Octreotide Acetate in Microspheres in Patients With Diabe... | NCT00130845

Studies
Octreotide Acetate in Microspheres in Patients With Diabetic Retinopathy

NCT00130845

Sponsor

Novartis

Status

Completed

Last Update Posted

Nov 17, 2011Estimated

Enrollment

312Actual

Phase

Phase 3

Conditions

Diabetic Retinopathy

Interventions

Octreotide Acetate in Microspheres
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
59318

Status Module

Record Verification Date

Nov 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2000

Primary Completion Date

Dec 2005Actual

Completion Date

Dec 2005Actual

First Submitted Date

Aug 15, 2005

First Submission Date that Met QC Criteria

Aug 15, 2005

First Posted Date

Aug 16, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 16, 2011

Last Update Posted Date

Nov 17, 2011Estimated

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

312Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Octreotide Acetate in Microspheres	Experimental		Drug: Octreotide Acetate in Microspheres
Placebo	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Octreotide Acetate in Microspheres	Drug		Octreotide Acetate in Microspheres
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
time to progression of diabetic retinopathy

Secondary Outcomes

Measure	Description	Time Frame
time to development or progression of macular edema,
time to moderate vision loss

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Customer Information	Novartis	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novartis		East Hanover	New Jersey	07936	United States

Condition Browse Module

MeSH Terms

ID	Term
D003930	Diabetic Retinopathy

Ancestor Terms

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases
D003925	Diabetic Angiopathies
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015282	Octreotide
D008863	Microspheres

Ancestor Terms

ID	Term
D010456	Peptides, Cyclic
D047028	Macrocyclic Compounds
D011083	Polycyclic Compounds
D010455	Peptides

Browse Leaves

Not provided

Browse Branches

Not provided