Macular Edema Clinical Trial
Official title:
Ozurdex Versus Ranibizumab Versus Combination for Central Retinal Vein
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.
This is a 52 week, single masked, 1:1:1, randomized, phase IV, multicenter injection controlled clinical study with a 24 week treatment phase followed by a 24 week follow up phase. Subjects will be randomly assigned to Ozurdex every 16 weeks, Ranibizumab monthly, or combination Ozurdex every 16 weeks with Ranibizumab. Patients assigned to IV Ozurdex arm will receive a total of 2 intravitreal Ozurdex injections (in combination with monthly Ranibizumab sham) administered at 16 week intervals beginning on Day 1 and ending at Week 16. Patients assigned to IV Ranibizumab arm will receive injections administered at monthly intervals (in combination with Ozurdex sham beginning on Day 1 and Week 16). Patients assigned to IV Ozurdex with IV Ranibizumab will receive a total of 2 intravitreal Ozurdex injections administered at Week 16 intervals beginning on Day 1 and ending at Week 16 with an initial IV Ranibizumab injection administered on Day 1, then treated with Ranibizumab according to reinjection parameters assessed monthly through Week 20 (in combination with Ranibizumab sham if Ranibizumab reinjection parameters are not met). Treatment at end of study treatment phase Week 24 will be standard of care for all arms at the Investigator's discretion. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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