Review Article

Vascular Complications and Diabetes: Current Therapies and Future Challenges

Table 2

Clinical trials of anti-VEGF pharmaceuticals for diabetic macular edema.

Drug/interventionStatus/paperDesignNFollow-upPopulationAuthor conclusions

Intravitreal pegaptanib versus sham injectionsCunningham Jr. et al. [28]Randomized; double masked; Dose-ranging; controlled17236 weeksCenter involving DME, VA 20/50–20/320Pegaptanib group had better VA, reduction in CRT, and less likely to need photocoagulation at followup

Intravitreal pegaptanib versus sham injectionsSultan et al. [29]Randomized; sham controlled; multicenter; parallel group260 in year 1 207 in year 22 yearsCenter involving DMEPegaptanib offers clinical benefit for patients with DME: better VA, reduced CRT

Comparing laser alone, laser with intravitreal triamcinolone, laser with intravitreal ranibizumab, and intravitreal ranibizumab aloneActive, no publication (NCT00444600)Randomized; double masked; parallel assignment; four treatment arms69122 months Center involving DMEResults not yet published

ranibizumab versus nontreatmentMassin et al. [30] (RESOLVE)Randomized; double masked; parallel assignment10012 monthsCenter involving DMERanibizumab is effective in improving BCVA and is well tolerated in DME

Ranibizumab with laser versus laser aloneMitchell et al. [31] (RESTORE)Randomized; double Masked; laser controlled; multicenter34512 monthsType 1 and 2 diabetic patients with visual impairment due to DMECombined therapy provided superior VA gain. No difference detected at 1 year

Ranibizumab versus laserActive, no publication (LUCIDATE) (NCT01223612)Randomized; open label; parallel assignment4048 weeksType 1 and type 2 diabetic patients with DMEResults not yet published

Intravitreal injection on bevacizumab (4 doses) versus focal photocoagulationScott et al. [32]Randomized; partially masked; five treatment arms12124 weeksCenter involving DMEPromising data warranting a phase III trial

Intravitreal bevacizumab versus triamcinoloneCompleted, no publication (NCT01342159)Randomized; single blind; parallel assignment; three treatment arms8020 monthsCenter involving DMEResults not yet published

Intravitreal bevacizumab dose comparisonLam et al. [33]Randomized; dose ranging5262 weeksDiffuse, center involving DMEBoth treatment arms were associated with similar reduced CRT and increased BCVA

Intravitreal bevacizumab alone or in combination with intravitreal triamcinolone versus macular laser photocoagulationSoheilian et al. [34]Randomized; double masked; three treatment arms15024 weeksClinically significant DMEBevacizumab arm yielded a better visual outcome versus photocoagulation

This list, while comprehensive, is not exhaustive. Current clinical trial information can be found at http://www.clinicaltrials.gov/
N: Number of eyes; DME: diabetic macular edema; VA: visual Acuity; CRT: central retinal thickness; BCVA: best corrected visual acuity.