Trial to Assess the Efficacy of Neuroprotective Drugs Administered Topically to Prevent or Arrest Diabetic Retinopathy
NCT ID: NCT01726075
Last Updated: 2016-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
450 participants
INTERVENTIONAL
2013-02-28
2015-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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COLIRIOBCN070660
COLIRIOBCN070660 Somatostatin 1mg/mL Eye drops, solution. One drop/eye administered twice a day.
COLIRIOBCN070660
One drop per eye twice a day during 24 months
Placebo
Placebo Eye drops, solution. One drop/eye administered twice a day.
Placebo
One drop per eye twice a day during 24 months
Brimonidine
Brimonidine tartrate 2mg/mL One drop/eye administered twice a day.
Brimonidine
One drop per eye twice a day during 24 months
Interventions
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COLIRIOBCN070660
One drop per eye twice a day during 24 months
Placebo
One drop per eye twice a day during 24 months
Brimonidine
One drop per eye twice a day during 24 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Diabetes duration ≥ 5 years
3. Aged between 45-75 years-old
4. ETDRS level \< 20 (microaneurysms absent) (50% of enrolled patients) Or ETDRS levels 20 or 35 with presence of at least one microaneurysm in Field 2 between the superior and inferior arcades (50% of enrolled patients) in the Study Eye as determined by the Reading Centre.
5. Informed Consent
Exclusion Criteria
2. Other diseases which may induce retinal degeneration (e.g. glaucoma)
3. Subject with a refractive error ≥ ± 5 diopter
4. Inadequate ocular media and/ or pupil dilatation that do not permit good quality fundus photography.
5. Renal failure (creatinine \> 1.4 mg/dl)
6. HbA1C \> 10 % in the previous 6 months and at Screening
7. Subjects taking somatostatin or brimonidine, for any indication, in the previous 3 months
8. Subject has a condition or is in a situation which may put the subject at significant risk, may confound the study results or may interfere significantly with the patient's participation in the study.
9. Pregnancy or nursing
10. Hypersensitivity to the active substances to be tested or to any of the excipients
11. Subject receiving systemic monoamine oxidase (MAO) inhibitor therapy or antidepressants which affect noradrenergic transmission (e.g. tricyclic antidepressants and mianserin)
45 Years
75 Years
ALL
No
Sponsors
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BCN Peptides
INDUSTRY
Responsible Party
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Principal Investigators
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José Cunha-Vaz, Prof.
Role: PRINCIPAL_INVESTIGATOR
Association for Innovation and Biomedical Research on Light and Image
Locations
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Syddansk Universitet (SDU)
Odense, , Denmark
AP - Hopitaux de Paris (AP-HP)
Paris, Paris, France
Universitaet Ulm (UUlm)
Ulm, , Germany
Universita Vita-Salute San Raffaele (USR)
Milan, , Italy
Universita degli Study di Padova(UPadova)
Padua, , Italy
Aibili - Cec
Coimbra, Coimbra District, Portugal
Institut Catala de la Salut - Hospital Universitari Vall d'Hebron (ICS-HUVH)
Barcelona, Barcelona, Spain
Gloucestershire Hospitals NHS Foundation Trust (CHGH)
Cheltenham, Gloucestershire, United Kingdom
Moorfields Eye Hospital NHS Foundation Trust (MEH)
London, London, United Kingdom
Aston University (UAston)Heart of England NHS Foundation Trust
Birmingham, , United Kingdom
The University of Liverpool (UOL)
Liverpool, , United Kingdom
Countries
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References
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Cunha-Vaz J, Ribeiro L, Costa M, Simo R. Diabetic Retinopathy Phenotypes of Progression to Macular Edema: Pooled Analysis From Independent Longitudinal Studies of up to 2 Years' Duration. Invest Ophthalmol Vis Sci. 2017 May 1;58(6):BIO206-BIO210. doi: 10.1167/iovs.17-21780.
Santos AR, Ribeiro L, Bandello F, Lattanzio R, Egan C, Frydkjaer-Olsen U, Garcia-Arumi J, Gibson J, Grauslund J, Harding SP, Lang GE, Massin P, Midena E, Scanlon P, Aldington SJ, Simao S, Schwartz C, Ponsati B, Porta M, Costa MA, Hernandez C, Cunha-Vaz J, Simo R; European Consortium for the Early Treatment of Diabetic Retinopathy (EUROCONDOR). Functional and Structural Findings of Neurodegeneration in Early Stages of Diabetic Retinopathy: Cross-sectional Analyses of Baseline Data of the EUROCONDOR Project. Diabetes. 2017 Sep;66(9):2503-2510. doi: 10.2337/db16-1453. Epub 2017 Jun 29.
Other Identifiers
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2012-001200-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
4C-2011-02
Identifier Type: -
Identifier Source: org_study_id
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