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
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.
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.
289 studies on the registry are indexed under Retinal Vein Occlusion; 32 are open to participants now.
This study's enrollment of 68 is above the median of 51 across 208 interventional studies indexed under Retinal Vein Occlusion.
Browse Retinal Vein Occlusion studies →Texas Retina Associates is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Active bevacizumab (Avastin®) and Sham Ozurdex®
Drug: Active bevacizumab and Sham dexamethasone
Active bevacizumab (Avastin®) and Active Ozurdex®
Drug: Active bevacizumab and Active 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)
Drug page: Bevacizumab
Bevacizumab: 25 mg/mL, PRN dosing Dexamethasone intravitreal implant: 0.7 mg, single dose
Also known as: Avastin® (bevacizumab), Ozurdex® (dexamethasone intravitreal implant)
The Primary Efficacy Endpoint is the Total Number of PRN Bevacizumab Intravitreal Injections Through 24 Weeks
Time frame: 24 weeks
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
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.
| Milestone | Group 1 | Group 2 |
|---|---|---|
| Started | 35 | 33 |
| Completed | 35 | 33 |
| Not completed | 0 | 0 |
| 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 |
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
| 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 |
Collected over 24 weeks. Non-serious events are listed at a 0% frequency threshold.
| 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%) |
| Age, Continuous(years) | Group 1 | Group 2 | Total |
|---|---|---|---|
| Mean | 66.4 ± 15.0 | 70.7 ± 12.6 | 68.5 ± 14.0 |
| Sex: Female, Male(Participants) | Group 1 | Group 2 | Total |
|---|---|---|---|
| Female | 13 | 16 | 29 |
| Male | 22 | 17 | 39 |
| 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(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(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(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(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(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.
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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Studies of the drug tested here: Bevacizumab
Texas Retina Associates