Key Findings
- The prophylactic administration of Eylea (aflibercept) injections over 2 years was associated with a reduced risk of developing vision-threatening complications seen in diabetes mellitus.
- Contrastingly, the prophylactic administration of Eylea did not confer any visual acuity benefit for patients with diabetes.
Retina
Diabetes mellitus, a condition characterised by an elevated blood glucose level greater than 126 mg/dl, is a very common disease, especially in the United States. This disease is commonly associated with a few complications, especially when it remains untreated or poorly treated. Two of these complications are proliferative diabetic retinopathy (PDR) and center-involved diabetic macular edema (CI-DME) with vision loss. Unfortunately, however, like many conditions that affect the human eye, people with these complications have a higher risk of losing their vision.
Before now, studies have shown that the administration of drugs known as anti-vascular endothelial growth factors (VEGF) was effective in treating both conditions. Because this treatment involves the administration of these drugs into the vitreous, a fluid-filled space inside the eye, it is known as intravitreous drug administration. However, in a recent study by Raj Maturi and his colleagues, it was discovered that these drugs may be useful even as prophylaxis against both conditions.
What Did The Study Involve?
The study, which was published in JAMA Ophthalmology, evaluated the efficacy of early treatment with intravitreal aflibercept (also known as Eylea) injections compared to sham treatment in preventing vision-threatening complications in patients with diabetes.
For this study, the researchers enrolled 328 participants (aged 18 years and above) who had either type 1 or type 2 diabetes and the severe form of a condition known as nonproliferative diabetic retinopathy. This selection process was determined by the investigators and was conducted across 64 clinical sites within the United States and Canada. The study itself spanned from January 2016 to May 2020, hence, only data collected during this time was considered.
After the consenting participants were enrolled, the researchers randomly split them into 2 groups. While members in one group would receive 2 mg of intravitreal aflibercept (Eylea), members in the other group would be given sham injections— a simulated procedure that mimicked a real injection but without administering any medication, to serve as a placebo. Participants with 2 study eyes were randomly assigned to receive aflibercept in one eye and a sham injection in the other.
Notably, the treatments were administered at the study (or baseline). Thereafter, the drugs were administered monthly for the next two months. After this, the drugs were given on the 4th month of the study. Following this, however, the participants were scheduled to receive treatments every 4 months for 4 years.
The study itself aimed to investigate the risk of the development of CI-DME with vision loss or PDR in patients with NPDR.
Intravitreal Administration Of Eylea Is Associated With A Lower Risk Of Developing PDR and CI-DME
By March 2018, two years following the start of the study, the researchers observed that participants who received Eylea were less likely to develop CI-DME with vision loss or PDR. This was demonstrated in the fact that the development rate of PDR in the Eylea and sham groups were 13.5% and 33.2%, respectively. Similarly, while 14.8% of participants in the sham group ended up developing CI-DME with vision loss, only 4.1% of participants in the Eylea group ended up with this complication. This suggested that the administration of Eylea may have some prophylactic effect against both conditions in the participants.
While the results are promising, the use of Eylea as a preventative measure is not yet part of standard clinical guidelines. Factors such as cost, treatment burden (e.g., frequent injections), and the lack of long-term benefit on visual acuity remain barriers to widespread prophylactic use.
Intravitreal Administration of Eylea Did Not Improve Visual Acuity In Patients With Diabetic Retinopathy
On the other hand, although the researchers recorded that after 2 years of treatment, 120 of the 160 eyes receiving Eylea had a visual acuity of 20/20 or better, in contrast to 119 out of 166 in the sham group, they reported that this finding was not statistically significant.
FAQS
How does Eylea work in preventing diabetic retinopathy complications?
Eylea (aflibercept) is an anti-vascular endothelial growth factor (VEGF) drug. This means that it prevents the action of VEGF. When released in diabetic retinopathy, VEGF causes abnormal growth of blood vessels and leakage of their contents into the retina, thereby damaging it. Therefore, by blocking this agent, this study suggests that Eylea may be useful in reducing the risk of vision-threatening complications like proliferative diabetic retinopathy (PDR) and center-involved diabetic macular edema (CI-DME) with vision loss.
Are there any side effects of using Eylea?
Yes, like any medication, Eylea has potential side effects. Common ones include eye pain, floaters, increased intraocular pressure, and inflammation. More serious but rare side effects may include retinal detachment, eye infections, or arterial thromboembolic events.
Is Eylea covered by insurance when used preventively?
Currently, most insurers cover Eylea for active disease but not for prophylactic use, unless strong clinical justification is provided. This could change as more studies are published.
Related Reading:
Blindness: Reactivating Inactive Genes Can Regenerate Damaged Retinas
A Brain Implant May Be Used to Restore Basic Vision in the Blind
Final Thoughts
The findings of this study point to a possible application of Eylea (aflibercept) in the prevention of proliferative diabetic retinopathy or center-involved diabetic macular edema with vision loss. Before now, this drug, as well as others in its family, has only been used to treat both conditions. However, it is important to note that further research would be required to address a few gray areas regarding its use before it can become a recommended drug to prevent both conditions.
For example, because this study considered only aflibercept, its findings may not apply to other drugs, even though they are also anti-VEGF drugs. Also, owing to mortalities during the study period (20% and 16% in the Eylea and sham groups, respectively), some participants did not complete the study. This could have affected the results
References
Maturi, R. K., Glassman, A. R., Josic, K., Antoszyk, A. N., Blodi, B. A., Jampol, L. M., Marcus, D. M., Martín, D., Melia, M., Hani Salehi-Had, Stockdale, C. R., Punjabi, O. S., & Sun, J. K. (2021). Effect of Intravitreous Anti–Vascular Endothelial Growth Factor vs Sham Treatment for Prevention of Vision-Threatening Complications of Diabetic Retinopathy. JAMA Ophthalmology, 139(7), 701–712. https://doi.org/10.1001/jamaophthalmol.2021.0606
National Institutes of Health. (2021, March 31). Preventive treatment reduces diabetic retinopathy complications. https://www.nih.gov/news-events/news-releases/preventive-treatment-reduces-diabetic-retinopathy-complications
FEEDBACK:
