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Completed

NCT Number: NCT00943072

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

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.

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Key information

Conditions

Macular Edema Secondary to Central Retinal Vein Occlusion Cardiovascular Diseases Embolism and Thrombosis Eye Diseases Macular Degeneration Macular Edema Retinal Degeneration Retinal Diseases Retinal Vein Occlusion Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Vancouver, British Columbia, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VEGF Trap-Eye 2.0mg

Biological

Monthly intravitreal injection out to the Week 24 Primary endpoint

sham

Drug

Monthly sham intravitreal injection out to Week 24 Primary Endpoint

Primary outcomes

  1. 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

    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 outcomes

  1. 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

    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.

  2. Change From Baseline in Central Retinal Thickness (CRT) at Week 24 - LOCF

    Time frame: Baseline and at Week 24

  3. 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

  4. Change From Baseline in the NEI VFQ-25 in Total Score at Week 24 (LOCF)

    Time frame: Baseline and at Week 24

    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.

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Collaborators

  • Bayer

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2012
First posted
Jul 21, 2009
Registry last updated
May 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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