Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Central Retinal Vein Occlusion (CRVO) - Full Text View

Purpose

This is a phase 3 study to determine the efficacy of VEGF Trap-Eye injected into the eye on vision function in subjects with macular edema as a consequence of central retinal vein occlusion.

Condition	Intervention	Phase
Macular Edema Secondary to Central Retinal Vein Occlusion	Biological: VEGF Trap-Eye 2.0mg Drug: Sham	Phase 3


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 Randomized, Double Masked, Controlled Phase 3 Study of the Efficacy, Safety, and Tolerability of Repeated Intravitreal Administration of Vascular Endothelial Growth Factor Trap-Eye in Subjects With Macular Edema Secondary to Central Retinal Vein Occlusion

Resource links provided by NLM:

Genetics Home Reference related topics: tumor necrosis factor receptor-associated periodic syndrome

MedlinePlus related topics: Edema

Drug Information available for: Aflibercept

Genetic and Rare Diseases Information Center resources: Periodic Fever, Familial, Autosomal Dominant

U.S. FDA Resources

Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:

Percentage of Participants Who Gained at Least 15 Letters in BCVA at Week 24 as Measured by ETDRS Letter Score [ Time Frame: Baseline and at Week 24 ] [ Designated as safety issue: No ]
Percentage values indicate the number of subjects in each arm who were able to read an additional 15 letters or more at Week 24 compared to baseline.

Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 24 letters (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning.

Secondary Outcome Measures:

Change From Baseline in BCVA as Measured by ETDRS Letter Score at Week 24 - Last Observation Carried Forward (LOCF) [ Time Frame: Baseline and at Week 24 ] [ Designated as safety issue: No ]
Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 24 (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning.
Change From Baseline in Central Retinal Thickness (CRT) at Week 24 - LOCF [ Time Frame: Baseline and at Week 24 ] [ Designated as safety issue: No ]
Percentage of Participants Progressing to Any of the Following: Anterior Segment Neovascularization, New Vessels of the Disc (NVD) or New Vessels Elsewhere (NVE) During the First 24 Weeks [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
Change From Baseline in the NEI VFQ-25 in Total Score at Week 24 (LOCF) [ Time Frame: Baseline and at Week 24 ] [ Designated as safety issue: No ]
The NEI VFQ-25 assesses visual function and quality of life. Total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales which are all scored from 0-100. To reach the overall composite score, each sub-scale score is averaged in order to give each sub-scale equal weight.


Enrollment:	189
Study Start Date:	July 2009
Study Completion Date:	April 2012
Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: VEGF Trap-Eye Monthly IVT injection of VEGF Trap-Eye 2.0 mg until Week 24 Primary Endpoint	Biological: VEGF Trap-Eye 2.0mg Monthly intravitreal injection out to the Week 24 Primary endpoint
Sham Comparator: Sham Monthly Sham IVT injection until Week 24 Primary Endpoint	Drug: Sham Monthly sham intravitreal injection out to Week 24 Primary Endpoint

Eligibility


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

Criteria

Inclusion Criteria:

Subjects at least 18 years of age with center-involved macular edema secondary to CRVO with mean central retinal thickness ≥ 250 μm on OCT
ETDRS best corrected visual acuity of 20/40 to 20/320 (73 to 24 letters) in the study eye

Exclusion Criteria:

Previous treatment with anti-angiogenic drugs in the study eye (Pegaptanib sodium,anecortave acetate, bevacizumab, ranibizumab, etc.)
Prior panretinal laser photocoagulation or macular laser photocoagulation in the study eye
CRVO disease duration > 9 months from date of diagnosis
Previous use of intraocular corticosteroids in the study eye or use of periocular corticosteroids in the study eye within the 3 months prior to Day 1
Iris neovascularization, vitreous hemorrhage, traction retinal detachment, or preretinal fibrosis involving the macula in either the study eye or fellow eye

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00943072

Show 61 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:	NCT00943072 History of Changes
Other Study ID Numbers:	VGFT-OD-0819
Study First Received:	July 10, 2009
Results First Received:	October 19, 2012
Last Updated:	April 16, 2013
Health Authority:	United States: Food and Drug Administration India: Drugs Controller General of India Canada: Health Canada Israel: Ministry of Health Colombia: Institutional Review Board

Keywords provided by Regeneron Pharmaceuticals:


Macular edema Retinal vein occlusion CRVO VEGF Trap-Eye	best-corrected visual acuity Regeneron COPERNICUS

Additional relevant MeSH terms:


Macular Edema Retinal Vein Occlusion Cardiovascular Diseases Embolism and Thrombosis Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases	Thrombosis Vascular Diseases Venous Thrombosis Endothelial Growth Factors Growth Substances Pharmacologic Actions Physiological Effects of Drugs

ClinicalTrials.gov processed this record on March 01, 2015