Table 1.
Major design characteristics and findings from the pivotal Phase II and III ranibizumab trials for the treatment of diabetic macular edema
| Study name | Study design | Major outcomes |
|---|---|---|
| READ-2 | Three treatment arms: ranibizumab 0.5 mg laser ranibizumab and laser |
Change in VA (letters) at 6 months: +7.24, −0.43, +3.8 ≥15 letter improvement: 22%, 0%, 8% |
| RESOLVE | Three treatment arms: ranibizumab 0.3 mg ranibizumab 0.5 mg sham (rescue laser allowed at 3 months) (dose doubling allowedat 1 month) |
Change in VA (letters) at 1 year: + 10.3 (ranibizumab) +1.4 (sham) CRT improved by: −194.2 μ m (ranibizumab) −48.4 μ m (sham) |
| RESTORE | Three treatment arms: ranibizumab ranibizumab + laser laser |
Change in VA (letters) at 1 year: +6.8, +6.4, +0.9 ≥15 letter improvement: 22.6%, 22.9%, 8.2% Average improvements in CRT: −118 μ m, −128 μ m, −61 μ m |
| DRCR.net Protocol I |
Four treatment arms: ranibizumab + prompt laser ranibizumab + delayed laser triamcinolone + laser sham injection + laser |
Change in VA (letters) at 1 year: +9, +9, +4, +3 Change in VA (letters) at 2 years versus sham +3.7, +5.8, −1.5 Subset analysis: pseudophakic eyes with triamcinolone + laser similar to ranibizumab groups |
| RISE and RIDE | 24-month trials Three treatment arms: sham ranibizumab 0.3 mg or 0.5 mg (rescue laser allowedat 3 months) |
≥15 letter improvement: 18.1%, 44.8%, and 39.2% (RISE) 12.3%, 33.6%, and 33.3% (RIDE) Average vision improvement (letters) +10.9 to +12.5 (ranibizumab) +2.3 and +2.6 (sham) |
Abbreviations: CRT, central retinal thickness; VA, visual acuity; READ-1, Ranibizumab for Edema of the mAcula in Diabetes; RESOLVE, Safety and Efficacy of Ranibizumab in Diabetic Macular Edema with Center involvement; RESTORE, A 12 Month Core Study to Assess the Efficacy and Safety of Ranibizumab Intravitreal injections; RISE, A Study of Ranibizumab injection in Subjects With Clinically Significant Macular Edema With Center Involvement Secondary to Diabetes Mellitus; RIDE, A Study of Ranibizumab Injection in Subjects With Clinically Significant Macular Edema With Center involvement Secondary to Diabetes Mellitus; DRCR. net, Diabetic Retinopathy Clinical Research Network.