A Phase 2 Study Exploring The Safety And Efficacy Of Nove... | NCT00457470

Studies
A Phase 2 Study Exploring The Safety And Efficacy Of Novel Drug Treatment In Subjects With Diabetic Macular Edema (DME)

NCT00457470

Sponsor

Pfizer

Status

Withdrawn

Last Update Posted

May 4, 2015Estimated

Enrollment

0Actual

Phase

Phase 2

Conditions

Diabetes Mellitus
Diabetic Retinopathy

Interventions

AG-014699

Countries

Not provided

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

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Cancelled before first patient enrolled

Expanded Access Info

Start Date

Jun 2007

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Apr 4, 2007

First Submission Date that Met QC Criteria

Apr 5, 2007

First Posted Date

Apr 6, 2007Estimated

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

Apr 30, 2015

Last Update Posted Date

May 4, 2015Estimated

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Name	Type	Description	Arm Group Labels	Other Names
AG-014699	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change of retinal thickness at Day 15 or Day 25 depending on dosing regimen

Secondary Outcomes

Measure	Description	Time Frame
Proportion of subjects with reduction in retinal thickness from baseline in 2 months
Change in retinal thickness for 2 months
Change in visual acuity for 2 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

diabetic patients, either man or woman, with diabetic retinopathy, at least 18 years of age

Exclusion Criteria:

patients treated with laser therapy within the last 90 days
patients with likelyhood to require cataract surgery within 3 months
Uncontrolled diabetes

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Label	URL
To obtain contact information for a study center near you, click here.	View source

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus
D003930	Diabetic Retinopathy

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided