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

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)

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00248157

Enrollment

105

Registered

2005-11-03

Start date

2005-11-30

Completion date

2006-05-31

Last updated

2012-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Retinopathy

Keywords

Diabetic retinopathy, Octreotide acetate in microspheres

Brief 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.

Interventions

DRUGOctreotide acetate in microspheres

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame
long-term safety and tolerability	—

Secondary

Measure	Time frame
monitor long-term efficacy	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026