search
Back to results

Ozurdex Versus Ranibizumab Versus Combination for Central Retinal Vein Occlusion (ORION)

Primary Purpose

Macular Edema, Central Retinal Vein Occlusion

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ozurdex
Ranibizumab
Combination Ozurdex with Ranibizumab PRN
Sponsored by
Valley Retina Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Edema focused on measuring Macular edema, Central retinal vein occlusion, CRVO, Retinal vein occlusion, RVO, Ozurdex, Dexamethasone intravitreal implant, Lucentis, Ranibizumab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Adults greater than or equal to 18 years of age with foveal center involved macular edema secondary to CRVO diagnosed within 12 months before the screening visit (CRVO is defined as an eye with retinal hemorrhage or other biomicroscopic evidence of RVO [eg telangiectatic capillary bed] and a dilated [or previously dilated] venous system in at least 3 quadrants of the retina drained by the affected vein.
  • Best corrected visual acuity (ETDRS) letter score of 73 to 24 inclusive (20/40 to 20/320) in the study eye at Screening and at Day 1
  • Mean central subfield thickness greater than or equal to 310 µm from 2 OCT measurements (Spectralis HRA + OCT) at Screening and Day 1
  • Willing and able to comply with clinic visits and study-related procedures
  • Ability to provide signed informed consent form

Exclusion Criteria:

  • History of vitreoretinal surgery in the study eye or anticipated within 12 months of Day 1
  • Current bilateral manifestation of CRVO
  • Decrease in VA due to causes other than CRVO in the study eye
  • Prior episode of RVO in study eye
  • Afferent pupillary defect, obvious and unequivocal
  • Greater than 10 letter improvement in BCVA between Screening and Day 1
  • History or presence of exudative or dry macular degeneration
  • Panretinal scatter photocoagulation or sector laser photocoagulation within 3 months prior to Day 1 or anticipated within 4 months after Day 1
  • Anticipated laser photocoagulation for macular edema within 4 months after Day 1
  • History of or evidence on examination of any diabetic retinopathy in the study eye
  • CVA or MI within 3 months prior to Day 1
  • Prior anti-VEGF treatment in study or fellow eye within 3 months before day 1 or systemic anti-VEGF or pro-VEGF treatment within 6 months prior to Day 1
  • Ocular or periocular infections including active or suspected viral diseases of the cornea and conjunctiva, active epithelial herpes simples keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases
  • Glaucoma or current ocular hypertension requiring more than 1 medication to control IOP in the study eye or a history of steroid induced IOP increase in either eye
  • Prior Ozurdex treatment in study eye within 4 months prior to Day 1
  • Aphakic eyes with rupture of posterior lens capsule
  • Anterior chamber IOL and rupture of posterior lens capsule
  • Hypersensitivity to any components of Ozurdex or Ranibizumab in either eye
  • History of other disease, metabolic dysfunction, physical exam finding, including renal failure on dialysis which renders the patient at high risk from treatment complications based on the judgment of the Investigator's at his/her discretion.
  • Sexually active men or women of childbearing potential who are unwilling to practice adequate contraception during the study (adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly).

Sites / Locations

  • Retina Vitreous Associates Medical GroupRecruiting
  • Retina AssociatesRecruiting
  • Center for Retina and Macular DiseaseRecruiting
  • Valley Retina Institute, PARecruiting
  • Valley Retina Institute, PARecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Ozurdex Arm

Ranibizumab Arm

Combination Ozurdex with Ranibizumab PRN

Arm Description

Ozurdex intravitreal injection (combination with monthly sham injection) administered at a 16 week interval beginning on Day 1 and ending at Week 16.

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.

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).

Outcomes

Primary Outcome Measures

Best Corrected Visual Acuity
At week 24 the mean change in best corrected visual acuity from baseline will be compared between the three groups: Ozurdex alone, Ranibizumab alone, and Ozurdex/Ranibizumab combination.

