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

NCT01295112 | Completed Phase 2 Results

• 1 other identifier: TRA-OZAB-11-001
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-Ischemic Central Retinal Vein Occlusion

Outcome Measures

Primary Outcomes (1)

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

  24 weeks

Secondary Outcomes (1)

• The Secondary Efficacy Endpoint is the Visual Acuity Score Based on Best Corrected Visual Acuity (BCVA) at Week 24

  24 weeks

Study Arms (2)

Group 1

SHAM COMPARATOR

Active bevacizumab (Avastin®) and Sham Ozurdex®

Drug: Active bevacizumab and Sham dexamethasone

Group 2

ACTIVE COMPARATOR

Active bevacizumab (Avastin®) and Active Ozurdex®

Drug: Active bevacizumab and Active dexamethasone

Interventions

Active bevacizumab and Sham dexamethasone DRUG

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)

Group 1

Active bevacizumab and Active dexamethasone DRUG

Bevacizumab: 25 mg/mL, PRN dosing Dexamethasone intravitreal implant: 0.7 mg, single dose

Also known as: Avastin® (bevacizumab), Ozurdex® (dexamethasone intravitreal implant)

Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Texas Retina Associates: lead

Study Sites (1)

Texas Retina Associates

Dallas, Texas, 75231, United States

Location

MeSH Terms

Interventions

Bevacizumab; Calcium Dobesilate; Dexamethasone

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

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.

Results Point of Contact

• Title: Traci Clemons
• Organization: The Emmes Corporation

tclemons@emmes.com

1-301-251-1161

Study Officials

• Karl Csaky, MD

  Texas Retina Associates

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2011
• First Posted: February 14, 2011
• Study Start: May 1, 2011
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: September 25, 2025
• Results First Posted: October 18, 2017

Record last verified: 2017-09

Locations

US (1)