Non-Ischemic Central Retinal Vein OcclusionPhase 2/3NCT01295112

Effect of Ozurdex® 0.7 mg on Improvement of Efficacy of Bevacizumab for Central Retinal Vein Occlusion

A Phase 2/3 study testing Active bevacizumab and Active dexamethasone in people with Non-Ischemic Central Retinal Vein Occlusion, run by Texas Retina Associates at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a study designed to determine if the addition of Ozurdex® to bevacizumab (Avastin®) eye injections reduces the need for repeat bevacizumab eye injections in patients with nonischemic central retina vein occlusion. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Non-Ischemic Central Retinal Vein Occlusion
What is being tested?: Active bevacizumab and Active dexamethasone
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 68 participants
Where: 1 siteUnited States
Study dates: May 2011to Oct 2015
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

male or female subjects (aged 18 or older);
provide written informed consent and sign/date a health information release;
women of childbearing potential must be willing to practice effective contraception for the duration of the study.

Who cannot join

any systemic disease or clinical evidence of any condition which would make the subject, in the opinion of the investigator, unsuitable for the study or could potentially confound the study results;
use of systemic steroids within 1 month prior to Baseline Visit (Visit 1) or anticipated use at any time during the study (inhaled and intranasal steroids are allowed);
sitting systolic blood pressure equal to or greater than 160 mmHg or diastolic blood pressure equal to or greater than 100 mmHg at the Baseline Visit (Visit 1);
use of warfarin, heparin, enoxaparin or similar anticoagulants within 2 weeks prior to Baseline Visit (Visit 1) or anticipated use at any time during the study;
known allergy or hypersensitivity to the study medications or their components;
previous enrollment in an Ozurdex® clinical trial or previous use of an Ozurdex® implant.

Trial locations and contacts

1 site in 1 country.

United States1 site

Texas Retina Associates
Dallas, Texas, 75231

Other trials in United States

About this study

Official title: Effect of Ozurdex® 0.7 mg on Improvement of Efficacy of Bevacizumab Therapy for Non-Ischemic Central Retinal Vein Occlusion

Read the detailed description

This is a multicenter clinical study designed to determine if the addition of Ozurdex® injection to bevacizumab (Avastin®) eye injections reduces the need for repeat bevacizumab eye injections in patients with nonischemic central retina vein occlusion.

Conditions: Non-Ischemic Central Retinal Vein Occlusion
Being tested: Active bevacizumab and Sham dexamethasone, Active bevacizumab and Active dexamethasone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Active bevacizumab and Sham dexamethasoneDrug
Also called Avastin® (bevacizumab), Ozurdex® (dexamethasone intravitreal implant)
Bevacizumab: 25 mg/mL, PRN dosing Sham dexamethasone intravitreal implant: blunt needling of the sclera with no penetration of the globe
Active bevacizumab and Active dexamethasoneDrug
Also called Avastin® (bevacizumab), Ozurdex® (dexamethasone intravitreal implant)
Bevacizumab: 25 mg/mL, PRN dosing Dexamethasone intravitreal implant: 0.7 mg, single dose

Study groups in NCT01295112
Study group	Role	What they receive
Group 1	Sham comparator	Active bevacizumab (Avastin®) and Sham Ozurdex® Receives: Drug: Active bevacizumab and Sham dexamethasone
Group 2	Active comparator	Active bevacizumab (Avastin®) and Active Ozurdex® Receives: Drug: Active bevacizumab and Active dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

The Primary Efficacy Endpoint is the Total Number of PRN Bevacizumab Intravitreal Injections Through 24 Weeks
Measured: 24 weeks

Secondary outcomes (1)

The Secondary Efficacy Endpoint is the Visual Acuity Score Based on Best Corrected Visual Acuity (BCVA) at Week 24
The secondary efficacy endpoint is the visual acuity score based on best corrected visual acuity (BCVA) at Week 24 Change in BCVA at Week 24 from baseline
Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2011Oct 2015