Secondary Outcome Measures

Full Information

First Posted
April 4, 2013
Last Updated
December 10, 2015
Sponsor
Valley Retina Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT01827722
Brief Title
Ozurdex Versus Ranibizumab Versus Combination for Central Retinal Vein Occlusion
Acronym
ORION
Official Title
Ozurdex Versus Ranibizumab Versus Combination for Central Retinal Vein
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
May 2013 (undefined)
Primary Completion Date
May 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Valley Retina Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
This is a 52 week, single masked, 1:1:1, randomized, phase IV, multicenter injection controlled clinical study with a 24 week treatment phase followed by a 24 week follow up phase. Subjects will be randomly assigned to Ozurdex every 16 weeks, Ranibizumab monthly, or combination Ozurdex every 16 weeks with Ranibizumab. Patients assigned to IV Ozurdex arm will receive a total of 2 intravitreal Ozurdex injections (in combination with monthly Ranibizumab sham) administered at 16 week intervals beginning on Day 1 and ending at Week 16. Patients assigned to IV Ranibizumab arm will receive injections administered at monthly intervals (in combination with Ozurdex sham beginning on Day 1 and Week 16). Patients assigned to IV Ozurdex with IV Ranibizumab will receive a total of 2 intravitreal Ozurdex injections administered at Week 16 intervals beginning on Day 1 and ending at Week 16 with an initial IV Ranibizumab injection administered on Day 1, then treated with Ranibizumab according to reinjection parameters assessed monthly through Week 20 (in combination with Ranibizumab sham if Ranibizumab reinjection parameters are not met). Treatment at end of study treatment phase Week 24 will be standard of care for all arms at the Investigator's discretion.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Edema, Central Retinal Vein Occlusion
Keywords
Macular edema, Central retinal vein occlusion, CRVO, Retinal vein occlusion, RVO, Ozurdex, Dexamethasone intravitreal implant, Lucentis, Ranibizumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ozurdex Arm
Arm Type
Experimental
Arm Description
Ozurdex intravitreal injection (combination with monthly sham injection) administered at a 16 week interval beginning on Day 1 and ending at Week 16.
Arm Title
Ranibizumab Arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Combination Ozurdex with Ranibizumab PRN
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Ozurdex
Other Intervention Name(s)
Dexamethasone
Intervention Description
Intravitreal injection of Ozurdex
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
Intravitreal Injection of Ranibizumab
Intervention Type
Drug
Intervention Name(s)
Combination Ozurdex with Ranibizumab PRN
Other Intervention Name(s)
Dexamethasone and Lucentis
Intervention Description
Intravitreal Injection of combination medication Ozurdex and Ranibizumab
Primary Outcome Measure Information:
Title
Best Corrected Visual Acuity
Description
At week 24 the mean change in best corrected visual acuity from baseline will be compared between the three groups: Ozurdex alone, Ranibizumab alone, and Ozurdex/Ranibizumab combination.
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adults greater than or equal to 18 years of age with foveal center involved macular edema secondary to CRVO diagnosed within 12 months before the screening visit (CRVO is defined as an eye with retinal hemorrhage or other biomicroscopic evidence of RVO [eg telangiectatic capillary bed] and a dilated [or previously dilated] venous system in at least 3 quadrants of the retina drained by the affected vein. Best corrected visual acuity (ETDRS) letter score of 73 to 24 inclusive (20/40 to 20/320) in the study eye at Screening and at Day 1 Mean central subfield thickness greater than or equal to 310 µm from 2 OCT measurements (Spectralis HRA + OCT) at Screening and Day 1 Willing and able to comply with clinic visits and study-related procedures Ability to provide signed informed consent form Exclusion Criteria: History of vitreoretinal surgery