Pegaptanib sodium for macular edema secondary to central retinal vein occlusion

John J. Wroblewski, John A. Wells, Anthony P. Adamis, Ronald R. Buggage, Emmett T. Cunningham, Mauro Goldbaum, David R. Guyer, Barrett Katz, Michael M. Altaweel

Research output: Contribution to journalArticle

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Abstract

Objectives: To assess the safety and efficacy of intra- vitreous pegaptanib sodium for the treatment of macular edema following central retinal vein occlusion (CRVO). Design: This dose-ranging, double-masked, multi- center, phase 2 trial included subjects with CRVO for 6 months' or less duration randomly assigned (1:1:1) to receive pegaptanib sodium or sham injections every 6 weeks for 24 weeks (0.3 mg and 1 mg, n = 33; sham, n = 32). Main Outcome Measure: Visual acuity at week 30. Results: In the primary analysis at week 30, 12 of 33 (36%) subjects treated with 0.3 mg of pegaptanib sodium and 13 of 33 (39%) treated with 1 mg gained 15 or more letters from baseline vs 9 of 32 (28%) sham- treated subjects (P =.48 for 0.3 mg and P =.35 for 1 mg of pegaptanib sodium vs sham). In secondary analyses, subjects treated with pegaptanib sodium were less likely to lose 15 or more letters (9% and 6%; 0.3-mg and 1-mg pegaptanib sodium groups, respectively) compared with sham-treated eyes (31%; P = .03 for 0.3 mg and P = .01 for 1 mg of pegaptanib sodium vs sham) and showed greater improvement in mean visual acuity ( + 7.1 and +9.9, respectively, vs -3.2 letters with sham; P=.09 for 0.3 mg and P = .02 for 1 mg of pegaptanib sodium vs sham). By week 1, the mean central retinal thickness decreased in the 0.3-mg and 1-mg pegaptanib sodium groups by 269 μm and 210 μm, respectively, vs 5 μm with sham (P< .001). Conclusions: Based on this 30-week study, intravitre- ous pegaptanib sodium appears to provide visual and anatomical benefits in the treatment of macular edema following CRVO.

Original languageEnglish (US)
Pages (from-to)374-380
Number of pages7
JournalArchives of Ophthalmology
Volume127
Issue number4
DOIs
StatePublished - Apr 2009
Externally publishedYes

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Retinal Vein
Retinal Vein Occlusion
Macular Edema
Visual Acuity
pegaptanib
Outcome Assessment (Health Care)
Safety

ASJC Scopus subject areas

  • Ophthalmology

Cite this

Wroblewski, J. J., Wells, J. A., Adamis, A. P., Buggage, R. R., Cunningham, E. T., Goldbaum, M., ... Altaweel, M. M. (2009). Pegaptanib sodium for macular edema secondary to central retinal vein occlusion. Archives of Ophthalmology, 127(4), 374-380. https://doi.org/10.1001/archophthalmol.2009.14

Pegaptanib sodium for macular edema secondary to central retinal vein occlusion. / Wroblewski, John J.; Wells, John A.; Adamis, Anthony P.; Buggage, Ronald R.; Cunningham, Emmett T.; Goldbaum, Mauro; Guyer, David R.; Katz, Barrett; Altaweel, Michael M.

In: Archives of Ophthalmology, Vol. 127, No. 4, 04.2009, p. 374-380.

Research output: Contribution to journalArticle

Wroblewski, JJ, Wells, JA, Adamis, AP, Buggage, RR, Cunningham, ET, Goldbaum, M, Guyer, DR, Katz, B & Altaweel, MM 2009, 'Pegaptanib sodium for macular edema secondary to central retinal vein occlusion', Archives of Ophthalmology, vol. 127, no. 4, pp. 374-380. https://doi.org/10.1001/archophthalmol.2009.14
Wroblewski JJ, Wells JA, Adamis AP, Buggage RR, Cunningham ET, Goldbaum M et al. Pegaptanib sodium for macular edema secondary to central retinal vein occlusion. Archives of Ophthalmology. 2009 Apr;127(4):374-380. https://doi.org/10.1001/archophthalmol.2009.14
Wroblewski, John J. ; Wells, John A. ; Adamis, Anthony P. ; Buggage, Ronald R. ; Cunningham, Emmett T. ; Goldbaum, Mauro ; Guyer, David R. ; Katz, Barrett ; Altaweel, Michael M. / Pegaptanib sodium for macular edema secondary to central retinal vein occlusion. In: Archives of Ophthalmology. 2009 ; Vol. 127, No. 4. pp. 374-380.
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abstract = "Objectives: To assess the safety and efficacy of intra- vitreous pegaptanib sodium for the treatment of macular edema following central retinal vein occlusion (CRVO). Design: This dose-ranging, double-masked, multi- center, phase 2 trial included subjects with CRVO for 6 months' or less duration randomly assigned (1:1:1) to receive pegaptanib sodium or sham injections every 6 weeks for 24 weeks (0.3 mg and 1 mg, n = 33; sham, n = 32). Main Outcome Measure: Visual acuity at week 30. Results: In the primary analysis at week 30, 12 of 33 (36{\%}) subjects treated with 0.3 mg of pegaptanib sodium and 13 of 33 (39{\%}) treated with 1 mg gained 15 or more letters from baseline vs 9 of 32 (28{\%}) sham- treated subjects (P =.48 for 0.3 mg and P =.35 for 1 mg of pegaptanib sodium vs sham). In secondary analyses, subjects treated with pegaptanib sodium were less likely to lose 15 or more letters (9{\%} and 6{\%}; 0.3-mg and 1-mg pegaptanib sodium groups, respectively) compared with sham-treated eyes (31{\%}; P = .03 for 0.3 mg and P = .01 for 1 mg of pegaptanib sodium vs sham) and showed greater improvement in mean visual acuity ( + 7.1 and +9.9, respectively, vs -3.2 letters with sham; P=.09 for 0.3 mg and P = .02 for 1 mg of pegaptanib sodium vs sham). By week 1, the mean central retinal thickness decreased in the 0.3-mg and 1-mg pegaptanib sodium groups by 269 μm and 210 μm, respectively, vs 5 μm with sham (P< .001). Conclusions: Based on this 30-week study, intravitre- ous pegaptanib sodium appears to provide visual and anatomical benefits in the treatment of macular edema following CRVO.",
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AU - Cunningham, Emmett T.

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AU - Guyer, David R.

AU - Katz, Barrett

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