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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.

Publication ,  Journal Article
Do, DV; Nguyen, QD; Shah, SM; Browning, DJ; Haller, JA; Chu, K; Yang, K; Cedarbaum, JM; Vitti, RL; Ingerman, A; Campochiaro, PA
Published in: Br J Ophthalmol
February 2009

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 > or =250 microm 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 microm. At 4 weeks after injection, the median excess FTH was 59 microm 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 microm; 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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Published In

Br J Ophthalmol

DOI

EISSN

1468-2079

Publication Date

February 2009

Volume

93

Issue

2

Start / End Page

144 / 149

Location

England

Related Subject Headings

  • Vitreous Body
  • Visual Acuity
  • Vascular Endothelial Growth Factor A
  • Retina
  • Recombinant Fusion Proteins
  • Receptors, Vascular Endothelial Growth Factor
  • Prospective Studies
  • Pilot Projects
  • Ophthalmology & Optometry
  • Middle Aged
 

Citation

APA
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Do, D. V., Nguyen, Q. D., Shah, S. M., Browning, D. J., Haller, J. A., Chu, K., … Campochiaro, P. A. (2009). 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. Br J Ophthalmol, 93(2), 144–149. https://doi.org/10.1136/bjo.2008.138271
Do, D. V., Q. D. Nguyen, S. M. Shah, D. J. Browning, J. A. Haller, K. Chu, K. Yang, et al. “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.Br J Ophthalmol 93, no. 2 (February 2009): 144–49. https://doi.org/10.1136/bjo.2008.138271.
Do DV, Nguyen QD, Shah SM, Browning DJ, Haller JA, Chu K, Yang K, Cedarbaum JM, Vitti RL, Ingerman A, Campochiaro PA. 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. Br J Ophthalmol. 2009 Feb;93(2):144–149.

Published In

Br J Ophthalmol

DOI

EISSN

1468-2079

Publication Date

February 2009

Volume

93

Issue

2

Start / End Page

144 / 149

Location

England

Related Subject Headings

  • Vitreous Body
  • Visual Acuity
  • Vascular Endothelial Growth Factor A
  • Retina
  • Recombinant Fusion Proteins
  • Receptors, Vascular Endothelial Growth Factor
  • Prospective Studies
  • Pilot Projects
  • Ophthalmology & Optometry
  • Middle Aged