A Clinical Trial to Explore the Safety and Efficacy of In... | NCT00354445

Studies
A Clinical Trial to Explore the Safety and Efficacy of Injections of Macugen When Given Every 6 Weeks in Subjects With AMD

NCT00354445

Sponsor

Eyetech Pharmaceuticals

Status

Unknown status

Last Update Posted

Jan 15, 2007Estimated

Enrollment

1,000

Phase

Phase 4

Conditions

Age-Related Macular Degeneration (AMD)

Interventions

pegaptanib sodium (Macugen)

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

Official Title

A Phase IV, Open Label, Multi-Center, Study of Maintenance Intravitreous Injections of Macugen (Pegaptanib Sodium) Given Every 6 Weeks for 48 Weeks in Subjects With Subfoveal Neovascular Age-Related Macular Degeneration (AMD) Initially Treated With a Modality Resulting in Maculopathy Improvement

Status Module

Record Verification Date

Jan 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Jun 2006

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jul 18, 2006

First Submission Date that Met QC Criteria

Jul 18, 2006

First Posted Date

Jul 20, 2006Estimated

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

Jan 12, 2007

Last Update Posted Date

Jan 15, 2007Estimated

Name	Class
Pfizer	INDUSTRY

Description Module

Brief Summary

The purpose of this study is to explore the safety and efficacy of Macugen given as maintenance therapy in patients who have had initial success with another AMD treatment. Patients must have 1, but not more than 3 prior treatments for Neovascular AMD.

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000

Name	Type	Description	Arm Group Labels	Other Names
pegaptanib sodium (Macugen)	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subfoveal CNV secondary to AMD
At least 1 but not more than 3 prior treatments for AMD

Exclusion Criteria:

Subfoveal scar or subfoveal atrophy
Significant media opacities, including cataract, which might interfere with visual acuity

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Macugen Information	Contact	1-866-622-8436

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Retina Research Institute of Texas, LLC	Recruiting	Abilene	Texas	79606	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20472746	Derived	Friberg TR, Tolentino M; LEVEL Study Group; Weber P, Patel S, Campbell S, Goldbaum M. Pegaptanib sodium as maintenance therapy in neovascular age-related macular degeneration: the LEVEL study. Br J Ophthalmol. 2010 Dec;94(12):1611-7. doi: 10.1136/bjo.2009.174946. Epub 2010 May 14.

ID	Term
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases