Intravitreal anti-VEGF improves vision in diabetic macular edema patients

Ophthalmology. 2011;118(6):1107-1118.

Intravitreal pegaptanib resulted in significantly improved vision in patients with diabetic macular edema, making it an effective, well-tolerated treatment option, a study found.

"These findings indicate that intravitreal pegaptanib is effective in the treatment of DME and, taken together with prior study data, support a positive safety profile in this population," the authors said.

The sham-controlled, multicenter, parallel-group phase 2/3 trial included a total of 467 patients.

In the first year, 133 patients received Macugen 0.3 mg (pegaptanib, Eyetech/Pfizer) and 127 patients received sham injections every 6 weeks for a total of nine injections. Patients could also receive focal/grid photocoagulation starting at week 18. In the second year, 107 patients received pegaptanib injections and 100 patients received sham injections as often as every 6 weeks.

At week 54, visual acuity improvement of at least 10 letters was observed in 49 (36.8%) of the pegaptanib-treated patients and 25 (19.7%) of the sham-treated patients in the first-year group (P = .0047). At week 102, pegaptanib-treated patients gained an average of 6.1 letters compared with sham-treated patients who gained 1.3 letters (P < .01).

In addition, fewer pegaptanib-treated patients than sham-treated patients required focal/grid photocoagulation at both week 54 and week 102, according to the study.

Pegaptanib-treated patients also had significantly better results on the National Eye Institute Visual Functioning Questionnaire.