Ozurdex for Retinal Vein Occlusion Study (ORVO Study)

NCT ID: NCT01790685

Last Updated: 2015-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2014-12-31

Brief Summary

To measure the pro-permeability factors in the aqueous humor of patients with persistent/recurrent macular edema after an injection of Ozurdex.

Detailed Description

To measure various pro-permeability factors in the aqueous humor of patients with persistent/recurrent macular edema despite prior treatment with anti-VEGF agents at baseline and at 4 weeks after intraocular injection of OZURDEX.

Conditions

Retinal Vein Occlusion

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CRVO

Central Retinal Vein Occlusion

Group Type: OTHER

dexamethasone implant

Intervention Type: DRUG

BRVO

Branch Retinal Vein Occlusion

Group Type: OTHER

dexamethasone implant

Intervention Type: DRUG

Interventions

dexamethasone implant

Intervention Type: DRUG

Other Intervention Names

Ozurdex

Eligibility Criteria

Inclusion Criteria

• Signed informed consent and authorization of use and disclosure of protected health information
• Age more than or equal to 18 years
• Diagnosis of macular edema due to central or branch retinal vein occlusion
• Intraretinal or subretinal fluid in the macula determined by Spectralis OCT
• Best corrected visual acuity score in the study eye of 20/30 to 20/400 inclusive (Snellen equivalents using the ETDRS protocol at a distance of 4 meters)
• In the opinion of the investigator, decreased vision in the study eye is due to foveal thickening from vein occlusion and not from other obvious causes of decreased vision
• Persistent or recurrent edema despite prolonged treatment with an anti-VEFG agent

Exclusion Criteria

• Scatter laser photocoagulation or macular photocoagulation within 3 months of study entry in the study eye
• Intraocular surgery in the study eye within 3 months of study entry
• Use of intraocular or periocular injection of steroids in the study eye (e.g., triamcinolone) within 4 months of study entry
• Previous use of an anti-VEGF drug within 1 month of study entry
• Yttrium-Aluminum-Garnet (YAG) laser capsulotomy within 1 month of study entry
• Any condition that the investigator believes would pose a significant hazard to the subject if investigational therapy were initiated.
• Inability to comply with study or follow up procedures
• History of glaucoma or documented history of steroid-induced glaucoma.
• Patients with active or suspected ocular or periocular infection, including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases.
• Aphakic eyes with rupture of the posterior lens capsule.
• Eyes with ACIOL and rupture of the posterior lens capsule.
• Patients with hypersensitivity to dexamethasone or to any other components of the product

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Allergan

INDUSTRY

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Peter A Campochiaro, MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Wilmer Eye Institute

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

NA_00079951

Identifier Type: -

Identifier Source: org_study_id