Duration 5min, Q&A 3min
Ranibizumab Monotherapy or Combined with Laser Versus Laser in Asian Patients with Visual Impairment Due to DME: Subgroup Analysis of Best-Corrected Visual Acuity by Baseline Characteristics from the REVEAL Study
The primary endpoint of the Phase III REVEAL (Ranibizumab in the trEatment of Visual impairment in diabEtic mAcuLar edema) study demonstrated that ranibizumab monotherapy or combined with laser had superior best-corrected visual acuity (BCVA) improvements up to Month 12 over laser monotherapy in Asian patients with visual impairment due to diabetic macular edema (DME). Subgroups with selected baseline characteristics were analyzed to assess their influence on BCVA outcomes and to compare the treatment groups.
A 12-month, Phase III, multicenter, double-masked, laser-controlled study in which patients (N=396) were randomized 1:1:1 to Group-I (ranibizumab + sham laser, n=133), Group-II (ranibizumab + active laser, n=132), and Group-III (sham injection + active laser, n=131).
BCVA outcomes were analyzed for the following subgroups: age (<65/≧65 years), gender (males/females), baseline BCVA (≦60/61-73/>73 letters), DME types (focal/diffuse), prior focal and/or grid laser treatment (yes/no), baseline early treatment diabetic retinopathy study (ETDRS) severity scores (10-35/43 or 47/ 53-85), baseline macular ischemia (yes/no), and diabetes types (Types I/II). Main outcome measure was mean average change in BCVA from baseline to Month 1 through Month 12.
Results and Conclusion
aData for all subgroups are presented in sequence of Group-I/II/III. Numerically greater mean average BCVA improvement from baseline to Month 1-12 were found in all subgroups of ranibizumab (monotherapy or combined with laser) versus laser for age (<65 years: 6.1/6.1/1.5 and ≧65 years: 5.4/4.9/1.2 letters), gender (males: 5.6/6.3/1.3 and females: 6.3/5.1/1.5 letters), baseline BCVA (≦60 letters: 6.9/7.0/2.6, 61-73 letters: 5.3/4.1/-0.2 and >73 letters: 2.1/3.0/-0.5 letters), DME types (focal: 4.5/6.1/1.9 and diffuse: 6.2/5.7/1.0 letters); prior focal and/or grid laser treatment (yes/no: 5.5/6.4/1.1; 6.0/5.4/1.5 letters); baseline ETDRS severity scores (10-35: 2.6/1.7/3.3; 43 or 47: 5.0/6.1/1.2; 53-85: 6.7/5.3/1.4 letters), and baseline macular ischemia (yes: 5.8/7.1/0.6 and no: 6.2/5.8/1.7 letters). Patients with lower baseline BCVA and patients with higher ETDRS severity scores benefitted more in all treatment groups, while numerically higher letter gain was observed with ranibizumab therapy (monotherapy or combined with laser) versus laser.
Regardless of the baseline characteristics analyzed, the BCVA outcomes from all the subgroups were in accordance with the primary analysis of the REVEAL study. Lower baseline BCVA and higher ETDRS severity scores may possibly be associated with better BCVA gains. The results from the REVEAL study conducted in Asian patients corroborate the results of the RESTORE study conducted in Caucasian patients.
[ Keyword ]
REVEAL / Ranibizumab / Diabetic macular edema / Laser / Asian patients
[ Conflict of Interest ]
[ Conflict of Interest (Potential conflict) ]
Masahito Ohji is a consultant for Alcon, Bayer, Novartis, Shionogi, Sanwa kagaku, and Santen, and he receives honoraria from Alcon, Bayer, Novartis, Shionogi, Sanwa kagaku, Santen, HOYA, Senju, Kowa, and MSD.
Tatsuro Ishibashi is a cosultant and recipient for Alcon, Aqua Therapeutics, Bausch & Lomb, Bayer, GlaxoSmithKline, Novartis, Pfizer, Santen, Sanwa Kagaku, and Wakamoto. He is also a consultant for Allergan, Astellas, and Shionogi and a recipient for AMO Japan, Aqumen Biopharma, Chuo Sangio, Hoya, Kowa, MSD, Nidek, Otsuka, Rohto, Senju, and Sun Contact Lens.