Aflibercept’s diabetic retinopathy benefits independent of blood glucose

VIENNA – The beneficial effects of aflibercept on diabetic eye disease are independent of how well blood glucose is being controlled at the start of treatment, according to a post hoc analysis of two randomized, phase III studies.

Intravitreal injection of 2 mg of aflibercept every month or every other month had similar effects on the primary endpoint of best-corrected visual acuity (BCVA) in more than 800 subjects with diabetic macular edema (DME) with central involvement. BCVA was assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) chart.

The mean change in BCVA from baseline to 1-year follow-up was increased by around 11 letters with aflibercept treatment regardless of which quartile of hemoglobin A_1c patients fit into at study entry. In contrast, patients treated with laser therapy appeared to have lessening benefit from treatment as baseline HbA_1c increased, with an improvement of 4.1 letters in the first to –0.3 letters in the fourth HbA1c quartiles.

Aflibercept-treated patients also experienced a significant decrease in central retinal thickness (CRT) compared with laser therapy. The mean change in CRT from baseline to 1 year was –201 micrometers in aflibercept-treated patients with a baseline HbA_1c of between 4.5% and less than 6.5% (quartile 1), and –195, –196, and –188 micrometers in patients with HbA1c levels of 6.7% to less than 7.4% (quartile 2), 7.4% to less than 8.6% (quartile 3), and 8.6% to 14.7% (quartile 4). Corresponding values for laser therapy were –102, –83, –69, and –43 micometers.

“The findings show that improvements achieved with intravitreal aflibercept over laser in anatomical and functional outcomes – best-corrected visual acuity and central retinal thickness – were robust and similar in patients even with variable systemic disease control at baseline,” said Dr. Oliver Zeitz of Bayer HealthCare, which sponsored the study and markets aflibercept (Eylea) in conjunction with Regeneron Pharmaceuticals.

“Furthermore, we could see in these trials, in the overall population, we could observe improvement in diabetic retinopathy severity scale, which may indicate that aflibercept is not only efficacious on treating DME but also has a potentially beneficial effect on the underlying diabetic retinopathy,” Dr. Zeitz added when presenting the findings at the annual meeting of the European Association for the Study of Diabetes.

VIVID-DME and VISTA-DME are two similarly designed, ongoing studies that are evaluating the efficacy and safety of intravitreal aflibercept injection for the treatment of DME versus laser photocoagulation. A total of 872 patients were randomized in both trials to receive aflibercept 2 mg every 4 or 8 weeks plus a sham laser treatment, or to macular laser photocoagulation plus sham intravitreal therapy.

Aflibercept is a vascular endothelial growth factor (VEGF) inhibitor especially formulated for injection into the eye. The rationale for using the drug is that it helps stop the growth of new blood vessels that will obscure visions if left unchecked. It also decreases vascular permeability in the eye by blocking VEGF-A and placental growth factor.

Intravitreal aflibercept is approved in the United States and the European Union and several other countries for the management of wet age-related macular degeneration and for macular edema after central retinal vein occlusion. The drug has also just received FDA approval for the treatment of DME, according to a Regeneron statement.

Safety is, of course, an important consideration, Dr. Zeitz said, adding that there was a similar overall incidence of ocular and nonocular adverse events. There was also no difference in ocular serious adverse events, including arterial thromboembolic events as defined by the Anti-Platelet Trialists’ Collaboration. There were no cases of endophthalmitis reported.

Dr. Zeitz and his coauthors are employees of Bayer HealthCare, which sponsored the VISTA- and VIVID-DME studies.

VIENNA – The beneficial effects of aflibercept on diabetic eye disease are independent of how well blood glucose is being controlled at the start of treatment, according to a post hoc analysis of two randomized, phase III studies.

Intravitreal injection of 2 mg of aflibercept every month or every other month had similar effects on the primary endpoint of best-corrected visual acuity (BCVA) in more than 800 subjects with diabetic macular edema (DME) with central involvement. BCVA was assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) chart.

The mean change in BCVA from baseline to 1-year follow-up was increased by around 11 letters with aflibercept treatment regardless of which quartile of hemoglobin A_1c patients fit into at study entry. In contrast, patients treated with laser therapy appeared to have lessening benefit from treatment as baseline HbA_1c increased, with an improvement of 4.1 letters in the first to –0.3 letters in the fourth HbA1c quartiles.

Aflibercept-treated patients also experienced a significant decrease in central retinal thickness (CRT) compared with laser therapy. The mean change in CRT from baseline to 1 year was –201 micrometers in aflibercept-treated patients with a baseline HbA_1c of between 4.5% and less than 6.5% (quartile 1), and –195, –196, and –188 micrometers in patients with HbA1c levels of 6.7% to less than 7.4% (quartile 2), 7.4% to less than 8.6% (quartile 3), and 8.6% to 14.7% (quartile 4). Corresponding values for laser therapy were –102, –83, –69, and –43 micometers.

“The findings show that improvements achieved with intravitreal aflibercept over laser in anatomical and functional outcomes – best-corrected visual acuity and central retinal thickness – were robust and similar in patients even with variable systemic disease control at baseline,” said Dr. Oliver Zeitz of Bayer HealthCare, which sponsored the study and markets aflibercept (Eylea) in conjunction with Regeneron Pharmaceuticals.