in the study eye or anticipated within 12 months of Day 1 Current bilateral manifestation of CRVO Decrease in VA due to causes other than CRVO in the study eye Prior episode of RVO in study eye Afferent pupillary defect, obvious and unequivocal Greater than 10 letter improvement in BCVA between Screening and Day 1 History or presence of exudative or dry macular degeneration Panretinal scatter photocoagulation or sector laser photocoagulation within 3 months prior to Day 1 or anticipated within 4 months after Day 1 Anticipated laser photocoagulation for macular edema within 4 months after Day 1 History of or evidence on examination of any diabetic retinopathy in the study eye CVA or MI within 3 months prior to Day 1 Prior anti-VEGF treatment in study or fellow eye within 3 months before day 1 or systemic anti-VEGF or pro-VEGF treatment within 6 months prior to Day 1 Ocular or periocular infections including active or suspected viral diseases of the cornea and conjunctiva, active epithelial herpes simples keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases Glaucoma or current ocular hypertension requiring more than 1 medication to control IOP in the study eye or a history of steroid induced IOP increase in either eye Prior Ozurdex treatment in study eye within 4 months prior to Day 1 Aphakic eyes with rupture of posterior lens capsule Anterior chamber IOL and rupture of posterior lens capsule Hypersensitivity to any components of Ozurdex or Ranibizumab in either eye History of other disease, metabolic dysfunction, physical exam finding, including renal failure on dialysis which renders the patient at high risk from treatment complications based on the judgment of the Investigator's at his/her discretion. Sexually active men or women of childbearing potential who are unwilling to practice adequate contraception during the study (adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
VICTOR H GONZALEZ, MD
Phone
956-631-8875
Ext
118
Email
RESEARCH@VRITX.COM
First Name & Middle Initial & Last Name or Official Title & Degree
YESENIA SALINAS, MA
Phone
956-631-8875
Ext
118
Email
YSALINAS@VRITX.COM
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
VICTOR H. GONZALEZ, MD
Organizational Affiliation
VALLEY RETINA INSTITUTE, PA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Retina Vitreous Associates Medical Group
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Bandary
Phone
310-289-2478
Ext
1243
Email
Dbandary@laretina.com
First Name & Middle Initial & Last Name & Degree
Janet Kurokouchi
Phone
310-289-2478
Ext
1243
First Name & Middle Initial & Last Name & Degree
David S Boyer, MD
Facility Name
Retina Associates
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lexie Manning
Phone
913-831-7400
Email
lmanning@kcretina.com
First Name & Middle Initial & Last Name & Degree
David Boyer, MD
Facility Name
Center for Retina and Macular Disease
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dawn Sutherland
Phone
863-297-5400
Email
dasu@crmd.net
First Name & Middle Initial & Last Name & Degree
Vera Dilts
Phone
863-297-5400
Ext
2085
Email
vedi@crmd.net
First Name & Middle Initial & Last Name & Degree
Michael Tolentino, MD
Facility Name
Valley Retina Institute, PA
City
Harlingen
State/Province
Texas
ZIP/Postal Code
78552
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anegelina Garza, BS
Phone
956-423-2100
Ext
268
Email
a_garza@vritx.com
First Name & Middle Initial & Last Name & Degree
Lissete Villanueva, MA
Phone
956-423-2100
Ext
268
Email
lvillarreal@vritx.com
First Name & Middle Initial & Last Name & Degree
Victor H. Gonzalez, MD
Facility Name
Valley Retina Institute, PA
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yesenia Salinas, MA
Phone
956-631-8875
Ext
118
Email
ysalinas@vritx.com
First Name & Middle Initial & Last Name & Degree
Amber Ibarra, BS
Phone
956-631-8875
Ext
118
Email
aibarra@vritx.com
First Name & Middle Initial & Last Name & Degree
Victor H Gonzalez, MD

12. IPD Sharing Statement

Learn more about this trial

Ozurdex Versus Ranibizumab Versus Combination for Central Retinal Vein Occlusion

We'll reach out to this number within 24 hrs