Trial to Assess the Efficacy of Neuroprotective Drugs Administered Topically to Prevent or Arrest Diabetic Retinopathy
Information source: BCN Peptides
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetic Retinopathy
Intervention: COLIRIOBCN070660 (Drug); Placebo (Drug); Brimonidine (Drug)
Phase: Phase 2/Phase 3
Status: Active, not recruiting
Sponsored by: BCN Peptides Official(s) and/or principal investigator(s):
José Cunha-Vaz, Prof., Principal Investigator, Affiliation: Association for Innovation and Biomedical Research on Light and Image
Summary
To assess whether neuroprotective drugs administered topically (somatostatin and
brimonidine) are able to prevent or arrest the development and progression of
neurodegenerative changes
Clinical Details
Official title: Neurodegeneration as Early Event in Pathogenesis of Diabetic Retinopathy:Multicentric, Prospective, Ph. II-III,Random.Controlled Trial to Assess Efficacy of Neuroprotective Drugs Administered Topically to Prevent/Arrest Diabetic Retinopathy
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Changes in the Implicit Time assessed by mfERG (IT-mfERG) at month 6, 12, 18 and 24
Secondary outcome: Retinal Nerve Fiber Layer (RNFL) assessed by Spectral Domain Optical Coherence Tomography (SD-OCT) at month 0Retinal Nerve Fiber Layer (RNFL) assessed by SD-OCT at month 6 Retinal Nerve Fiber Layer (RNFL) assessed by SD-OCT at month 12 Retinal Nerve Fiber Layer (RNFL) assessed by SD-OCT at month 18 Retinal Nerve Fiber Layer (RNFL) assessed by SD-OCT at month 24 Ganglion Cell Layer (GCL) assessed by SD-OCT at month 0 Ganglion Cell Layer (GCL) assessed by SD-OCT at month 6 Ganglion Cell Layer (GCL) assessed by SD-OCT at month 12 Ganglion Cell Layer (GCL) assessed by SD-OCT at month 18 Ganglion Cell Layer (GCL) assessed by SD-OCT at month 24 Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at baseline Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at month 6 Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at month 12 Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at month 18 Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at month 24 Retinal thickness assessed by SD-OCT at month 0 Retinal thickness assessed by SD-OCT at month 6 Retinal thickness assessed by SD-OCT at month 12 Retinal thickness assessed by SD-OCT at month 18 Retinal thickness assessed by SD-OCT at month 24 Central retinal thickness assessed by SD-OCT at month 0 Central retinal thickness assessed by SD-OCT at month 6 Central retinal thickness assessed by SD-OCT at month 12 Central retinal thickness assessed by SD-OCT at month 18 Central retinal thickness assessed by SD-OCT at month 24 Diabetic Retinopathy (DR) severity assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) scale CFP - 30º/35º-7 fields at baseline DR severity assessed by ETDRS scale CFP - 30º/35º-7 fields at month 24
Detailed description:
To assess whether neuroprotective drugs administered topically (somatostatin and
brimonidine) are able to prevent or arrest the development and progression of
neurodegenerative changes related to diabetic retinopathy.
Eligibility
Minimum age: 45 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Patients with type 2 diabetes mellitus
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:
1. Previous laser photocoagulation
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)
Locations and Contacts
Syddansk Universitet (SDU), Odense, Denmark
AP - Hopitaux de Paris (AP-HP), Paris 75010, France
Universitaet Ulm (UUlm), Ulm 89081, Germany
Universita Vita-Salute San Raffaele (USR), Milano 20132, Italy
Universita degli Study di Padova(UPadova), Padova 35128, Italy
Aibili - Cec, Coimbra 3000-548, Portugal
Institut Catala de la Salut - Hospital Universitari Vall d'Hebron (ICS-HUVH), Barcelona 08035, Spain
Aston University (UAston)Heart of England NHS Foundation Trust, Birmingham, United Kingdom
The University of Liverpool (UOL), Liverpool, United Kingdom
Moorfields Eye Hospital NHS Foundation Trust (MEH), London EC1V2PD, United Kingdom
Gloucestershire Hospitals NHS Foundation Trust (CHGH), Cheltenham, Gloucestershire, United Kingdom
Additional Information
Starting date: February 2013
Last updated: January 26, 2015
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