Can Ozempic (semaglutide) be used in patients with diabetic (DM) retinopathy?

Semaglutide (Ozempic) Use in Patients with Diabetic Retinopathy

Semaglutide can be used in patients with diabetic retinopathy, but caution is warranted, particularly in those with a history of proliferative retinopathy, as it may increase the risk of retinopathy complications.

Risk Assessment and Monitoring Recommendations

Patient Risk Stratification

• Low risk: Patients with no history of diabetic retinopathy
• Moderate risk: Patients with mild to moderate non-proliferative diabetic retinopathy
• High risk: Patients with:
  • History of proliferative retinopathy
  • Pre-existing severe non-proliferative retinopathy
  • Recent rapid improvement in glycemic control

Required Pre-Treatment Evaluation

• Recent comprehensive eye examination (within past 3-6 months) 1, 2
• Baseline documentation of retinopathy status
• Assessment of other risk factors:
  • Duration of diabetes (≥10 years increases risk) 3
  • Age (≥60 years increases risk) 3
  • Poor baseline glycemic control
  • Insulin use

Evidence-Based Guidance

FDA Label Information

The FDA label for semaglutide (Ozempic) specifically addresses diabetic retinopathy:

• In a 2-year trial, more events of diabetic retinopathy complications occurred in patients treated with Ozempic (3.0%) compared to placebo (1.8%) 2
• The absolute risk increase was larger among patients with a history of diabetic retinopathy at baseline (Ozempic 8.2%, placebo 5.2%) compared to those without (Ozempic 0.7%, placebo 0.4%) 2

Clinical Practice Guidelines

The American College of Cardiology notes:

• An increased risk of diabetic retinopathy complications has been observed with semaglutide, predominantly in patients with prior history of proliferative retinopathy 1
• The risks and benefits of semaglutide therapy should be carefully considered in these patients 1
• Patients should have a recent eye examination prior to semaglutide initiation 1

Management Algorithm

1. For patients without pre-existing retinopathy:

   • Proceed with semaglutide therapy
   • Schedule routine eye examinations as recommended for all diabetic patients (annually)
   • Monitor for symptoms of visual changes

2. For patients with non-proliferative retinopathy:

   • Obtain baseline eye examination before starting therapy
   • Proceed with semaglutide with more frequent monitoring (every 3-6 months)
   • Consider slower titration of semaglutide to avoid rapid glucose reduction

3. For patients with history of proliferative retinopathy:

   • Carefully weigh benefits versus risks
   • Consider alternative GLP-1 receptor agonists if appropriate
   • If proceeding with semaglutide:
     • Ensure close ophthalmologic follow-up (every 3 months)
     • Use slower dose titration schedule
     • Monitor for visual symptoms and retinopathy progression

Important Clinical Considerations

Mechanism of Retinopathy Risk

The increased risk of retinopathy complications with semaglutide is hypothesized to be due to rapid and sustained reductions in blood glucose rather than a direct effect on the retina 1. This phenomenon has been observed with intensive insulin therapy and is not unique to semaglutide.

Balancing Benefits and Risks

For most patients, the cardiovascular and metabolic benefits of semaglutide likely outweigh the potential retinal risks 4. The absolute risk increase is modest in patients without pre-existing retinopathy (0.3%) 2.

Common Pitfalls to Avoid

1. Failing to obtain baseline eye examination: Always ensure patients have had a recent eye exam before starting semaglutide 1, 2
2. Overly rapid glucose reduction: Consider slower dose titration in high-risk patients to avoid sudden glycemic improvement
3. Inadequate follow-up: Establish appropriate ophthalmologic monitoring based on baseline retinopathy status
4. Ignoring symptoms: Educate patients to report any visual changes promptly

Recent Evidence and Emerging Data

Meta-analyses show mixed results regarding semaglutide and retinopathy risk:

• A 2022 meta-analysis of 23 randomized trials found that overall, semaglutide was not associated with increased diabetic retinopathy risk compared with controls (RR 1.14,95% CI 0.98-1.33) 3
• However, subgroup analysis showed increased risk compared specifically to placebo (RR 1.24,95% CI 1.03-1.50) 3
• Patient age ≥60 years and diabetes duration ≥10 years were identified as risk factors for increased retinopathy when using semaglutide 3

Interestingly, there are also case reports suggesting potential benefits of semaglutide in some patients with diabetic retinopathy, including one case showing resolution of proliferative diabetic retinopathy following semaglutide treatment 5.

Dedicated safety studies for semaglutide in diabetic retinopathy are currently underway to provide more definitive guidance 4.