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 – RECOGNISED

ClinicalTrials.gov nº: NCT04281186

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

 

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

 

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 phase III, multicentre, randomized, double-masked, active comparator-controlled study to evaluate the efficacy and safety of RO6867461 in patients with diabetic macular edema (RHINE)

EudraCT nº: 2017-005105-12

 

  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 randomized, double-masked, placebo-controlled exploratory study to evaluate safety, tolerability, pharmacodynamics and pharmacokinetics of orally administered BI 1467335 for 12 weeks with a 12 week follow up period in patients with non-proliferative diabetic retinopathy without center-involved diabetic macular edema (ROBIN Study)

EudraCT nº: 2016-002971-91

 

  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

 

 

Age-Related Macular Degeneration

  1. An open-label, randomized, active-controlled, parallel-group, Phase-3b study of the efficacy, safety, and tolerability of 2 mg aflibercept administered by intravitreal injections using two different treatment regimens to subjects with neovascular age-related macular degeneration (nAMD) (AZURE)

EudraCT nº: 2012-003763-22

 

  1. A Multicenter, Double Masked, Randomized, Dose-Ranging Trial to Evaluate the Efficacy and Safety of Conbercept Intravitreal Injection in Subjects with Neovascular Age-Related Macular Degeneration (PANDA)

EudraCT nº: 2017-004825-34

 

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. Open-label, single-arm trial to evaluate antitumor activity, safety, and pharmacokinetics of SAR408701 used in combination with ramucirumab in metastatic, nonsquamous, non–small-cell lung cancer (NSQ NSCLC) patients with CEACAM5-positive tumors, previously treated with platinum-based chemotherapy and an immune checkpoint inhibitor

EudraCT nº: 2019-003914-15