Ozurdex for Retinal Vein Occlusion Study (ORVO Study)

NCT01790685 | Completed Phase 2 Results

• 1 other identifier: NA_00079951
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Retinal Vein Occlusion

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Had a >30% Decrease in the Aqueous Levels of Various Vasoactive Proteins 4 Weeks After an Injection of Ozurdex

  Vasoactive protein arrays and Enzyme linked immunosorbent assays were done for patients at baseline and week 4 visit to measure the levels of various pro-permeability factors including VEGF, SDF-1 and Angiopoietin-2.

  4 months

Study Arms (2)

CRVO

OTHER

Central Retinal Vein Occlusion

Drug: dexamethasone implant

BRVO

OTHER

Branch Retinal Vein Occlusion

Drug: dexamethasone implant

Interventions

dexamethasone implant DRUG

Also known as: Ozurdex

BRVO; CRVO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Allergan: collaborator

Study Sites (1)

Wilmer Eye Institute

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Retinal Vein Occlusion

Interventions

Dexamethasone; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Results Point of Contact

• Title: Dr. Peter A. Campochiaro
• Organization: Johns Hopkins

pcampo@jhmi.edu

410-955-5106

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 8, 2013
• First Posted: February 13, 2013
• Study Start: February 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 22, 2015
• Results First Posted: April 3, 2015

Record last verified: 2015-04

Locations

US (1)