Ozurdex Versus Ranibizumab Versus Combination for Central Retinal Vein Occlusion

Conditions

• Central Retinal Vein Occlusion
• Macular Edema

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Ozurdex — DRUG
  Intravitreal injection of Ozurdex
• Ranibizumab — DRUG
  Intravitreal Injection of Ranibizumab
• Combination Ozurdex with Ranibizumab PRN — DRUG
  Intravitreal Injection of combination medication Ozurdex and Ranibizumab

Study Details

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.

Key Dates

First listed

Apr 10, 2013

Start date

May 31, 2013

Status verified

Dec 2015

Primary completion

May 31, 2016

Completion

Dec 31, 2016

Study Design

Enrollment

45 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Ozurdex Arm
  Ozurdex intravitreal injection (combination with monthly sham injection) administered at a 16 week interval beginning on Day 1 and ending at Week 16.
• Experimental: Ranibizumab Arm
  Ranibizumab injection (combination with sham injections beginning on Day 1 and Week 16) administered at monthly intervals beginning Day 1 and ending at Week 20.
• Experimental: Combination Ozurdex with Ranibizumab PRN
  Ozurdex intravitreal injection administered at 16 week intervals beginning on Day 1 and ending at Week 16 with an initial IV Ranibizumab injection administered at Day 1, then treated with Ranibizumab according to reinjection parameters assessed monthly (in combination with sham if reinjection parameters are not met). Reinjection Parameters: 10 letter drop from best corrected visual acuity or a 100 µm increase in central retinal thickness according to optical coherence tomography (Spectralis HRA + OCT).

Primary Outcome Measure

Best Corrected Visual Acuity [ Time Frame: 24 weeks ]

Central Contacts

• VICTOR H GONZALEZ, MD
  956-631-8875
  [email protected]
• YESENIA SALINAS, MA
  956-631-8875
  [email protected]

Locations (5)

Find similar trials in Beverly Hills, CA

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