Randomized, Single-Masked, Long-Term, Safety and Tolerability Study of VEGF Trap-Eye in AMD - Full Text View

Sponsor:	Regeneron Pharmaceuticals
Collaborator:	Bayer
Information provided by (Responsible Party):	Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00527423

Purpose

Rollover study for subjects in prior VEGF Trap-Eye Phase I and II studies. Primary objective is to assess long-term safety and tolerability of continuing intravitreal treatment in subjects with wet age-related macular degeneration.

Condition	Intervention	Phase
Macular Degeneration	Drug: VEGF Trap Eye	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	An Randomized, Single-Masked , Long-Term, Safety and Tolerability Study of Intravitreal VEGF Trap-Eye in Subjects With Neovascular Age-related Macular Degeneration

Resource links provided by NLM:

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

MedlinePlus related topics: Macular Degeneration

Drug Information available for: Aflibercept

U.S. FDA Resources

Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:

Assessment of safety and tolerability as assessed by adverse events, laboratory assessments, vital signs, visual acuity and intraocular pressure. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The secondary endpoints include: Frequency of re-treatment • Visual acuity parameters (ETDRS letters) [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment:	157
Study Start Date:	August 2007
Study Completion Date:	October 2011
Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Intervention Details:

Intravitreal injection

Other Name: IVT

Detailed Description:

Randomized, Single-Masked Phase II study for subjects previously enrolled in Phase I and II studies for wet age-related macular degeneration with VEGF Trap-Eye intravitreal injection as treatment.Long term (3 years) treatment is intended to measure safety and tolerability, as well as frequency of re-treatment and the effect of VEGF Trap-Eye on best corrected visual acuity (BCVA).

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Prior participation in VEGF Trap-Eye Phase I and II studies

Exclusion Criteria:

Any ocular or systemic adverse events that would preclude participation
Presence of any condition that would jeopardize subject's participation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00527423

Show 33 Study Locations

Sponsors and Collaborators

Regeneron Pharmaceuticals

Bayer

Investigators

Study Director:

Clinical Trial Management

Regeneron Pharmaceuticals

More Information

No publications provided

Responsible Party:	Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00527423 History of Changes
Other Study ID Numbers:	VGFT-OD-0702
Study First Received:	September 6, 2007
Last Updated:	November 1, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Regeneron Pharmaceuticals:

VEGF Trap Eye
macular degeneration
AMD
Neovascular Age-Related Macular Degeneration

Additional relevant MeSH terms:

Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on February 09, 2012