An exploratory study of the safety, tolerability and bioactivity of a single intravitreal injection of vascular endothelial growth factor Trap-Eye in patients with diabetic macular oedema

Diana V Do, Quan Dong Nguyen, S. M. Shah, D. J. Browning, J. A. Haller, K. Chu, K. Yang, J. M. Cedarbaum, R. L. Vitti, A. Ingerman, P. A. Campochiaro

Research output: Contribution to journalArticle

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Abstract

Aim: The aim of the study was to assess the safety and bioactivity of a single intravitreal injection of vascular endothelial growth factor (VEGF) Trap-Eye in subjects with diabetic macular oedema (DMO). Methods: Five subjects with DMO, foveal thickness ≥250 mm measured by optical coherence tomography (OCT), and best-corrected visual acuity (BCVA) between 20/40 and 20/320, were enrolled. Each participant received a single intravitreal injection of 4.0 mg of VEGF Trap-Eye followed by a 6-week observation period. Outcome measures included safety and biological activity, including changes in BCVA and excess retinal thickness assessed by OCT. Results: Injections of VEGF Trap-Eye were well tolerated with no ocular toxicity. One patient had an unrelated serious adverse event: hospitalisation for cellulitis of the left foot 27 days after injection of VEGF Trap-Eye. Median baseline BCVA was 36 ETDRS letters read at 4 m (not ETDRS visual acuity score; Snellen equivalent: 20/50) and median baseline excess central 1 mm foveal thickness (FTH) was 108 mm. At 4 weeks after injection, the median excess FTH was 59 mm and the median improvement in BCVA was nine letters. At 6 weeks after injection, four of the five patients showed improvement in excess FTH (median 74 μm; 31% reduction from baseline, p = 0.0625) and four of the five showed improvement in BCVA (median improvement of three letters). Conclusions: A single intravitreal injection of 4.0 mg of VEGF Trap-Eye was well tolerated and preliminary evidence of bioactivity was detected. These findings support additional studies investigating multiple injections of VEGF Trap-Eye in patients with DMO.

Original languageEnglish (US)
Pages (from-to)144-149
Number of pages6
JournalBritish Journal of Ophthalmology
Volume93
Issue number2
DOIs
StatePublished - Feb 1 2009

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Intravitreal Injections
Macular Edema
Vascular Endothelial Growth Factor A
Visual Acuity
Safety
Injections
Optical Coherence Tomography
Cellulitis
Foot
Hospitalization
Observation
Outcome Assessment (Health Care)

ASJC Scopus subject areas

  • Ophthalmology
  • Sensory Systems
  • Cellular and Molecular Neuroscience

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An exploratory study of the safety, tolerability and bioactivity of a single intravitreal injection of vascular endothelial growth factor Trap-Eye in patients with diabetic macular oedema. / Do, Diana V; Nguyen, Quan Dong; Shah, S. M.; Browning, D. J.; Haller, J. A.; Chu, K.; Yang, K.; Cedarbaum, J. M.; Vitti, R. L.; Ingerman, A.; Campochiaro, P. A.

In: British Journal of Ophthalmology, Vol. 93, No. 2, 01.02.2009, p. 144-149.

Research output: Contribution to journalArticle

Do, Diana V ; Nguyen, Quan Dong ; Shah, S. M. ; Browning, D. J. ; Haller, J. A. ; Chu, K. ; Yang, K. ; Cedarbaum, J. M. ; Vitti, R. L. ; Ingerman, A. ; Campochiaro, P. A. / An exploratory study of the safety, tolerability and bioactivity of a single intravitreal injection of vascular endothelial growth factor Trap-Eye in patients with diabetic macular oedema. In: British Journal of Ophthalmology. 2009 ; Vol. 93, No. 2. pp. 144-149.
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abstract = "Aim: The aim of the study was to assess the safety and bioactivity of a single intravitreal injection of vascular endothelial growth factor (VEGF) Trap-Eye in subjects with diabetic macular oedema (DMO). Methods: Five subjects with DMO, foveal thickness ≥250 mm measured by optical coherence tomography (OCT), and best-corrected visual acuity (BCVA) between 20/40 and 20/320, were enrolled. Each participant received a single intravitreal injection of 4.0 mg of VEGF Trap-Eye followed by a 6-week observation period. Outcome measures included safety and biological activity, including changes in BCVA and excess retinal thickness assessed by OCT. Results: Injections of VEGF Trap-Eye were well tolerated with no ocular toxicity. One patient had an unrelated serious adverse event: hospitalisation for cellulitis of the left foot 27 days after injection of VEGF Trap-Eye. Median baseline BCVA was 36 ETDRS letters read at 4 m (not ETDRS visual acuity score; Snellen equivalent: 20/50) and median baseline excess central 1 mm foveal thickness (FTH) was 108 mm. At 4 weeks after injection, the median excess FTH was 59 mm and the median improvement in BCVA was nine letters. At 6 weeks after injection, four of the five patients showed improvement in excess FTH (median 74 μm; 31{\%} reduction from baseline, p = 0.0625) and four of the five showed improvement in BCVA (median improvement of three letters). Conclusions: A single intravitreal injection of 4.0 mg of VEGF Trap-Eye was well tolerated and preliminary evidence of bioactivity was detected. These findings support additional studies investigating multiple injections of VEGF Trap-Eye in patients with DMO.",
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AU - Nguyen, Quan Dong

AU - Shah, S. M.

AU - Browning, D. J.

AU - Haller, J. A.

AU - Chu, K.

AU - Yang, K.

AU - Cedarbaum, J. M.

AU - Vitti, R. L.

AU - Ingerman, A.

AU - Campochiaro, P. A.

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