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Ranibizumab Arm for Macular Edema (ORION Trial)

Phase 4
Waitlist Available
Led By VICTOR H. GONZALEZ, MD
Research Sponsored by Valley Retina Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights

ORION Trial 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.

Eligible Conditions
  • Macular Edema
  • Central Retinal Vein Occlusion

ORION Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Best Corrected Visual Acuity

ORION Trial Design

3Treatment groups
Experimental Treatment
Group I: Ranibizumab ArmExperimental Treatment1 Intervention
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.
Group II: Ozurdex ArmExperimental Treatment1 Intervention
Ozurdex intravitreal injection (combination with monthly sham injection) administered at a 16 week interval beginning on Day 1 and ending at Week 16.
Group III: Combination Ozurdex with Ranibizumab PRNExperimental Treatment1 Intervention
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ranibizumab
FDA approved
Dexamethasone
FDA approved

Find a Location

Who is running the clinical trial?

Valley Retina InstituteLead Sponsor
4 Previous Clinical Trials
154 Total Patients Enrolled
1 Trials studying Macular Edema
72 Patients Enrolled for Macular Edema
VICTOR H. GONZALEZ, MDPrincipal InvestigatorVALLEY RETINA INSTITUTE, PA

Frequently Asked Questions

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~4 spots leftby Apr 2025