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Rishi P Singh, Lisa Tuomi, Ivaylo Stoilov; The top 10 findings from the RIDE/RISE trials of ranibizumab in patients with diabetic macular edema. Invest. Ophthalmol. Vis. Sci. 201657(12):.
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© ARVO (1962-2015); The Authors (2016-present)
To summarize key clinically relevant lessons from 5 years of experience with ranibizumab (RBZ) in the treatment of diabetic macular edema (DME) and diabetic retinopathy (DR) in the RIDE and RISE phase 3 trials.
RIDE and RISE were randomized phase 3 trials enrolling patients with DME (N=759) to receive monthly RBZ (0.3 mg or 0.5 mg) or sham injections for 24 months. From month 25 to 36, patients randomized to RBZ continued monthly injections of their original dose, whereas patients in the sham arm crossed over to monthly 0.5 mg RBZ. After month 36, 500 patients elected to enter an open-label extension (OLE) study in which they received 0.5 mg RBZ pro re nata (PRN) based on prespecified worsening of vision or edema criteria.
1) RBZ resulted in rapid, significant, and sustained improvement of retinal thickness and vision. 2) Prior treatment with laser and/or steroids did not affect these outcomes. 3) Baseline characteristics such as HbA1c and posterior retinal nonperfusion did not affect visual acuity outcomes with RBZ; however, 4) deferral of treatment for 2 years resulted in less vision gain. 5) RBZ treatment resulted in rapid improvements in DR (significant 2-step improvement as early as 3 months, and 3-step as early as 12 months). Notably, >75% of RBZ-treated patients with moderately severe or severe nonproliferative DR experienced ≥2-step DR improvements as early as month 12. 6) RBZ delayed the time to vitreous hemorrhage and panretinal photocoagulation, and 7) significantly reduced the area of hard exudates in eyes with DME. 8) Patients who required cataract surgery during RIDE/RISE experienced a mean of ≥10-letter improvement 1 month after surgery. 9) When patients switched to less-than-monthly therapy in the OLE, mean vision and retinal thickness improvements were maintained with a mean of 3.8 annualized injections; ~25% of patients required no further injections to maintain these outcomes. 10) Improvements in DR were also durable with PRN injection.
In RIDE and RISE, RBZ treatment resulted in clinically relevant improvements in vision and retinal thickness regardless of baseline characteristics or previous treatment. RBZ also resulted in improvements in DR, particularly in patients at high risk of progression to proliferative DR. Improvements were maintained with less-than-monthly treatment.
This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.
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