The efficacy and safety profile of ranibizumab in patients with central retinal vein occlusion (CRVO) is well established, but to date, real-world evidence has been limited to specific regions, countries or small patient populations. LUMINOUS, a five-year investigation conducted at 488 clinical sites across 42 countries found ranibizumab 0.5 mg treatment improved visual outcomes in treatment naïve CRVO patients at one year, and the researchers identified no new safety findings at year five.
The investigation recruited treatment naïve or prior medicated patients with CRVO who were given ranibizumab. CRVO participants were roughly 69 years old, with a VA of 40.6 letters at baseline. A total of 30,138 patients were enrolled across all five approved indications (wet AMD, diabetic macular edema, branch RVO, CRVO and myopic choroidal neovascularization) in the overall LUMINOUS trial. Of the total population, 1,048 (3.5%) patients had CRVO, of whom 327 (31.2%) were treatment naïve.
Of the total treatment-naïve patients, 249 remained in the study until the end of year one, and 171 completed the investigation, which ran from 2011 to 2016.
Key study highlights included:
- At year one, 144 patients gained 10.8 letters, based on 5.4 ranibizumab injections.
- Patients had VA gains of 2.7, 11.6, 13.9, 11.1 and 8.2 letters with one, two to three, four to five, six to eight and more than eight ranibizumab injections, respectively.
- VA gains at one year in patients receiving loading (67.4%) and no loading dose (32.6%) were 11.9 and 8.4 letters, respectively. Over five years, the incidence of ocular/non-ocular adverse events and serious adverse events was 11.3%/8.6% and 1.2%/6.7%, respectively.
- There were no new safety signals identified, and the safety profile was consistent with the known safety profile of ranibizumab.
Across all participating countries, the study identified a similar pattern of patients who achieved better VA outcomes: those with a low baseline VA, had a higher numbers of ranibizumab injections or were treated with an adequate loading dose.
These findings may help inform routine practice and enable better clinical management to achieve optimal visual outcomes, the authors noted.
Lotery A, Clemens A, Tuli R, et al. Effectiveness and safety of ranibizumab in patients with central retinal vein occlusion: results from the real-world, global, LUMINOUS study. Eye (Lond). July 29, 2021. [Epub ahead of print].