Extension Study of Long-term Safety and Tolerability of Octreotide Acetate in Patients With Moderately Severe or Severe Non-proliferative Diabetic Retinopathy or Low Risk Proliferative Diabetic Retinopathy
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ClinicalTrials.gov Identifier: NCT00248131 |
Recruitment Status :
Terminated
First Posted : November 3, 2005
Last Update Posted : April 10, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetic Retinopathy | Drug: Octreotide acetate in microspheres | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 260 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Octreotide Acetate in Microspheres in the Therapy of Patients With Moderately Severe or Severe Non-proliferative Diabetic Retinopathy (NPDR) or Low Risk Proliferative Diabetic Retinopathy (PDR) |
Study Start Date : | November 2005 |
Actual Primary Completion Date : | July 2006 |
Actual Study Completion Date : | July 2006 |

- long-term safety and tolerability
- monitor long-term efficacy

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- written informed consent provided prior to participation in the extension study
- successful completion of study CSMS995 0802
- willingness to comply with all study requirements
Exclusion Criteria:
- more than 8 weeks interval since the completion of study CSMS995 0802
- premature discontinuation from study CSMS995 0802
Other protocol-defined inclusion/exclusion criteria may apply.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00248131
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Responsible Party: | Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00248131 History of Changes |
Other Study ID Numbers: |
CSMS9950802E1 |
First Posted: | November 3, 2005 Key Record Dates |
Last Update Posted: | April 10, 2012 |
Last Verified: | April 2012 |
Diabetic retinopathy, octreotide acetate in microspheres |
Retinal Diseases Diabetic Retinopathy Eye Diseases Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases Diabetes Complications |
Diabetes Mellitus Endocrine System Diseases Octreotide Gastrointestinal Agents Antineoplastic Agents, Hormonal Antineoplastic Agents |