The purpose of a study was to evaluate the effect of monthly intravitreal Ranibizumab ( Lucentis ) on hard exudate ( HE ) area and the impact of hard exudate on visual acuity ( VA ) outcomes in diabetic macular edema ( DME ) patients using data from two phase III clinical trials.
Partecipants were adults with diabetic macular edema, baseline best-corrected visual acuity 20/40 to 20/320 Snellen equivalent, and central foveal thickness of gretaer than or equal to 275 microm.
Between the two studies, 759 patients with diabetic macular edema were randomized to receive monthly 0.3 or 0.5 mg intravitreal Ranibizumab ( Lucentis ) or sham injections.
Hard exudate area was assessed from color fundus stereophotographs both on an ordinal scale and using continuous estimates of areas within the Early Treatment Diabetic Retinopathy Study grid.
Data from 739 eyes were available for analysis. Mean baseline hard exudate area was similar across treatment groups, ranging from 0.65 to 0.82 mm2.
Through month 24, the percentage of eyes without hard exudate increased from 20.9% to 36.3% in the sham group and from 22.1% to 61.3% and 23.6% to 62.0% in the Ranibizumab 0.3-mg and 0.5-mg groups, respectively.
Resolution of hard exudate became apparent sometime after month 6 in Ranibizumab-treated eyes.
At baseline, there was no meaningful correlation between hard exudate and presence or absence of hard exudate.
After baseline, there also was no consistent correlation between presence or absence of hard exudate and change in visual acuity over time.
In this exploratory analysis, monthly intravitreal Ranibizumab resulted in significantly greater reduction of hard exudate area compared with sham ( P less than 0.0001 ).
In contrast to the rapid effects of Ranibizumab on macular edema, changes in hard exudate area were more gradual.
Contrary to prior expectations, the presence and area of hard exudate did not increase as diabetic macular edema resolved ( either in the Ranibizumab or sham groups ).
Importantly, baseline visual acuity was not correlated with presence of hard exudate, nor was the therapeutic benefit of Ranibizumab on visual acuity affected negatively by the presence of hard exudate.
These data suggest that in the context of intravitreal anti-vascular endothelial growth factor therapy, the presence of hard exudate is not a prognostic indicator of poor visual outcomes. ( Xagena )
Domalpally A et al, Ophthalmology 2015; Epub ahead of print