Ozurdex Versus Ranibizumab Versus Combination for Central Retinal Vein Occlusion (ORION)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01827722|
Recruitment Status : Unknown
Verified December 2015 by Victor H. Gonzalez, MD, Valley Retina Institute.
Recruitment status was: Recruiting
First Posted : April 10, 2013
Last Update Posted : December 14, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Macular Edema Central Retinal Vein Occlusion||Drug: Ozurdex Drug: Ranibizumab Drug: Combination Ozurdex with Ranibizumab PRN||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Ozurdex Versus Ranibizumab Versus Combination for Central Retinal Vein|
|Study Start Date :||May 2013|
|Estimated Primary Completion Date :||May 2016|
|Estimated Study Completion Date :||December 2016|
Experimental: Ozurdex Arm
Ozurdex intravitreal injection (combination with monthly sham injection) administered at a 16 week interval beginning on Day 1 and ending at Week 16.
Intravitreal injection of Ozurdex
Other Name: Dexamethasone
Experimental: Ranibizumab Arm
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.
Intravitreal Injection of Ranibizumab
Other Name: Lucentis
Experimental: Combination Ozurdex with Ranibizumab PRN
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).
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).
Drug: Combination Ozurdex with Ranibizumab PRN
Intravitreal Injection of combination medication Ozurdex and Ranibizumab
Other Name: Dexamethasone and Lucentis
- Best Corrected Visual Acuity [ Time Frame: 24 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01827722
|Contact: VICTOR H GONZALEZ, MD||956-631-8875 ext 118||RESEARCH@VRITX.COM|
|Contact: YESENIA SALINAS, MA||956-631-8875 ext 118||YSALINAS@VRITX.COM|
|United States, California|
|Retina Vitreous Associates Medical Group||Recruiting|
|Beverly Hills, California, United States, 90211|
|Contact: Daniel Bandary 310-289-2478 ext 1243 Dbandary@laretina.com|
|Contact: Janet Kurokouchi 310-289-2478 ext 1243|
|Principal Investigator: David S Boyer, MD|
|United States, Florida|
|Lakeland, Florida, United States, 33805|
|Contact: Lexie Manning 913-831-7400 firstname.lastname@example.org|
|Principal Investigator: David Boyer, MD|
|Center for Retina and Macular Disease||Recruiting|
|Winter Haven, Florida, United States, 33880|
|Contact: Dawn Sutherland 863-297-5400 email@example.com|
|Contact: Vera Dilts 863-297-5400 ext 2085 firstname.lastname@example.org|
|Principal Investigator: Michael Tolentino, MD|
|United States, Texas|
|Valley Retina Institute, PA||Recruiting|
|Harlingen, Texas, United States, 78552|
|Contact: Anegelina Garza, BS 956-423-2100 ext 268 email@example.com|
|Contact: Lissete Villanueva, MA 956-423-2100 ext 268 firstname.lastname@example.org|
|Principal Investigator: Victor H. Gonzalez, MD|
|Valley Retina Institute, PA||Recruiting|
|McAllen, Texas, United States, 78503|
|Contact: Yesenia Salinas, MA 956-631-8875 ext 118 email@example.com|
|Contact: Amber Ibarra, BS 956-631-8875 ext 118 firstname.lastname@example.org|
|Principal Investigator: Victor H Gonzalez, MD|
|Principal Investigator:||VICTOR H. GONZALEZ, MD||VALLEY RETINA INSTITUTE, PA|