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

D. V. Do, Q. D. 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, D. V.; Nguyen, Q. D.; 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, D. V. ; Nguyen, Q. D. ; 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, Q. D.

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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