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 language | English (US) |
|---|---|
| Pages (from-to) | 374-380 |
| Number of pages | 7 |
| Journal | Archives of Ophthalmology |
| Volume | 127 |
| Issue number | 4 |
| DOIs | |
| State | Published - Apr 2009 |
| Externally published | Yes |
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- Ophthalmology
Cite this
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 journal › Article
}
TY - JOUR
T1 - Pegaptanib sodium for macular edema secondary to central retinal vein occlusion
AU - Wroblewski, John J.
AU - Wells, John A.
AU - Adamis, Anthony P.
AU - Buggage, Ronald R.
AU - Cunningham, Emmett T.
AU - Goldbaum, Mauro
AU - Guyer, David R.
AU - Katz, Barrett
AU - Altaweel, Michael M.
PY - 2009/4
Y1 - 2009/4
N2 - 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.
AB - 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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U2 - 10.1001/archophthalmol.2009.14
DO - 10.1001/archophthalmol.2009.14
M3 - Article
VL - 127
SP - 374
EP - 380
JO - JAMA Ophthalmology
JF - JAMA Ophthalmology
SN - 2168-6165
IS - 4
ER -