A Multi-Center Trial to Evaluate the Safety and Efficacy of Pegaptanib Sodium (Macugen®) Injected Into the Eye Every 6 Weeks for up to 2 Years for Macular Swelling Associated With Diabetes - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00605280

Purpose

The purpose of the study is to test whether Macugen injected into the eye improves vision in more patients than the currently existing standard of care laser therapy. The safety of Macugen compared to standard of care laser will also be evaluated.

Condition	Intervention	Phase
Macular Edema Associated With Diabetes Mellitus	Drug: Macugen Drug: Standard of Care	Phase II Phase III

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Diabetes Dietary Sodium Edema

Drug Information available for: Pegaptanib sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase 2/3 Randomized, Controlled, Double-Masked, Multi-Center, Comparative Trial, in Parallel Groups, to Compare the Safety and Efficacy of Intravitreous Injections of 0.3 mg Pegaptanib Sodium (Macugen®), Given as Often as Every 6 Weeks for 2 Years, to Sham Injections in Subjects With Diabetic Macular Edema (DME) Involving the Center of the Macula.

Further study details as provided by Pfizer:

Primary Outcome Measures:

The proportion of subjects who, after one year, experience an improvement in vision from baseline. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The proportion of subjects with an improvement in vision at 1 and 2 years. [ Time Frame: 1 to 2 years ] [ Designated as safety issue: No ]
The proportion of eyes experiencing a change in the degree of retinopathy by 2 or more steps at 1 and 2 years. [ Time Frame: 1 to 2 years ] [ Designated as safety issue: No ]
Changes in average visual acuity over time. [ Time Frame: 1 to 2 years ] [ Designated as safety issue: No ]
Safety endpoints are all adverse events reported, whether deemed related to treatment or not and all laboratory abnormalities, whether deemed clinically relevant or not [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	300
Study Start Date:	September 2005
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Sham Control: Sham Comparator	Drug: Standard of Care Clinicians decision to use optional laser therapy.
Macugen: Experimental	Drug: Macugen Intravitreal injection of Macugen 0.3mg/90ul every 6 weeks up to 2 years.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

macular edema associated with diabetes
visual acuity between 20/50 and 20/200

Exclusion Criteria:

recent laser therapy in the eye
recent signs of uncontrolled diabetes
blood pressure worse than 160/100
severe cardiac disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00605280

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Show 66 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A5751013, EOP1013D
Study First Received:	January 18, 2008
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00605280
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

randomized, sham-controlled, multicenter, macular edema

Study placed in the following topic categories:

Metabolic Diseases
Eye Diseases
Diabetes Mellitus
Edema
Endocrine System Diseases
Macular Degeneration
Retinal Degeneration

Macular Edema
Signs and Symptoms
Endocrinopathy
Glucose Metabolism Disorders
Metabolic disorder
Retinal Diseases
Retinal degeneration

ClinicalTrials.gov processed this record on January 14, 2009