“Furthermore, we could see in these trials, in the overall population, we could observe improvement in diabetic retinopathy severity scale, which may indicate that aflibercept is not only efficacious on treating DME but also has a potentially beneficial effect on the underlying diabetic retinopathy,” Dr. Zeitz added when presenting the findings at the annual meeting of the European Association for the Study of Diabetes.

VIVID-DME and VISTA-DME are two similarly designed, ongoing studies that are evaluating the efficacy and safety of intravitreal aflibercept injection for the treatment of DME versus laser photocoagulation. A total of 872 patients were randomized in both trials to receive aflibercept 2 mg every 4 or 8 weeks plus a sham laser treatment, or to macular laser photocoagulation plus sham intravitreal therapy.

Aflibercept is a vascular endothelial growth factor (VEGF) inhibitor especially formulated for injection into the eye. The rationale for using the drug is that it helps stop the growth of new blood vessels that will obscure visions if left unchecked. It also decreases vascular permeability in the eye by blocking VEGF-A and placental growth factor.

Intravitreal aflibercept is approved in the United States and the European Union and several other countries for the management of wet age-related macular degeneration and for macular edema after central retinal vein occlusion. The drug has also just received FDA approval for the treatment of DME, according to a Regeneron statement.

Safety is, of course, an important consideration, Dr. Zeitz said, adding that there was a similar overall incidence of ocular and nonocular adverse events. There was also no difference in ocular serious adverse events, including arterial thromboembolic events as defined by the Anti-Platelet Trialists’ Collaboration. There were no cases of endophthalmitis reported.

Dr. Zeitz and his coauthors are employees of Bayer HealthCare, which sponsored the VISTA- and VIVID-DME studies.

VIENNA – The beneficial effects of aflibercept on diabetic eye disease are independent of how well blood glucose is being controlled at the start of treatment, according to a post hoc analysis of two randomized, phase III studies.

Intravitreal injection of 2 mg of aflibercept every month or every other month had similar effects on the primary endpoint of best-corrected visual acuity (BCVA) in more than 800 subjects with diabetic macular edema (DME) with central involvement. BCVA was assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) chart.

The mean change in BCVA from baseline to 1-year follow-up was increased by around 11 letters with aflibercept treatment regardless of which quartile of hemoglobin A_1c patients fit into at study entry. In contrast, patients treated with laser therapy appeared to have lessening benefit from treatment as baseline HbA_1c increased, with an improvement of 4.1 letters in the first to –0.3 letters in the fourth HbA1c quartiles.

Aflibercept-treated patients also experienced a significant decrease in central retinal thickness (CRT) compared with laser therapy. The mean change in CRT from baseline to 1 year was –201 micrometers in aflibercept-treated patients with a baseline HbA_1c of between 4.5% and less than 6.5% (quartile 1), and –195, –196, and –188 micrometers in patients with HbA1c levels of 6.7% to less than 7.4% (quartile 2), 7.4% to less than 8.6% (quartile 3), and 8.6% to 14.7% (quartile 4). Corresponding values for laser therapy were –102, –83, –69, and –43 micometers.

“The findings show that improvements achieved with intravitreal aflibercept over laser in anatomical and functional outcomes – best-corrected visual acuity and central retinal thickness – were robust and similar in patients even with variable systemic disease control at baseline,” said Dr. Oliver Zeitz of Bayer HealthCare, which sponsored the study and markets aflibercept (Eylea) in conjunction with Regeneron Pharmaceuticals.

“Furthermore, we could see in these trials, in the overall population, we could observe improvement in diabetic retinopathy severity scale, which may indicate that aflibercept is not only efficacious on treating DME but also has a potentially beneficial effect on the underlying diabetic retinopathy,” Dr. Zeitz added when presenting the findings at the annual meeting of the European Association for the Study of Diabetes.

VIVID-DME and VISTA-DME are two similarly designed, ongoing studies that are evaluating the efficacy and safety of intravitreal aflibercept injection for the treatment of DME versus laser photocoagulation. A total of 872 patients were randomized in both trials to receive aflibercept 2 mg every 4 or 8 weeks plus a sham laser treatment, or to macular laser photocoagulation plus sham intravitreal therapy.

Aflibercept is a vascular endothelial growth factor (VEGF) inhibitor especially formulated for injection into the eye. The rationale for using the drug is that it helps stop the growth of new blood vessels that will obscure visions if left unchecked. It also decreases vascular permeability in the eye by blocking VEGF-A and placental growth factor.

Intravitreal aflibercept is approved in the United States and the European Union and several other countries for the management of wet age-related macular degeneration and for macular edema after central retinal vein occlusion. The drug has also just received FDA approval for the treatment of DME, according to a Regeneron statement.

Safety is, of course, an important consideration, Dr. Zeitz said, adding that there was a similar overall incidence of ocular and nonocular adverse events. There was also no difference in ocular serious adverse events, including arterial thromboembolic events as defined by the Anti-Platelet Trialists’ Collaboration. There were no cases of endophthalmitis reported.

Dr. Zeitz and his coauthors are employees of Bayer HealthCare, which sponsored the VISTA- and VIVID-DME studies.