Double-Masked Study of Safety and Efficacy of VEGF Trap-Eye in Subjects With DME - Full Text View

Sponsors and Collaborators:	Regeneron Pharmaceuticals Bayer
Information provided by:	Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00789477

Purpose

This is a Phase 2, doubled-masked, randomized study of the efficacy and safety of VEGF Trap-Eye in subjects with diabetic macular edema. Approximately 200 subjects will be randomized in the US, Canada, Australia and EU.

Condition	Intervention	Phase
Diabetic Macular Edema	Biological: VEGF Trap-Eye Procedure: Non-drug intervention	Phase II

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Edema

Drug Information available for: Aflibercept

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Double-Masked, Randomized, Controlled Study of the Safety, Tolerability and Biological Effect of Repeated Intravitreal Administration of VEGF Trap-Eye in Patients With Diabetic Macular Edema (DME)

Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:

Change in best corrected visual acuity [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in foveal thickness [ Time Frame: Weeks 24 and 52 ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	December 2008
Estimated Study Completion Date:	February 2011
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Dose 1	Biological: VEGF Trap-Eye Intravitreal injection, repeating dose
2: Experimental Dose 2	Biological: VEGF Trap-Eye Intravitreal injection, repeating dose
3: Experimental Dose 3	Biological: VEGF Trap-Eye Intravitreal injection, repeating dose
4: Experimental Dose 4	Biological: VEGF Trap-Eye Intravitreal injection, repeating dose
5: Active Comparator Non-drug comparator	Procedure: Non-drug intervention laser every 16 weeks as needed

Detailed Description:

Qualified subjects will be randomized to one of 5 treatment arms. The active (treatment) phase of the study will be 52 weeks, with a 6 month safety follow-up

Eligibility

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

Criteria

Inclusion Criteria:

Patients with clinically significant DME with central involvement
Adults 18 years or older with type 1 or 2 diabetes mellitus with diabetic macular edema
ETDRS BCVA: 20/40 to 20/320 (letter score of 73 to 24) in the study eye

Exclusion Criteria:

History of vitreoretinal surgery in the study eye
Panretinal laser photocoagulation or macular laser photocoagulation in the study eye within 3 months of screening
Previous use of intraocular or periocular corticosteroids in the study eye within 3 months of screening
Previous treatment with anti-angiogenic drugs in either eye (pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, etc) within 3 months of screening
Uncontrolled diabetes mellitus
Uncontrolled hypertension defined as systolic > 180mmHg or > 160 mmHg on 2 consecutive measurements or diastolic > 100 mmHg on optimal medical regimen
Ocular disorders in the study eye, other than DME, that may confound interpretation of study results

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00789477

Contacts

Contact: Maria Thurman

919-294-5075

maria.thurman@parexel.com

Locations

United States, Indiana
	Active, not recruiting
Indianapolis, Indiana, United States, 46280
United States, Massachusetts
	Active, not recruiting
Boston, Massachusetts, United States, 02114
United States, Michigan
	Active, not recruiting
Ann Arbor, Michigan, United States, 48104
United States, Nebraska
Eye Surgical Associates	Recruiting
Lincoln, Nebraska, United States, 68506

Sponsors and Collaborators

Regeneron Pharmaceuticals

Bayer

Investigators

Study Director:

Robert L Vitti, MD

Regeneron Pharmaceuticals

More Information

Responsible Party:	Regeneron Pharmaceuticals, Inc. ( Therapeutic Area Head )
Study ID Numbers:	VGFT-OD-0706
Study First Received:	November 7, 2008
Last Updated:	December 5, 2008
ClinicalTrials.gov Identifier:	NCT00789477
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Study placed in the following topic categories:

Signs and Symptoms
Macular Edema
Eye Diseases
Retinal Degeneration

Macular Degeneration
Edema
Retinal Diseases
Retinal degeneration

ClinicalTrials.gov processed this record on January 16, 2009