Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration (AMD) (VIEW 2) - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00637377

Purpose

This study is a phase III, double-masked, randomized, study of the efficacy and safety of VEGF Trap-Eye in patients with neovascular age-related macular degeneration. Approximately 1200 patients will be randomized in Europe, Asia, Japan, Australia and South America.

Condition	Intervention	Phase
Macular Degeneration	Drug: VEGF Trap-Eye Drug: Ranibizumab	Phase III

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

Drug Information available for: Ranibizumab 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 Randomized, Double Masked, Active Controlled, Phase 3 Study of the Efficacy, Safety, and Tolerability of Repeated Doses of Intravitreal VEGF Trap in Subjects With Neovascular Age-Related Macular Degeneration (AMD).

Further study details as provided by Bayer:

Primary Outcome Measures:

The proportion of subjects who maintain vision at Week 52, where a subject is classified as maintaining vision if the subject has lost fewer than 15 letters on the ETDRS chart compared to baseline (ie, prevention of moderate vision loss) [ Time Frame: week 52 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Mean change from baseline in BCVA as measured by ETDRS letter score at Week 52 [ Time Frame: week 52 ] [ Designated as safety issue: Yes ]
The proportion of subjects who gain at least 15 letters of vision at Week 52 [ Time Frame: week 52 ] [ Designated as safety issue: No ]
Mean change from baseline in total NEI VFQ-25 score at Week 52 [ Time Frame: week 52 ] [ Designated as safety issue: No ]
Mean change from baseline in CNV area at Week 52 [ Time Frame: week 52 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1200
Study Start Date:	April 2008
Estimated Study Completion Date:	July 2011
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 3: Experimental	Drug: VEGF Trap-Eye 2.0 mg VEGF Trap-Eye administered every 8 weeks (including one additional 2,0 mg dose at Week 4) during the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
Arm 1: Experimental	Drug: VEGF Trap-Eye 0.5 mg VEGF Trap-Eye administered every 4 weeks during the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
Arm 2: Experimental	Drug: VEGF Trap-Eye 2.0 mg VEGF Trap-Eye administered every 4 weeks during the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
Arm 4: Active Comparator	Drug: Ranibizumab 0.5 mg administered every 4 weeks during the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.

Eligibility

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

Criteria

Inclusion Criteria:

Signed informed consent.
Men and women >/=50 years of age.
Active primary or recurrent subfoveal CNV lesions secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by FA in the study eye.
ETDRS best-corrected visual acuity of: 20/40 to 20/320 (letter score of 73 to 25) in the study eye at 4 meters.
Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures.
Able to read, (or, if unable to read due to visual impairment, be read to verbatim by the person administering the informed consent or a family member) understand and willing to sign the informed consent form.

Exclusion Criteria:

Any prior ocular (in the study eye) or systemic treatment or surgery for neovascular AMD, except dietary supplements or vitamins.
Any prior or concomitant therapy with another investigational agent to treat neovascular AMD in the study eye.
Any prior treatment with anti-VEGF agents in the study eye.
Total lesion size >12 disc areas (30.5 mm�, including blood, scars and neovascularization) as assessed by FA in the study eye.
Subretinal hemorrhages that is either 50% or more of the total lesion area, or if the blood is under the fovea and is 1 or more disc areas in size in the study eye (if the blood is under the fovea, then the fovea must be surrounded by 270 degrees by visible CNV).
Scar or fibrosis making up >50% of the total lesion in the study eye.
Scar, fibrosis, or atrophy involving the center of the fovea in the study eye.
Presence of retinal pigment epithelial tears or rips involving the macula in the study eye.
History of any vitreous hemorrhage within 4 weeks prior to Visit 1 in the study eye.
Presence of other causes of CNV in the study eye.
Prior vitrectomy in the study eye.
History of retinal detachment or treatment or surgery for retinal detachment in the study eye.
Any history of macular hole of stage 2 and above in the study eye.
Any intraocular or periocular surgery within 3 months of Day 1 on the study eye, except lid surgery, which may not have taken place within 1 month of Day 1, as long as it is unlikely to interfere with the injection.
History or clinical evidence of diabetic retinopathy, diabetic macular edema or any retinal vascular disease other than AMD in either eye.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00637377

Contacts

Contact: Bayer Clinical Trial Contact

clinical-trials-contact@bayerhealthcare.com

Show 260 Study Locations

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

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No publications provided

Responsible Party:	Bayer Schering Pharma AG ( Therapeutic Area Head )
Study ID Numbers:	91689, EurdaCT No.: 2007-000583-25
Study First Received:	March 12, 2008
Last Updated:	May 4, 2009
ClinicalTrials.gov Identifier:	NCT00637377 History of Changes
Health Authority:	Switzerland: Ethikkommission

Keywords provided by Bayer:

Eye diseases
Vision Impairment and Blindness
Eyes and Vision

Seniors
Neovascular Age-Related Macular Degeneration (AMD)
Retinal Disease

Study placed in the following topic categories:

Eye Diseases
Mitogens
Retinal Degeneration
Macular Degeneration

Blindness
Endothelial Growth Factors
Retinal Diseases
Vision, Low

Additional relevant MeSH terms:

Growth Substances
Eye Diseases
Physiological Effects of Drugs
Retinal Degeneration

Macular Degeneration
Endothelial Growth Factors
Pharmacologic Actions
Retinal Diseases

ClinicalTrials.gov processed this record on May 07, 2009