Extension Study of the 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

Diabetic Retinopathy Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00248157
• Other study ID #: CSMS995 0804E1
• Status: Terminated
• Phase: Phase 3
• First received: November 2, 2005
• Last updated: April 30, 2012
• Start date: November 2005
• Est. completion date: May 2006

Study information

• Verified date: April 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This multicenter, open-label extension study will evaluate the long-term tolerability and safety for patients completing study CSMS995 0802. During this extension study, all patients will receive open-label treatment of octreotide acetate in microspheres every 4 weeks for 2 years for the treatment of moderately severe to severe NPDR and low risk PDR.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 105
• Est. completion date: May 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• written informed consent provided prior to participation in the extension study

• successful completion of study CSMS995 0804

• willingness to comply with all study requirements

Exclusion Criteria:

• more than 8 weeks interval since the completion of study CSMS995 0804

• premature discontinuation from study CSMS995 0804

Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Diseases

Intervention

Drug:
• Octreotide acetate in microspheres

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	long-term safety and tolerability
Secondary	monitor long-term efficacy