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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Double-masked, Sham-controlled Phase 3 Study of the Efficacy, Safety and Tolerability of Repeated Intravitreal Administration of VEGF Trap-Eye in Subjects With Macular Edema Secondary to

Brief Summary: To determine the efficacy of vascular endothelial growth factor (VEGF) Trap-Eye injected into the eye on vision function in subjects with macular edema as a consequence of central retinal vein occlusion

Detailed Summary:
Sponsor: Bayer

Current Primary Outcome: Percentage of Participants Who Gained at Least 15 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 24 With Discontinued Participants Before Week 24 Evaluated as Failures [ Time Frame: Baseline and Week 24 ]

Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 24 (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.


Original Primary Outcome: The proportion of subjects who gain at least 15 letters in BCVA on the EDTRS chart compared with baseline at the Week 24 endpoint [ Time Frame: Week 24 ]

Current Secondary Outcome:

  • Change From Baseline in BCVA as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 24 - Last Observation Carried Forward (LOCF) [ Time Frame: Baseline and 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. However, because this was assessed at the screening visit, subjects may have had a higher BCVA recorded at the baseline visit and would not have been excluded from the study.
  • Change From Baseline in Central Retinal Thickness (CRT) at Week 24 - LOCF [ Time Frame: Baseline and Week 24 ]
  • Percentage of Participants Who Developed Neovascularization During the First 24 Weeks [ Time Frame: From baseline until Week 24 ]
    Formation of blood vessels in the anterior segment, optic disc, or elsewhere in the fundus up to Week 24
  • Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Total Score at Week 24 - LOCF [ Time Frame: Baseline and Week 24 ]
    The NEI VFQ-25 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
  • Change From Baseline in European Five-dimensional Health Scale (EQ-5D) Score at Week 24 - LOCF [ Time Frame: Baseline and Week 24 ]
    EQ-5D is a quality of life questionnaire based on a scale from -0.594 (worst) to 1.00 (best).


Original Secondary Outcome:

  • Change from baseline in BCVA score [ Time Frame: Week 24 ]
  • Absolute change from baseline in central retinal thickness, assessed by OCT [ Time Frame: Week 24 ]
  • Proportion of subjects progressing to anterior segment neovascularization, neovascularization of the optic disc (NVD), or neovascularization of the retina elsewhere (NVE) requiring pan-retinal photocoagulation [ Time Frame: Week 24 ]
  • Change in the NEI-VFQ-25 total score from baseline [ Time Frame: Week 24 ]
  • Change in the EQ-5D score from baseline [ Time Frame: Week 24 ]


Information By: Bayer

Dates:
Date Received: October 30, 2009
Date Started: October 2009
Date Completion:
Last Updated: October 27, 2014
Last Verified: October 2014