Safety and Tolerability of Intravitreal Administration of Vascular Endothelial Growth Factor (VEGF) Trap in Patients With Neovascular Age-Related Macular Degeneration (AMD)

This study is ongoing, but not recruiting participants.

Sponsored by:	Regeneron Pharmaceuticals
Information provided by:	Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00320775

Purpose

The purpose of this trial is to assess the ocular and systemic safety and tolerability of a single intravitreal injection of VEGF Trap in patients with subfoveal choroidal neovascularization (CNV) due to AMD.

Condition	Intervention	Phase
Macular Degeneration	Drug: VEGF Trap	Phase I

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

Drug Information available for: Aflibercept

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Safety Study
Official Title:	An Exploratory Study of the Safety, Tolerability and Biological Effect of Intravitreal Administration of VEGF Trap in Patients With Neovascular Age-Related Macular Degeneration

Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:

Safety and tolerability, bioeffect

Secondary Outcome Measures:

The effect of VEGF Trap administration on excess central retinal/lesion thickness
best-corrected Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity
extent of CNV leakage
anti-VEGF Trap antibodies in the systemic circulation
plasma levels of VEGF Trap

Estimated Enrollment:	96
Study Start Date:	June 2005

Detailed Description:

This study consists of three parts, Part A, Part B and Part C.

Eligibility

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

Criteria

Inclusion Criteria:

Subfoveal CNV secondary to AMD.
Central retinal/lesion thickness ≥ 250µm as measured by optical coherence tomography (OCT).
ETDRS best-corrected visual acuity of:
- 20/40 (73 letters) or worse
Clear ocular media and clear lens(es) to permit good quality stereoscopic fundus photography.

Exclusion Criteria:

Prior treatment with VEGF Trap, bevacizumab or ranibizumab.
Any investigational agent within 12 weeks of Visit 2 (Day 1).
Presence of other causes of CNV.
Active ocular infection.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00320775

Locations

United States, Arizona

Tuscon, Arizona, United States, 85704
United States, California

Loma Linda, California, United States, 92354
United States, Illinois

Chicago, Illinois, United States, 60637
United States, Maryland

Baltimore, Maryland, United States, 21287
United States, North Carolina

Charlotte, North Carolina, United States, 28120
United States, Ohio

Cleveland, Ohio, United States, 44195
United States, Oklahoma

Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania

Philadelphia, Pennsylvania, United States, 19107
United States, Tennessee

Nashville, Tennessee, United States, 37203
United States, Wisconsin

Madison, Wisconsin, United States, 53705

Sponsors and Collaborators

Regeneron Pharmaceuticals

Investigators

Study Director:

Avner Ingerman, MD

More Information

Study ID Numbers:	VGFT-OD-0502
Study First Received:	April 28, 2006
Last Updated:	July 25, 2007
ClinicalTrials.gov Identifier:	NCT00320775
Health Authority:	United States: Food and Drug Administration

Keywords provided by Regeneron Pharmaceuticals:

Neovascular Age-Related Macular Degeneration

Study placed in the following topic categories:

Eye Diseases
Retinal Degeneration
Macular Degeneration

Endothelial Growth Factors
Retinal Diseases
Retinal degeneration

Additional relevant MeSH terms:

Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009