DME And VEGF Trap-Eye: INvestigation of Clinical Impact - Full Text View

Sponsor:	Regeneron Pharmaceuticals
Collaborator:	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: macular laser therapy	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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)

Resource links provided by NLM:

Genetics Home Reference related topics: age-related macular degeneration X-linked juvenile retinoschisis

MedlinePlus related topics: Edema

Drug Information available for: Aflibercept

U.S. FDA Resources

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 ]

Enrollment:	219
Study Start Date:	December 2008
Study Completion Date:	September 2010
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

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

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

Show 47 Study Locations

Sponsors and Collaborators

Regeneron Pharmaceuticals

Bayer

Investigators

Study Director:

Robert L Vitti, MD

Regeneron Pharmaceuticals

More Information

No publications provided

Responsible Party:	Therapeutic Area Head, Regeneron Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00789477 History of Changes
Other Study ID Numbers:	VGFT-OD-0706
Study First Received:	November 7, 2008
Last Updated:	May 2, 2011
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada; Austria: Ethikkommission

Additional relevant MeSH terms:

Edema
Macular Edema
Signs and Symptoms
Macular Degeneration

Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on February 09, 2012