Diabetic Retinopathy
Conditions
Keywords
diabetic retinopathy
Brief summary
To assess whether neuroprotective drugs administered topically (somatostatin and brimonidine) are able to prevent or arrest the development and progression of neurodegenerative changes
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.
Interventions
DRUGCOLIRIOBCN070660
One drop per eye twice a day during 24 months
DRUGPlacebo
One drop per eye twice a day during 24 months
DRUGBrimonidine
One drop per eye twice a day during 24 months
Sponsors
BCN Peptides
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the Implicit Time assessed by mfERG (IT-mfERG) at month 6, 12, 18 and 24 | month 24 |
Secondary
| Measure | Time frame |
|---|---|
| Central retinal thickness assessed by SD-OCT at month 6 | month 6 |
| Ganglion Cell Layer (GCL) assessed by SD-OCT at month 0 | month 0 |
| Ganglion Cell Layer (GCL) assessed by SD-OCT at month 6 | month 6 |
| Ganglion Cell Layer (GCL) assessed by SD-OCT at month 12 | month 12 |
| Ganglion Cell Layer (GCL) assessed by SD-OCT at month 18 | month 18 |
| Ganglion Cell Layer (GCL) assessed by SD-OCT at month 24 | month 24 |
| Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at baseline | baseline |
| Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at month 6 | month 6 |
| Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at month 12 | month 12 |
| Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at month 18 | month 18 |
| Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at month 24 | month 24 |
| Retinal thickness assessed by SD-OCT at month 0 | month 0 |
| Retinal thickness assessed by SD-OCT at month 6 | month 6 |
| Retinal thickness assessed by SD-OCT at month 12 | month 12 |
| Retinal thickness assessed by SD-OCT at month 18 | month 18 |
| Retinal thickness assessed by SD-OCT at month 24 | month 24 |
| Central retinal thickness assessed by SD-OCT at month 0 | month 0 |
| Central retinal thickness assessed by SD-OCT at month 12 | month 12 |
| Central retinal thickness assessed by SD-OCT at month 18 | month 18 |
| Central retinal thickness assessed by SD-OCT at month 24 | month 24 |
| Diabetic Retinopathy (DR) severity assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) scale CFP - 30º/35º-7 fields at baseline | baseline |
| DR severity assessed by ETDRS scale CFP - 30º/35º-7 fields at month 24 | month 24 |
| Retinal Nerve Fiber Layer (RNFL) assessed by Spectral Domain Optical Coherence Tomography (SD-OCT) at month 0 | month 0 |
| Retinal Nerve Fiber Layer (RNFL) assessed by SD-OCT at month 6 | month 6 |
| Retinal Nerve Fiber Layer (RNFL) assessed by SD-OCT at month 12 | month 12 |
| Retinal Nerve Fiber Layer (RNFL) assessed by SD-OCT at month 18 | month 18 |
| Retinal Nerve Fiber Layer (RNFL) assessed by SD-OCT at month 24 | month 24 |
Other
| Measure | Time frame |
|---|---|
| Adverse Events assessed by inquiry at month 3 | month 3 |
| Adverse Events assessed by inquiry at month 6 | month 6 |
| Adverse Events assessed by inquiry at month 12 | month 12 |
| Adverse Events assessed by inquiry at month 18 | month 18 |
| Best Corrected Visual Acuity (BCVA) assessed by ETDRS scale at month 0 | month 0 |
| BCVA assessed by ETDRS scale at month 6 | month 6 |
| BCVA assessed by ETDRS scale at month 12 | month 12 |
| BCVA assessed by ETDRS scale at month 18 | month 18 |
| BCVA assessed by ETDRS scale at month 24 | month 24 |
| Visual Fields defects assessed by Visual Fields Test at month 0 | month 0 |
| Visual Fields defects assessed by Visual Fields Test at month 24 | month 24 |
| Visual health assessed by Visual Function Questionnaire (VFQ-25) at month 0 | month 0 |
| Visual health assessed by Visual Function Questionnaire (VFQ-25) at month 24 | month 24 |
| ophthalmological examination: Refractive Error, Slit Lamp Exam, Ophthalmoscopy (Vitreous, Retina, Macula, Choroid, Optic Nerve), Intra-Ocular Pressure (IOP) Measurement at month 0 | month 0 |
| ophthalmological examination: Refractive Error, Slit Lamp Exam, Ophthalmoscopy (Vitreous, Retina, Macula, Choroid, Optic Nerve), Intra-Ocular Pressure (IOP) Measurement at month 3 | month 3 |
| ophthalmological examination: Refractive Error, Slit Lamp Exam, Ophthalmoscopy (Vitreous, Retina, Macula, Choroid, Optic Nerve), Intra-Ocular Pressure (IOP) Measurement at month 6 | month 6 |
| ophthalmological examination: Refractive Error, Slit Lamp Exam, Ophthalmoscopy (Vitreous, Retina, Macula, Choroid, Optic Nerve), Intra-Ocular Pressure (IOP) Measurement at month 12 | month 12 |
| ophthalmological examination: Refractive Error, Slit Lamp Exam, Ophthalmoscopy (Vitreous, Retina, Macula, Choroid, Optic Nerve), Intra-Ocular Pressure (IOP) Measurement at month 18 | month 18 |
| ophthalmological examination: Refractive Error, Slit Lamp Exam, Ophthalmoscopy (Vitreous, Retina, Macula, Choroid, Optic Nerve), Intra-Ocular Pressure (IOP) Measurement at month 24 | month 24 |
| Adverse Events assessed by inquiry at month 0 | month 0 |
| Adverse Events assessed by inquiry at month 24 | month 24 |
Countries
Denmark, France, Germany, Italy, Portugal, Spain, United Kingdom
Outcome results
None listed