Ozurdex Versus Ranibizumab Versus Combination for Central Retinal Vein Occlusion
Status:
Unknown status
Trial end date:
2016-12-01
Target enrollment:
Participant gender:
Summary
CRVO occurs when the vessels in the back of the eye become blocked. This creates a dangerous
condition because the vessels are weak and prone to leakage. This results in the development
of macular edema.
Previous studies have shown that inflammatory mediators and growth factors, such as vascular
endothelial growth factor (VEGF), are elevated in patients with macular edema associated with
CRVO.
Ozurdex® is approved by the Food and Drug Administration (FDA) and is available by
prescription for macular edema following CRVO and branch retinal vein occlusion (BRVO). It is
also indicated for the treatment of non-infectious uveitis affecting the posterior segment of
the eye. The approved dosage is 0.7 mg.
Ranibizumab (Lucentis®) is approved by the Food and Drug Administration (FDA) and is
available by prescription for other eye disorders, such as wet age-related macular
degeneration (AMD), macular edema following CRVO or BRVO, and diabetic macular edema (DME).
The approved dosage for wet AMD and macular edema following CRVO/BROV is 0.5 mg given
monthly. The approved dosage for DME is 0.3 mg given monthly.
Dr. Gonzalez is conducting an investigational study on the safety and effectiveness of
treating CRVO-associated Macular Edema with a combination of 0.7 mg of Ozurdex® and 0.5 mg
Lucentis®, given as separate injections into the eye.