CompletedNCT01295112Updated Sep 25, 2025Results posted

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

A Phase 2/3 interventional study of Active bevacizumab and Sham dexamethasone and Active bevacizumab and Active dexamethasone in Non-Ischemic Central Retinal Vein Occlusion, sponsored by Texas Retina Associates. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-25.

Sponsored by Texas Retina Associates · Phase 2/3, Interventional, and Treatment

Phase: Phase 2/3
Study type: Interventional
Enrollment: 68
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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 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 studied

Non-Ischemic Central Retinal Vein Occlusion

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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.

Study design

Phase: Phase 2 / Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Participant)
Enrollment: 68 participants (actual)

Study arms

Sham comparator
Group 1
Active bevacizumab (Avastin®) and Sham Ozurdex®
Drug: Active bevacizumab and Sham dexamethasone
Active comparator
Group 2
Active bevacizumab (Avastin®) and Active Ozurdex®
Drug: Active bevacizumab and Active dexamethasone

Interventions

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

What researchers measure

Primary outcomes

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

Secondary outcomes

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
Time frame: 24 weeks

Results

Posted Oct 18, 2017

Limitations and caveats

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.

Participant flow

A total of 68 participants ≥18 years of age with a diagnosis of central retinal vein occlusion (CRVO) as determined by fundus photography and fluorescein angiography were enrolled in the study at 5 clinical centers.

Participant flow — Overall Study
Milestone	Group 1	Group 2
Started	35	33
Completed	35	33
Not completed	0	0

Outcome measures

PrimaryThe Primary Efficacy Endpoint is the Total Number of PRN Bevacizumab Intravitreal Injections Through 24 Weeks

Time frame:: 24 weeks
Reported as:: Count of participants · Participants

The Primary Efficacy Endpoint is the Total Number of PRN Bevacizumab Intravitreal Injections Through 24 Weeks
Participants	Group 1	Group 2
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

Statistical analysis

Group 1 vs Group 2 · Cochran-Mantel-Haenszel · p = 0.00002

SecondaryThe 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

Time frame:: 24 weeks
Reported as:: Mean · letters

The Secondary Efficacy Endpoint is the Visual Acuity Score Based on Best Corrected Visual Acuity (BCVA) at Week 24
letters	Group 1	Group 2
The Secondary Efficacy Endpoint is the Visual Acuity Score Based on Best Corrected Visual Acuity (BCVA) at Week 24	16.20 ± 15.49	13.55 ± 19.41

Statistical analysis

Group 1 vs Group 2 · t-test, 1 sided · p = 0.53 (The p-value is assume superiority. The 95% upper confidence (upper end of the 90% Confidence interval) interval for the non-inferiority analysis is provided below.) · Mean difference (final values): 2.51 · 90% CI -4.43 to 9.74

Adverse events

Collected over 24 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Group 1	0/35 (0%)	0/35 (0%)	0/35 (0%)
Group 2	0/33 (0%)	0/33 (0%)	0/33 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Group 1	Group 2	Total
Mean	66.4 ± 15.0	70.7 ± 12.6	68.5 ± 14.0

Sex: Female, Male
Sex: Female, Male(Participants)	Group 1	Group 2	Total
Female	13	16	29
Male	22	17	39

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Group 1	Group 2	Total
Asian	1	1	2
Black	2	1	3
Caucasian	25	24	49
Hispanic	5	5	10
Not Reported	2	2	4

Previous Injections
Previous Injections(Participants)	Group 1	Group 2	Total
Bevacizumab	5	8	13
No Injection	22	21	43
Ranibizumab	4	3	7
Bevacizumab and Ranibizumab	1	1	2
Bevacizumab and Aflibercept	3	0	3

Study Eye
Study Eye(Participants)	Group 1	Group 2	Total
Right Eye	18	15	33
Left Eye	17	18	35

Baseline best corrected visual acuity (BCVA) in Study Eye
Baseline best corrected visual acuity (BCVA) in Study Eye(letters)	Group 1	Group 2	Total
Mean	49.6 ± 18.2	55.7 ± 17.2	52.5 ± 17.8

Baselinen best corrected visual acuity (BCVA) in Fellow Eye
Baselinen best corrected visual acuity (BCVA) in Fellow Eye(letters)	Group 1	Group 2	Total
Mean	82.0 ± 12.6	82.2 ± 9.6	82.1 ± 11.2

Baseline Central Foveal Thickness in Study Eye
Baseline Central Foveal Thickness in Study Eye(microns)	Group 1	Group 2	Total
Mean	264.5 ± 68.9	262.1 ± 70.0	263.3 ± 68.8

1 further baseline measures are reported on the registry.

Study locations

1 site

Texas Retina Associates
Dallas, Texas 75231, United States

Registry details

Key details

Study ID: NCT01295112
Lead sponsor: Texas Retina Associates
Responsible party: Sponsor
First posted: Feb 14, 2011
Start date: May 2011
Primary completion: Oct 2015
Completion: Oct 2015
Results posted: Oct 18, 2017
Last update: Sep 25, 2025

Study contacts

Karl Csaky, MD

principal investigator · Texas Retina Associates

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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