Summary:
In adults with diabetic macular edema causing visual impairment, combination intravitreal therapy with aflibercept plus dexamethasone sodium phosphate demonstrated significantly improved short-term structural outcomes (greater reduction in central retinal thickness) and functional outcomes (better visual acuity gains) compared to intravitreal aflibercept monotherapy, though it was associated with increased intraocular pressure requiring monitoring and potential treatment.
| PICO | Description |
|---|---|
| Population | Adults with diabetic macular edema causing visual impairment. |
| Intervention | Combination intravitreal aflibercept plus dexamethasone sodium phosphate. |
| Comparison | Intravitreal aflibercept monotherapy. |
| Outcome | Greater retinal thickness reduction and visual acuity gains. Increased IOP requiring monitoring. |
Clinical Context
DME is the leading cause of vision loss in working-age adults with diabetes. Anti-VEGF agents are first-line therapy, but corticosteroids address complementary inflammatory pathways.
Clinical Pearls
1. Mechanistic Synergy: Anti-VEGF and corticosteroids target different but overlapping pathways in DME pathophysiology.
2. Dexamethasone Phosphate vs Implant: Soluble form has shorter duration but may cause fewer IOP issues than the implant.
3. IOP Monitoring Essential: Steroid-induced ocular hypertension occurred more frequently with combination therapy.
4. Short-Term Phase 2 Data: Longer-term phase 3 trials needed to confirm durability and characterize cumulative steroid risks.
Practical Application
Consider combination therapy for patients with suboptimal anti-VEGF monotherapy response. Avoid in patients with glaucoma or known steroid response.
Study Limitations
Phase 2 trial with limited sample size and follow-up duration. Short-term outcomes may not predict long-term visual function.
Bottom Line
Combination aflibercept plus dexamethasone improves DME outcomes but carries increased IOP risk requiring monitoring.
Source: Neri VC, et al. “Intravitreal Aflibercept Alone Versus Combination with Dexamethasone Phosphate for Diabetic Macular Edema: A Randomized Phase-2 Clinical Trial.” Read article
