drugset / Trial / NCT04089605

Ranibizumab vs Dexamethasone Implant in Vitrectomized Eyes With Diabetic Macular Edema

NCT04089605

Phase 4 Completed 48 enrolled Far Eastern Memorial Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

Vitrectomy is required for removal of vitreous hemorrhage or retinal traction tissue in some patients with proliferative diabetic retinopathy. Post-vitrectomy macular edema may occur in these diabetic patients. Intravitreal injections of anti-VEGF agents or corticosteroid are required for treating diabetic macular edema (DME) in vitrectomized eyes. Intraocular levels of various cytokines may alter in the diabetic eyes following vitrectomy. Pharmacokinetics may be different between various intraocular agents in vitrectomized eyes. Herein our study will prospectively randomize to compare the clinical behavior between intravitreal ranibizumab (IVR) and intravitreal dexamethasone implant (IDI) in vitrectomized patients with DME. To our knowledge, it is the first study involving such subject.

Timeline

Start
2017-06-01
Primary completion
2018-11-01
Completion
2019-04-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule 0.7 mg Intravitreal
Comparator Ranibizumab Monoclonal antibody 0.5 mg Intravitreal