Macular EdemaPhase 4ORIONNCT01827722
Ozurdex Versus Ranibizumab Versus Combination for Central Retinal Vein Occlusion
A Phase 4 study testing Ozurdex, Ranibizumab and Combination Ozurdex with Ranibizumab PRN in people with Macular Edema and Central Retinal Vein Occlusion, run by Valley Retina Institute at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Macular Edema, Central Retinal Vein Occlusion
- What is being tested?
- Ozurdex, Ranibizumab and Combination Ozurdex with Ranibizumab PRN
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 5 sitesUnited States
- Study dates
- May 2013to Dec 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Retina Vitreous Associates Medical Group
Beverly Hills, California, 90211
Daniel Bandary, 310-289-2478 ext. 1243, Dbandary@laretina.com
Janet Kurokouchi, 310-289-2478 ext. 1243
- Recruiting
Valley Retina Institute, PA
Harlingen, Texas, 78552
Anegelina Garza, BS, 956-423-2100 ext. 268, a_garza@vritx.com
Lissete Villanueva, MA, 956-423-2100 ext. 268, lvillarreal@vritx.com
- Recruiting
Retina Associates
Lakeland, Florida, 33805
Lexie Manning, 913-831-7400, lmanning@kcretina.com
David Boyer, MD
- Recruiting
Valley Retina Institute, PA
McAllen, Texas, 78503
Yesenia Salinas, MA, 956-631-8875 ext. 118, ysalinas@vritx.com
Amber Ibarra, BS, 956-631-8875 ext. 118, aibarra@vritx.com
- Recruiting
Center for Retina and Macular Disease
Winter Haven, Florida, 33880
Dawn Sutherland, 863-297-5400, dasu@crmd.net
Vera Dilts, 863-297-5400 ext. 2085, vedi@crmd.net
About this study
Official title: Ozurdex Versus Ranibizumab Versus Combination for Central Retinal Vein
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.
Read more
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.
Read the 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.
- Conditions
- Macular Edema, Central Retinal Vein Occlusion
- Being tested
- Ozurdex, Ranibizumab, Combination Ozurdex with Ranibizumab PRN
- Keywords
- Macular edema, Central retinal vein occlusion, CRVO, Retinal vein occlusion, RVO, Ozurdex, Dexamethasone intravitreal implant, Lucentis, Ranibizumab
- Medical subject headings
- Macular Edema, Retinal Vein Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OzurdexDrug
Also called Dexamethasone
Intravitreal injection of Ozurdex
RanibizumabDrug
Also called Lucentis
Intravitreal Injection of Ranibizumab
Combination Ozurdex with Ranibizumab PRNDrug
Also called Dexamethasone and Lucentis
Intravitreal Injection of combination medication Ozurdex and Ranibizumab
| Study group | Role | What they receive |
|---|---|---|
| Ozurdex Arm | Experimental | Ozurdex intravitreal injection (combination with monthly sham injection) administered at a 16 week interval beginning on Day 1 and ending at Week 16. Receives: Drug: Ozurdex |
| Ranibizumab Arm | Experimental | 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. Receives: Drug: Ranibizumab |
| Combination Ozurdex with Ranibizumab PRN | Experimental | 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). Receives: Drug: Combination Ozurdex with Ranibizumab PRN |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2013 (estimated)
- Study startMay 2013
- Primary completionMay 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Valley Retina Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Victor H. Gonzalez, MD, Valley Retina Institute
- Investigators
- VICTOR H. GONZALEZ, MD, Principal investigator, VALLEY RETINA INSTITUTE, PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01827722
- Sponsor's protocol ID
- ORION
- Acronym
- ORION
- Status last verified
- Dec 2015
- First submitted
- 4 Apr 2013
- Last updated
- 14 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ozurdex Versus Ranibizumab Versus Combination for Central Retinal Vein
- ClinicalTrials.gov ID
- NCT01827722
- Acronym / sponsor ID
- ORION / ORION
- Conditions
- Macular Edema, Central Retinal Vein Occlusion
- Keywords
- Macular edema, Central retinal vein occlusion, CRVO, Retinal vein occlusion, RVO, Ozurdex, Dexamethasone intravitreal implant, Lucentis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Valley Retina InstituteUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- May 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 10 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ozurdex Arm | Experimental | Drug: OzurdexOzurdex intravitreal injection (combination with monthly sham injection) administered at a 16 week interval beginning on Day 1 and ending at Week 16. |
| Ranibizumab Arm | Experimental | Drug: RanibizumabRanibizumab injection (combination with sham injections beginning on Day 1 and Week 16) administered at monthly intervals beginning Day 1 and ending at Week 20. |
| Combination Ozurdex with Ranibizumab PRN | Experimental | Drug: Combination Ozurdex with Ranibizumab PRNOzurdex 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OzurdexAlso: DexamethasoneIntravitreal injection of Ozurdex | Drug | Ozurdex Arm |
| RanibizumabAlso: LucentisIntravitreal Injection of Ranibizumab | Drug | Ranibizumab Arm |
| Combination Ozurdex with Ranibizumab PRNAlso: Dexamethasone and LucentisIntravitreal Injection of combination medication Ozurdex and Ranibizumab | Drug | Combination Ozurdex with Ranibizumab PRN |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
VICTOR H. GONZALEZ, MD principal investigator
VALLEY RETINA INSTITUTE, PA
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ozurdex, Ranibizumab and Combination Ozurdex with Ranibizumab PRN in people with Macular Edema and Central Retinal Vein Occlusion, run by Valley Retina Institute at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact VICTOR H GONZALEZ, MD (956-631-8875 ext. 118, RESEARCH@VRITX.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best Corrected Visual Acuity (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2015.