Intravitreal bevacizumab can reduce diabetic macular oedema (DME) in some eyes, but a Phase III trial is required to determine whether the treatment is beneficial in the long-term.
Intravitreal bevacizumab can reduce diabetic macular oedema (DME) in some eyes, but a Phase III trial is required to determine whether the treatment is beneficial in the long-term, according to the results of a study published in the August issue of Ophthalmology.
The Diabetic Retinopathy Clinical Research Network conducted a randomized, Phase II clinical trial to assess the short-term effect of intravitreal bevacizumab for DME. A total of 109 subjects with DME and Snellen acuity equivalent ranging from 20/32 to 20/320 were enrolled.
The subjects were randomized into three groups: (A) focal photocoagulation at baseline (n=19); (B) intravitreal injection of 1.25 mg of bevacizumab at baseline and six weeks (n=22); (C) intravitreal injection of 2.5 mg of bevacizumab at baseline and six weeks (n=24); (D) intravitreal injection of 1.25 mg of bevacizumab at baseline and sham injection at six weeks (n=22) or (E) intravitreal injection of 1.25 mg of bevacizumab at baseline and six weeks with photocoagulation at three weeks (n=22).
At baseline, median central subfield thickness (CST) was 411 µm and median Snellen visual acuity (VA) equivalent was 20/50. Groups B and C had a greater reduction in CST at three weeks and a one line better median VA over 12 weeks than Group A. A CST reduction >11% was present at three weeks in 36 of 84 (43%) bevacizumab-treated eyes and five of 18 (28%) eyes treated with laser alone and at six weeks in 37% and 50% of eyes, respectively.
Combining focal photocoagulation with bevacizumab resulted in no apparent short-term benefits or adverse outcomes. Endophthalmitis developed in one eye, myocardial infarction in two patients, congestive heart failure in one patient, elevated blood pressure in three patients and worsened renal function in three patients.
The results demonstrate that bevacizumab can be effective in the treatment of DME in the short-term but a Phase III clinical study is required to determine whether it remains so in the long-term.