Trial to Assess the Efficacy of Neuroprotective Drugs Administered Topically to Prevent or Arrest Diabetic Retinopathy

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Diabetic Retinopathy

Intervention / Treatment
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* Drug: COLIRIOBCN070660
* Drug: Placebo
* Drug: Brimonidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with type 2 diabetes mellitus Diabetes duration ≥ 5 years Aged between 45-75 years-old 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. Informed Consent Exclusion Criteria: Previous laser photocoagulation Other diseases which may induce retinal degeneration (e.g. glaucoma) Subject with a refractive error ≥ ± 5 diopter Inadequate ocular media and/ or pupil dilatation that do not permit good quality fundus photography. Renal failure (creatinine > 1.4 mg/dl) HbA1C > 10 % in the previous 6 months and at Screening Subjects taking somatostatin or brimonidine, for any indication, in the previous 3 months 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. Pregnancy or nursing Hypersensitivity to the active substances to be tested or to any of the excipients Subject receiving systemic monoamine oxidase (MAO) inhibitor therapy or antidepressants which affect noradrenergic transmission (e.g. tricyclic antidepressants and mianserin)

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: COLIRIOBCN070660<br>COLIRIOBCN070660 Somatostatin 1mg/mL Eye drops, solution. One drop/eye administered twice a day. | Drug: COLIRIOBCN070660<br>* One drop per eye twice a day during 24 months<br>* Other names: Somatostatin eye drops;|
| Placebo Comparator: Placebo<br>Placebo Eye drops, solution. One drop/eye administered twice a day. | Drug: Placebo<br>* One drop per eye twice a day during 24 months<br>* Other names: placebo eye drops;|
| Experimental: Brimonidine<br>Brimonidine tartrate 2mg/mL One drop/eye administered twice a day. | Drug: Brimonidine<br>* One drop per eye twice a day during 24 months<br>* Other names: Brimonidine eye drops;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the Implicit Time assessed by mfERG (IT-mfERG) at month 6, 12, 18 and 24 |  | month 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 6 |  | month 6 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetic retinopathy