surveillance Study of Latanoprost to Monitor Hyperpigmentation changes in the eye in Pediatric Populations (A6111144)

     

    Neurological Disorders

     

    1. A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis (EXPAND)

    EudraCT nº: 2012-003056-36

     

    1. Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis (OPTIMUM)

    EudraCT nº: 2016-004719-10

     

    Oncology

     

    1. A Phase 3 Multicenter, Open-Label, Randomized, Controlled Study of Oral Infigratinib Versus Gemcitabine With Cisplatin in Subjects With Advanced/Metastatic or Inoperable Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations: the PROOF Trial (PROOF)

    EudraCT nº: 2018-004004-19