Diabetic retinopathy or eye disease is a common complication experienced by individuals with T1D, particularly after living with the disease for decades. Diabetic eye disease can progress through a number of stages with increasing severity ultimately leading to vision loss in some cases. Ranibizumab (trade name Lucentis), has now been approved for the treatment of diabetic macular edema, one form of advanced diabetic eye disease involving a swelling of the retina that can lead to severe vision loss. However, no drug is available to treat or prevent vision loss at an earlier stage of the eye disease process. As those with diabetic macular edema generally have some degree of background eye disease, the team conducting Phase III trials for ranibizumab have examined the clinical trial data to determine whether there was any effect of ranibizumab on background diabetic eye disease in the patients in their trials. They found both, at 2 years and 3 years after the study was initiated, that those patients treated with ranibizumab, as well as having better visual outcomes on a reading chart, showed less progression of their eye disease on the Early Treatment Diabetic Retinopathy Study severity scale, and were more likely to show regression (improvement) of their eye disease compared to those receiving placebo injections. In addition, fewer patients treated with ranibizumab developed more advanced forms of eye disease.
Ramifications for Individuals with T1D:
While a novel treatment (ranibizumab) has now been approved in the US and Europe for diabetic macular edema, no drug treatment is available for the treatment of earlier stage diabetic eye disease, which can ultimately lead to more advanced stages and vision loss. Preventing the progression of disease at this earlier stage currently relies only on good diabetes management. However, not everyone goes on to develop the more advanced stages or vision loss and ranibizumab treatment carries a small risk of side effects, and the treatment is expensive and burdensome. Therefore, it would not make sense to treat everyone with early stage disease with ranibizumab. If we could identify the patients most likely to progress to more severe disease, it might be beneficial to test the drug in this population.
JDRF was not involved directly in these studies, though did participate in other clinical trials of ranibizumab.
Investigators and Institutions:
Multiple investigators primarily from Johns Hopkins Medical Institution, University of Wisconsin, and Genentech Inc.
- Brown DM, Nguyen QD, and others. Long-term Outcomes of Ranibizumab Therapy for Diabetic Macular Edema: The 36-Month Results from Two Phase III Trials: RISE and RIDE. Ophthalmology. 2013 May 22. doi:pii: S0161-6420(13)00212-1. 10.1016/j.ophtha.2013.02.034. [Epub ahead of print].
- Ip MS, Domalpally A, and others. Long-term effects of ranibizumab on diabetic retinopathy severity and progression. Arch Ophthalmol. 2012 Sep 1;130(9):1145-52. doi: 10.1001/archophthalmol.2012.1043.
- Effects of Intranvitreal Ranibizumab on Diabetic Retinopathy Severity: 36 Month Data from the RISE and RIDE Phase III trials. Presentation at ARVO 2013 meeting. May 8th 2013