OBJECTIVE: To evaluate effects of intravitreal ranibizumab on diabetic retinopathy (DR) severity over time in 2 phase 3 clinical trials (RIDE, NCT00473382; RISE, NCT00473330) of ranibizumab for diabetic macular edema. METHODS:Participants with diabetic macular edema (n=759) were randomized to monthly sham, 0.3-mg ranibizumab, or 0.5-mg ranibizumab intravitreal injections. Macular laser was available per protocol-specified criteria. Fundus photographs, taken at baseline and periodically, were graded by a central reading center; clinical examinations were performed monthly. The main outcome measures of this report are secondary/exploratory analyses including a 2-step or more and 3-step or more change on the Early Treatment Diabetic Retinopathy Study severity scale in the study eye and a composite DR progression outcome including photographic changes plus clinically important events such as occurrence of vitreous hemorrhage or need for panretinal laser. RESULTS: At 2 years, the percentage of participants with DR progression (worsening by ≥ 2 or ≥ 3 steps) was significantly reduced in ranibizumab-treated eyes compared with sham-treated eyes, and DR regression (improving by ≥ 2 or ≥ 3 steps) was significantly more likely. The cumulative probability of clinical progression of DR as measured by the composite outcome at 2 years was 33.8% of sham-treated eyes compared with 11.2% to 11.5% of ranibizumab-treated eyes. CONCLUSIONS:Intravitreal ranibizumab reduced the risk of DR progression in eyes with diabetic macular edema, and many ranibizumab-treated eyes experienced improvement in DR severity. Because these results are exploratory, the use of intravitreal ranibizumab specifically to reduce DR progression or cause DR regression requires further study.
RCT Entities:
OBJECTIVE: To evaluate effects of intravitreal ranibizumab on diabetic retinopathy (DR) severity over time in 2 phase 3 clinical trials (RIDE, NCT00473382; RISE, NCT00473330) of ranibizumab for diabetic macular edema. METHODS:Participants with diabetic macular edema (n=759) were randomized to monthly sham, 0.3-mg ranibizumab, or 0.5-mg ranibizumab intravitreal injections. Macular laser was available per protocol-specified criteria. Fundus photographs, taken at baseline and periodically, were graded by a central reading center; clinical examinations were performed monthly. The main outcome measures of this report are secondary/exploratory analyses including a 2-step or more and 3-step or more change on the Early Treatment Diabetic Retinopathy Study severity scale in the study eye and a composite DR progression outcome including photographic changes plus clinically important events such as occurrence of vitreous hemorrhage or need for panretinal laser. RESULTS: At 2 years, the percentage of participants with DR progression (worsening by ≥ 2 or ≥ 3 steps) was significantly reduced in ranibizumab-treated eyes compared with sham-treated eyes, and DR regression (improving by ≥ 2 or ≥ 3 steps) was significantly more likely. The cumulative probability of clinical progression of DR as measured by the composite outcome at 2 years was 33.8% of sham-treated eyes compared with 11.2% to 11.5% of ranibizumab-treated eyes. CONCLUSIONS: Intravitreal ranibizumab reduced the risk of DR progression in eyes with diabetic macular edema, and many ranibizumab-treated eyes experienced improvement in DR severity. Because these results are exploratory, the use of intravitreal ranibizumab specifically to reduce DR progression or cause DR regression requires further study.
Authors: Jeffrey G Gross; Adam R Glassman; Lee M Jampol; Seidu Inusah; Lloyd Paul Aiello; Andrew N Antoszyk; Carl W Baker; Brian B Berger; Neil M Bressler; David Browning; Michael J Elman; Frederick L Ferris; Scott M Friedman; Dennis M Marcus; Michele Melia; Cynthia R Stockdale; Jennifer K Sun; Roy W Beck Journal: JAMA Date: 2015-11-24 Impact factor: 56.272
Authors: Raquel Lima E Silva; Yogita Kanan; Adam C Mirando; Jayoung Kim; Ron B Shmueli; Valeria E Lorenc; Seth D Fortmann; Jason Sciamanna; Niranjan B Pandey; Jordan J Green; Aleksander S Popel; Peter A Campochiaro Journal: Sci Transl Med Date: 2017-01-18 Impact factor: 17.956
Authors: Seong Hun Jeong; Jung Il Han; Sung Won Cho; Dong Won Lee; Chul Gu Kim; Tae Gon Lee; Jong Woo Kim Journal: Int J Ophthalmol Date: 2016-10-18 Impact factor: 1.779
Authors: Susan B Bressler; Danni Liu; Adam R Glassman; Barbara A Blodi; Alessandro A Castellarin; Lee M Jampol; Paul L Kaufman; Michele Melia; Harinderjit Singh; John A Wells Journal: JAMA Ophthalmol Date: 2017-06-01 Impact factor: 7.389
Authors: Hisanori Imai; Gauri P Misra; Linfeng Wu; Dileep R Janagam; Thomas W Gardner; Tao L Lowe Journal: Invest Ophthalmol Vis Sci Date: 2015-12 Impact factor: 4.799