Octreotide Acetate in Microspheres in Patients With Diabetic Retinopathy

Study Overview
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Brief Summary
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The most common ocular disease in patients with diabetes, diabetic retinopathy, is present in approximately 40% of diabetic patients; about 8% of diabetic patients have vision threatening diabetic retinopathy. Although intensive control of blood glucose has been shown to reduce the development and progression of diabetic retinopathy, intensive control of glucose is usually not achieved in clinical practice.

Official Title
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A Randomized, Controlled Study on the Efficacy and Safety of Octreotide Acetate in Microspheres in the Therapy of Patients With Moderately Severe or Severe Non-proliferate Diabetic Retinopathy (NPDR) or Low Risk Proliferative Diabetic Retinopathy (PDR)

Conditions
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Diabetic Retinopathy

Intervention / Treatment
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* Drug: Octreotide Acetate in Microspheres 20 mg
* Drug: Octreotide Acetate in Microspheres
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females with type 1 and type 2 diabetes mellitus Moderately severe or severe NPDR or mild PDR in at least one eye: with an Early Treatment Diabetic Retinopathy Study (ETDRS) visual score of > 35 letters; and not previously treated with scatter photocoagulation. HbA1c < 13% at study entry Exclusion Criteria: Condition which could interfere with the assessment of retinopathy progression History of symptomatic gallstones without cholecystectomy Brittle diabetes or history of severe hypoglycemia unawareness Previous treatment with a somatostatin analogue

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Octreotide Acetate in Microspheres 20 mg<br>20 mg will be administered im once every 4 weeks | Drug: Octreotide Acetate in Microspheres 20 mg<br> <br> |
| Experimental: Octreotide Acetate in Microspheres 30 mg<br>30 mg will be administered im once every 4 weeks | Drug: Octreotide Acetate in Microspheres<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to progression of diabetic retinopathy |  | throughout study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to development or progression of macular edema, and |  | Baseline through end of study | 
| time to moderate vision loss |  | Baseline through end of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic retinopathy,Octreotide Acetate in Microspheres