Premium
Neurodegeneration as an early event in the pathogenesis of Diabetic Retinopathy: A multicentric, prospective, phase II‐III, randomised controlled trial to assess the efficacy of neuroprotective drugs administered topically to prevent or arrest Diabetic Retinopathy. EUROCONDOR – EU FP7 Project
Author(s) -
CUNHAVAZ J
Publication year - 2012
Publication title -
acta ophthalmologica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.534
H-Index - 87
eISSN - 1755-3768
pISSN - 1755-375X
DOI - 10.1111/j.1755-3768.2012.2825.x
Subject(s) - medicine , brimonidine , neuroprotection , diabetic retinopathy , neurodegeneration , ophthalmology , nerve fiber layer , retinal , fundus (uterus) , fundus photography , clinical trial , diabetes mellitus , pharmacology , glaucoma , disease , endocrinology , fluorescein angiography
Purpose To assess whether neuroprotective drugs administered topically (somatostatin and brimonidine) are able to prevent or arrest neurodegeneration as well as the development and progression of Diabetic Retinopathy (DR) in its early stages. Methods Primary: 1) To assess whether somatostatin, administered topically, is able to prevent or arrest the development and progression of neurodegenerative changes. 2) To assess whether, brimonidine, administered topically, is able to prevent or arrest the development and progression of neurodegenerative changes. Results Primary: Changes in the Implicit Time assessed by mfERG (IT‐mfERG). Secondary: 1) Neurodegenerative variables: Retinal Nerve Fiber Layer (RNFL); Ganglion Cell Layer (GCL) and central retinal thickness assessed by SD‐OCT. 2) Microaneurysm turnover assessed by Colour Fundus Photography; DR severity. 3) Other variables: BCVA; Visual Fields; Visual‐related Quality of Life; Need for rescue treatment. Conclusion Clinical Trial Population Type II diabetic patients; ETDRS levels <20 (50%) or ≤35 (50%). 450 patients to be enrolled in 11 or more clinical centres in Europe (41 patients per centre).