Ozurdex for Retinal Vein Occlusion Study (ORVO Study)

Retinal Vein Occlusion Clinical Trial

— ORVO  

Official title:

Ozurdex for Retinal Vein Occlusion Study (ORVO Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01790685
• Other study ID #: NA_00079951
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 8, 2013
• Last updated: April 2, 2015
• Start date: February 2013
• Est. completion date: December 2014

Study information

• Verified date: April 2015
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Retinal Vein Occlusion

Intervention

Drug:
• dexamethasone implant

Locations

Country	Name	City	State
United States	Wilmer Eye Institute	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No