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Ozurdex for Retinal Vein Occlusion Study (ORVO Study) (ORVO)

Primary Purpose

Retinal Vein Occlusion

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
dexamethasone implant
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinal Vein Occlusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wilmer Eye Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

CRVO

BRVO

Arm Description

Central Retinal Vein Occlusion

Branch Retinal Vein Occlusion

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 8, 2013
Last Updated
April 2, 2015
Sponsor
Johns Hopkins University
Collaborators
Allergan
search

1. Study Identification

Unique Protocol Identification Number
NCT01790685
Brief Title
Ozurdex for Retinal Vein Occlusion Study (ORVO Study)
Acronym
ORVO
Official Title
Ozurdex for Retinal Vein Occlusion Study (ORVO Study)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins University
Collaborators
Allergan

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Vein Occlusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CRVO
Arm Type
Other
Arm Description
Central Retinal Vein Occlusion
Arm Title
BRVO
Arm Type
Other
Arm Description
Branch Retinal Vein Occlusion
Intervention Type
Drug
Intervention Name(s)
dexamethasone implant
Other Intervention Name(s)
Ozurdex
Primary Outcome Measure Information:
Title
Number of Participants Who Had a >30% Decrease in the Aqueous Levels of Various Vasoactive Proteins 4 Weeks After an Injection of Ozurdex
Description
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.
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Wilmer Eye Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

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Ozurdex for Retinal Vein Occlusion Study (ORVO Study)

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