NCT00248157

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2005

Shorter than P25 for phase_3

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 2, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 3, 2005

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

May 1, 2012

Status Verified

April 1, 2012

Enrollment Period

6 months

First QC Date

November 2, 2005

Last Update Submit

April 30, 2012

Conditions

Diabetic Retinopathy

Keywords

Diabetic retinopathyOctreotide acetate in microspheres

Outcome Measures

Primary Outcomes (1)

  • long-term safety and tolerability

Secondary Outcomes (1)

  • monitor long-term efficacy

Interventions

Octreotide acetate in microspheresDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • written informed consent provided prior to participation in the extension study
  • successful completion of study CSMS995 0804
  • willingness to comply with all study requirements

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

OctreotideMicrospheres

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Peptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and ProteinsEquipment and Supplies

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2005

First Posted

November 3, 2005

Study Start

November 1, 2005

Primary Completion

May 1, 2006

Study Completion

May 1, 2006

Last Updated

May 1, 2012

Record last verified: 2012-04