Services / Activities

- Certified Clinical Trial Centres with harmonized procedures (SOPs), quality control and qualified personnel

 

- Feasibility assessment for centre participation and recruitment (performed at short notice)

 

- Help in achieving recruitment rate by contacting directly and regularly the participating centres

 

- Scientific advice including contributions to clinical trial design

 

- Certification and training of technical personnel

 

- Facilitation of administrative setup of contracts with Clinical Trial Centres

 

- Subspecialty clinical trial research networks

 

- Access to the EVICR.net Reading Centre Network



Alliances and Partnerships


EVICR.net is an ECRIN-ERIC Affiliate Partner as a disease oriented network in Ophthalmology.

ECRIN is the European Clinical Research Infrastructure Network and supports the conduct of independent, multinational clinical trials by managing and supporting clinical trials across borders, connecting networks, and advising and implementing policy, competitiveness and integration in European clinical research.
ECRIN Affiliate Partners are multinational disease-oriented networks who wish to maintain close contact and participate in collaborative projects and EVICR.net will jointly support multinational clinical studies in ophthalmology.


EVICR.net serves as a resource to ECRIN-ERIC in the area of vision and ophthalmology clinical research, particularly providing scientific and medical expertise, access to patients and investigation capacity in ophthalmology.

 

 

Ongoing Services

 

1. Investigator Initiated Research

PROTOCOL nš: ECR-RET-2011-03 (EUROCONDOR)
TITLE: Neurodegeneration as an early event in the pathogenesis of Diabetic Retinopathy: A multicentric, prospective, phase II-III, double-blind randomized controlled trial to assess the efficacy of neuroprotective drugs administered topically to prevent or arrest Diabetic Retinopathy
PURPOSE: To assess whether neuroprotective drugs administered topically (somatostatin and brimonidine) are able to prevent or arrest the development and progression of neurodegenerative changes.

EU funded  FP7- HEALTH 2011 project: 278040-2

EudraCT Nš: 2012-001200-38

ClinicalTrials.gov Identifier: NCT01726075

 

PROTOCOL nš: ECR-GLC-2012-04 (STRONG)
TITLE: Early onset of Neovascular Glaucoma

PURPOSE: To study the natural course of the disease, to determine risk factors for the occurrence of neovascular glaucoma and to identify biomarkers that better characterize the course of the disease. At the same time to test the efficacy of aganirsen for the treatment of neovascular glaucoma in about three hundred patients in 35 clinical centres across Europe.

EU funded FP7- HEALTH 2012 project: 305321

 


PROTOCOL nš: ECR-RET-2013-05 (PROTEUS)
TITLE: Prospective, randomized, multicenter, open label, phase II/III study to assess efficacy and safety of ranibizumab 0.5 mg intravitreal injections plus panretinal photocoagulation (PRP) versus and PRP in monotherapy in the treatment of patients with high risk proliferative diabetic retinopathy.
PURPOSE: To compare efficacy and evaluate safety of intravitreal (ITV) injection of ranibizumab (0.5 mg) plus PRP versus PRP alone in the regression of retinal neovascularization (NV) in eyes with high-risk proliferative diabetic retinopathy (HR-PDR).

 


PROTOCOL nš: ECR-RET-2014-07 (ARTES)
TITLE: A Collaborative Retrospective Trial on the Efficacy and Safety of intravitreal dexamethasone implant (Ozurdex) in patients with Diabetic Macular Edema (DME). THE EUROPEAN DME REGISTRAR STUDY
PURPOSE: To review  the safety and efficacy of injections with Ozurdex  (700 μg dexamethasone) in clinical practice management of patients with DME.


PROTOCOL nš: ECR-ADM-2015-09 (ATLANTIC)
TITLE: A randomized, double-masked, sham-controlled phase 4 study of the efficacy, safety and tolerability of intravitreal aflibercept monotherapy compared to aflibercept with adjunctive photodynamic therapy in patients with plypoidal choroidal vasculopathy.
PURPOSE: 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.

         

PROTOCOL nš: ECR-AS-2017-12 (REDCAKE)

TITLE: Retrospective Digital Computer Analysis of Keratoconus Evolution.

PURPOSE: To create a database of keratoconic eyes with two or more corneal topographies/tomographies, at least 5 months apart. The patient cohort should have a wide variety of ages and all degrees of disease severity. This will assist in building a system to estimate the risk of keratoconus progression based on patient demographic and corneal data first measured..

ClinicalTrials.gov Identifier: NCT03235856


PROTOCOL nš: ECR-AMD-2017-13 (MACUSTAR)

TITLE: Development of novel clinical endpoints for interventional clinical trials with a regulatory and patient access intention in patients with intermediate age-related macular degeneration (AMD).

PURPOSE: To develop novel clinical endpoints for CTs with a regulatory and patient access intention in patients with iAMD.

ClinicalTrials.gov Identifier: TBD

EudraCT Nš: TBD

EU funded IMI2 project: 116076


 

 2. Industry-Driven Clinical Trials


PROTOCOL nš: IRISS
TITLE: An open label, registry study of the safety of ILUVIENŪ (fluocinolone acetonide 190 micrograms intravitreal implant in applicator)
PURPOSE: The study will assess the safety and usage in patients treated with ILUVIEN.

 


3. Certification for Refraction and Visual Acuity

3.1 Specific Agreements are celebrated according to the Sponsor request and study specificity.


 


 

 

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