First posted14 Feb 2011 (estimated)
Study startMay 2011
Primary completionOct 2015
Study completionOct 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Non-Ischemic Central Retinal Vein OcclusionStudies 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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 68 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01295112
Sponsor's protocol ID: TRA-OZAB-11-001
Status last verified: Sep 2017
First submitted: 10 Feb 2011
Last updated: 25 Sep 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Ozurdex® 0.7 mg on Improvement of Efficacy of Bevacizumab Therapy for Non-Ischemic Central Retinal Vein Occlusion
ClinicalTrials.gov ID: NCT01295112
Acronym / sponsor ID: TRA-OZAB-11-001
Conditions: Non-Ischemic Central Retinal Vein Occlusion
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 68 participants (actual)
Lead sponsor: Texas Retina AssociatesUniversity, hospital or other
Study start: May 2011
Primary completion: Oct 2015 (actual)
Study completion: Oct 2015 (actual)
First posted: 14 Feb 2011 (estimated)
Results: Posted 18 Oct 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Group 1	Sham comparator	Drug: Active bevacizumab and Sham dexamethasoneActive bevacizumab (Avastin®) and Sham Ozurdex®
Group 2	Active comparator	Drug: Active bevacizumab and Active dexamethasoneActive bevacizumab (Avastin®) and Active Ozurdex®

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

male or female subjects (aged 18 or older);
provide written informed consent and sign/date a health information release;
women of childbearing potential must be willing to practice effective contraception for the duration of the study.

Key exclusion criteria (6 listed)

any systemic disease or clinical evidence of any condition which would make the subject, in the opinion of the investigator, unsuitable for the study or could potentially confound the study results;
use of systemic steroids within 1 month prior to Baseline Visit (Visit 1) or anticipated use at any time during the study (inhaled and intranasal steroids are allowed);
sitting systolic blood pressure equal to or greater than 160 mmHg or diastolic blood pressure equal to or greater than 100 mmHg at the Baseline Visit (Visit 1);
use of warfarin, heparin, enoxaparin or similar anticoagulants within 2 weeks prior to Baseline Visit (Visit 1) or anticipated use at any time during the study;
known allergy or hypersensitivity to the study medications or their components;

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
Active bevacizumab and Sham dexamethasoneAlso: Avastin® (bevacizumab), Ozurdex® (dexamethasone intravitreal implant)Bevacizumab: 25 mg/mL, PRN dosing Sham dexamethasone intravitreal implant: blunt needling of the sclera with no penetration of the globe	Drug	Group 1
Active bevacizumab and Active dexamethasoneAlso: Avastin® (bevacizumab), Ozurdex® (dexamethasone intravitreal implant)Bevacizumab: 25 mg/mL, PRN dosing Dexamethasone intravitreal implant: 0.7 mg, single dose	Drug	Group 2

Primary outcome

The Primary Efficacy Endpoint is the Total Number of PRN Bevacizumab Intravitreal Injections Through 24 Weeks
Time frame: 24 weeks

1 secondary outcome

The Secondary Efficacy Endpoint is the Visual Acuity Score Based on Best Corrected Visual Acuity (BCVA) at Week 24
Time frame: 24 weeks

Results and safety

Results posted to the registry on 18 Oct 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1	35	35
Group 2	33	33

Primary outcome: The Primary Efficacy Endpoint is the Total Number of PRN Bevacizumab Intravitreal Injections Through 24 Weeks

Time frame: 24 weeks. Count of participants. Unit: Participants

Measure	Group 1 n = 35	Group 2 n = 33
0 PRN Injections	5	19
1 PRN Injection	13	11
2 PRN Injections	10	3
3 PRN Injections	6	0
4 PRN Injections	1	0

Group 1 vs Group 2: p = 0.00002, Cochran-Mantel-Haenszel

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 24 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1	0 of 35 (0%)	0 of 35 (0%)	0 of 35
Group 2	0 of 33 (0%)	0 of 33 (0%)	0 of 33

Limitations and caveats (from the sponsor): Limitations of this study included the relatively small size of 68 eyes, however statistical analyses were robust. The sample size was small due to the disease of study being a rare disease of study so the sample size is limited.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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.

Karl Csaky, MD principal investigator

Texas Retina Associates

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Active bevacizumab and Active dexamethasone in people with Non-Ischemic Central Retinal Vein Occlusion, run by Texas Retina Associates at 1 site 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Primary Efficacy Endpoint is the Total Number of PRN Bevacizumab Intravitreal Injections Through 24 Weeks (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01295112.

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 25 Sep 2025.